Premier HB9210 HBA1C Analyzer
by Primus Corporation Dba Trinity Biotech
510(k) K112015
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK112015 | Date22 Nov 2011 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LCP
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7470
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Premier HB9210 HbA1c Analyzer is an in vitro diagnostic device classified as an assay for glycosylated hemoglobin (HbA1c). It employs high-performance liquid chromatography (HPLC) with boronate affinity to quantitatively measure HbA1c levels in blood samples, aiding in the diagnosis and management of diabetes.
This device is intended for use in clinical laboratories and healthcare settings, supplied as a reusable instrument with disposable consumables. It operates under non-sterile conditions and is not MRI-compatible. The analyzer is authorized for use in the United States following FDA 510(k) clearance (K112015) under the Traditional pathway, adhering to regulatory requirements for Class 2 Chemistry devices (product code LCP)
Questions
AI-generated answers, 19 Sep 2026
What types of blood samples can the Premier HB9210 HbA1c Analyzer measure, and how is it primarily used in clinical settings?
The Premier HB9210 HbA1c Analyzer is designed to quantitatively measure glycosylated hemoglobin (HbA1c) levels in blood samples using high-performance liquid chromatography (HPLC) with boronate affinity. It is primarily used in clinical laboratories and healthcare settings for the diagnosis and management of diabetes by providing accurate HbA1c readings, which reflect average blood glucose levels over the past 2–3 months.
Is the Premier HB9210 HbA1c Analyzer a single-use device, or does it require disposable consumables, and how should those be handled?
The Premier HB9210 HbA1c Analyzer is a reusable instrument, but it operates with disposable consumables for sample analysis. Since the device itself is not sterile, proper handling of consumables and adherence to manufacturer guidelines for single-use components (like sample vials or cartridges) is essential to maintain accuracy and prevent cross-contamination.
What regulatory pathway was followed for FDA clearance of the Premier HB9210 HbA1c Analyzer, and what does this mean for its use in the U.S.?
The Premier HB9210 HbA1c Analyzer received FDA clearance through the Traditional 510(k) pathway (K112015) under the classification of Class 2 Chemistry devices (product code LCP). This means the device was determined to be substantially equivalent to a legally marketed predicate device and is authorized for use in the United States following this regulatory process.
How should the Premier HB9210 HbA1c Analyzer be stored, and are there any special considerations for its maintenance?
While specific storage instructions are not detailed in the provided data, as a reusable instrument, the Premier HB9210 should be stored in a clean, dry environment following the manufacturer’s guidelines to preserve its functionality. Since it is not MRI-compatible, it should also be kept away from magnetic fields. Regular maintenance, including calibration and cleaning, is likely required to ensure accurate and reliable performance.