About Supera Fulfillment:
ISO 13485 Medical Kit Assembly in Houston

Medical Kit Assembly Built by Clinical Laboratory Professionals

Who are we?

25

Clinical Lab Management

kit assembly and healthcare logistics

Supera Fulfillment is an FDA-registered device establishment and ISO 13485 certified contract manufacturer based in Houston, Texas. Founded in 2020, Supera assembles specimen collection kits and at-home testing kits in an ISO Class 7 cleanroom for diagnostic laboratories, genomics and biotech companies, medical device manufacturers, and direct-to-consumer health brands running at-home testing programs across the United States.

Kit assembly makes the finished kit a device, which makes Supera the manufacturer of record. Every kit lot is released against a documented QC record before it ships, with lot-level traceability from component receipt through delivery. Storage and distribution come after that, as the last step of a manufacturing process rather than a service sold on its own.

Built by a Scientist and a Clinical Lab Director. Still Run That Way.

Supera exists because its founders spent 25 years on opposite ends of the same problem. Both of them started with patient specimens in their hands.

Sitara “Tara” Waidyaratne spent more than 25 years running clinical laboratories before founding Supera, most recently as Director and VP of Laboratory Operations at Companion Dx and Access Dx, leading teams of up to 200 processing thousands of high-complexity specimens daily. She knows what a bad kit costs, because she was the one who opened the box and found the wrong tube, the missing requisition, the label that would not scan. As Founder and President, she is on the floor daily, and the quality system is hers.

Michael Brown ran clinical research at Baylor College of Medicine, working with HIV patients and their specimens, before moving into laboratory supply and distribution, where he spent more than two decades, most recently as Senior Vice President of Sales, Strategic Alliances and Biosolutions at Thomas Scientific, before joining Supera full time in 2024. He handled patient samples before he ever sold a tube, and he knows which components are genuinely available, which manufacturers hold their lead times, and which substitutions are safe when a supply chain moves. As Co-Founder and Chief Commercial Officer, he holds a degree in genetics and biochemistry from Texas A&M University and an MBA from the University of Houston-Clear Lake.

Tara founded Supera in 2020, in the middle of a pandemic, building collection kits when almost nobody could source components at all. Michael was in it from that first year and came on full time in 2024.

Most fulfillment companies are logistics operations that learned healthcare. Supera was built the other way around. That is why kits are assembled in an ISO Class 7 cleanroom, under an ISO 13485 quality system, in an FDA-registered facility, and why the same standards govern how a kit is stored and shipped as how it is built.

Comprehensive Healthcare Solutions

Supera Fulfillment offers a full spectrum of services including specimen collection kit assembly, medical kit manufacturing, regulated storage and distribution, medical supply distribution, and precision aliquoting services using advanced Hamilton STAR automated liquid handling systems. Our capabilities extend from small pilot programs with hundreds of units to large-scale commercial production of tens of thousands of kits monthly, providing the scalability that growing healthcare organizations require.

Responsive Partnership

What truly distinguishes Supera Fulfillment is our responsiveness and dedication to client success. We provide same-day responses to all inquiries because we understand that laboratory timelines are critical. Our 24/7 emergency availability supports urgent needs including outbreak responses, unexpected supply shortages, and expedited program launches. Operating Monday through Friday from 8am to 5pm Central Time, with round-the-clock emergency support, we ensure your supply chain never becomes a bottleneck in delivering critical healthcare services.

Our Commitment

We’ve built Supera Fulfillment on the principle that exceptional service and strong client relationships drive mutual success, earning trust through consistent quality, regulatory expertise, and genuine partnership. Our team of dedicated professionals treats every project (whether a startup’s first product launch or an established laboratory’s ongoing distribution) with the same meticulous attention to detail and commitment to excellence.

Industry Involvement

Supera Fulfillment is a sponsor of the Patient Centric Sampling Interest Group, a not-for-profit organization working to develop and promote patient centric biological sampling. PCSIG brings together researchers, clinicians, device developers and laboratories around one question: how samples get collected closer to the patient and further from the clinic.

We sponsor PCSIG because the problems that group works through are the problems that decide whether a kit program survives contact with real patients. Device selection, sample stability outside a controlled environment, and what a collection method does to assay performance are not marketing questions. They determine whether the specimen arriving at the lab is usable.

PCSIG runs a free webinar program covering self sampling, device selection and clinical adoption of patient centric methods. Sessions are open to anyone. See upcoming and on demand webinars.

Frequently Asked Questions

What does Supera Fulfillment do?

Supera Fulfillment assembles specimen collection kits and at-home testing kits in an ISO Class 7 cleanroom in Houston, Texas. Kit assembly makes the finished kit a device, which makes Supera the manufacturer of record. Every kit lot is released against a documented QC record before it ships, with lot level traceability from component receipt through delivery.

Is Supera Fulfillment ISO 13485 certified?

Yes. Supera operates a certified ISO 13485 quality management system and is an FDA-registered device establishment. Component traceability, quality records and lot release documentation are maintained under that system, so when an auditor asks how a component was qualified, the answer already exists.

Does Supera support at-home testing programs?

Yes. At-home testing kit assembly and direct-to-patient fulfillment are core work. Supera builds at-home collection kits, ships them directly to patients and consumers, and supports the return path back to the testing laboratory. Programs using capillary blood collection, saliva, swab and other at-home collection formats are all supported under the same ISO 13485 quality system.

Is Supera Fulfillment a 3PL?

No. Supera is a contract manufacturer. Storage, pick and pack, and outbound distribution are part of the work, but they come after kit assembly as the last step of a manufacturing process rather than as a standalone logistics service. Companies searching for a medical device 3PL or a healthcare fulfillment partner usually need manufacturing controls that a conventional 3PL does not carry.

What kinds of companies does Supera work with?

Clinical diagnostic laboratories, genomics and biotech companies, medical device manufacturers, and direct-to-consumer health brands running at-home testing programs, across the United States.

How are specimen kits packaged for transport?

Kits intended for Category B specimen transport are built and packaged to UN3373 and IATA Packing Instruction 650, unless a program is documented as exempt or as Category A.

Where is Supera Fulfillment located?

3240 Fuqua St, Suite 3246, Houston, Texas 77047. Phone (346) 418-6137.

Partner With Us

Supera Fulfillment stands ready to support your diagnostic testing programs, clinical trials, at-home testing initiatives, and healthcare product distribution with the quality, compliance, and reliability your organization deserves. Contact us today to discover how our expertise can transform your healthcare logistics operations.

About Supera Fulfillment:ISO 13485 Medical Kit Assembly in Houston