DS30 HCY Blood Collection Tubes
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K012152 FDA 510(k)
- FDA Product Code
- GIM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1675 FDA 510(k)
- Regulation Number
- 862.1675 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DS30 HCY Blood Collection Tubes are Vacuum Sample Tubes with Anticoagulant, designed for the collection and stabilization of blood samples. These tubes contain EDTA and 3-deazaadenosine to preserve homocysteine (HCY) levels, ensuring accurate clinical chemistry testing.
Used primarily in clinical laboratory settings, these single-use, sterile tubes are intended for collecting 2.5 mL of blood. They comply with 21 CFR 862.1675 and have received FDA 510(k) clearance under the Traditional pathway, classified as Class II medical devices. Storage and handling follow standard aseptic protocols for evacuated blood collection systems.
Frequently asked questions
What is the primary purpose of the DS30 HCY Blood Collection Tubes and how does their design support clinical accuracy?
The DS30 HCY Blood Collection Tubes are designed specifically for collecting and stabilizing blood samples to measure homocysteine (HCY) levels accurately. They contain EDTA and 3-deazaadenosine, which preserve HCY stability during storage and transport, ensuring reliable results for clinical chemistry testing in laboratory settings.
Are these tubes intended for single-use or repeated use, and what precautions should be taken during handling?
These tubes are explicitly designed for single-use only and are sterile. They follow standard aseptic protocols for evacuated blood collection systems, meaning they must be handled with care to maintain sterility and prevent contamination before use.
What volume of blood can each tube collect, and how does this compare to standard blood collection tubes?
Each DS30 HCY Blood Collection Tube is designed to collect 2.5 mL of blood, which is slightly smaller than some conventional tubes (often 3–5 mL). This capacity is optimized for precise HCY measurement without diluting the sample.
How should these tubes be stored, and are there any special conditions required?
Storage follows standard protocols for evacuated blood collection systems, meaning they should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Since they are sterile and single-use, they should remain unopened until use to preserve integrity.
What regulatory pathway was followed for FDA clearance, and which advisory committee reviewed this submission?
The DS30 HCY Blood Collection Tubes received FDA 510(k) clearance under the Traditional pathway, classified as a Class II medical device. The submission was reviewed by the Clinical Chemistry (CH) Advisory Committee, reflecting their specialized focus on laboratory chemistry devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DS30 HCY BLOOD COLLECTION TUBES (K012152) — FDA 510 (k) | Innolitics, DS30 HCY BLOOD COLLECTION TUBES 510 (k) K012152 - FDA.report, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K012152 | Class II | Active |
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Manufacturer
- Manufacturer
- Drew Scientific , Ltd.
Sources (1)
- FDA 510(k) K012152 24 fields · synced Sep 18, 2026