Glycomat Green HBA2 Estimation Reagent Kit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K924496 FDA 510(k)
- FDA Product Code
- JPD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7400 FDA 510(k)
- Regulation Number
- 864.7400 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Hemoglobin A2 Quantitation Reagent Kit, classified under FDA product code JPD and regulation 864.7400. It is designed for the in vitro estimation of hemoglobin A2 (HBA2) levels in blood samples, a key diagnostic marker for conditions such as thalassemia and other hemoglobinopathies. The kit provides reagents necessary for automated or semi-automated analysis in clinical hematology laboratories.
The Glycomat Green HBA2 Estimation Reagent Kit is supplied as a ready-to-use diagnostic tool for laboratory settings. It is intended for single-use per manufacturer specifications and requires no additional sterilization. The kit is not MRI-compatible and must be stored under controlled conditions as per the provided instructions. Authorized for use in the United States under FDA 510(k) clearance (K924496), it adheres to traditional review standards and is classified as a Class II medical device.
Frequently asked questions
What clinical conditions is this reagent kit primarily used to help diagnose or monitor?
The Glycomat Green HBA2 Estimation Reagent Kit is designed for quantifying hemoglobin A2 (HBA2) levels in blood samples, which is a critical diagnostic marker for conditions like thalassemia and other hemoglobinopathies. Elevated or abnormal HBA2 levels can indicate these disorders, making this kit useful for screening and monitoring patients suspected of or diagnosed with such conditions.
Is this reagent kit intended for use in automated or manual laboratory systems, and how is it supplied?
The kit is specifically formulated for automated or semi-automated analysis in clinical hematology laboratories. It is supplied as a ready-to-use diagnostic tool, meaning no additional preparation or sterilization is required before use. Each kit is designed for single-use, ensuring consistency and reliability in test results.
How should this reagent kit be stored, and are there any special handling requirements?
The Glycomat Green HBA2 Estimation Reagent Kit must be stored under controlled conditions as outlined in the provided instructions. While the exact storage specifications aren’t detailed here, it’s important to follow the manufacturer’s guidelines to maintain reagent integrity. Unlike some devices, it does not require sterilization and is not MRI-compatible, so magnetic resonance environments should be avoided.
What regulatory pathway was followed for FDA clearance, and what does this mean for users?
The kit was cleared through the FDA’s 510(k) pathway under traditional review standards, with a clearance number of K924496. This means the manufacturer demonstrated that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness requirements for Class II medical devices. Users can rely on this clearance as confirmation of the kit’s regulatory compliance for hemoglobin A2 estimation in clinical settings.
Are there multiple versions or sizes of this reagent kit, and how can I identify the correct one for my lab?
The data provided lists multiple registration numbers (e.g., 1000487132, 3005529799) associated with this kit, which may correspond to different lot numbers, expiration dates, or minor variations in formulation. While the core functionality remains the same, you should verify the specific registration number or batch details on the kit packaging to ensure compatibility with your laboratory’s automated or semi-automated systems. Always cross-reference with the manufacturer’s documentation for precise usage instructions.
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: GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT (K924496) — FDA 510 (k ..., GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT 510(k) K924496 - FDA.report, Glycomat Green Hba2 Estimation Reagent Kit - Beudamed, Drew-Scientific FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K924496 | Class II | Active |
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Manufacturer
- Manufacturer
- Drew Scientific , Ltd.
Sources (1)
- FDA 510(k) K924496 24 fields · synced Sep 18, 2026