Cleared Traditional

VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM (K972609) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K972609 · Bio-Rad · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
26d
Days
Class 2
Risk

K972609 is an FDA 510(k) clearance for the VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM. Classified as Fluorescent Immunoassay Gentamicin (product code LCQ), Class II - Special Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on August 6, 1997 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.3450 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bio-Rad devices

Submission Details

510(k) Number K972609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1997
Decision Date August 06, 1997
Days to Decision 26 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 113d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCQ Fluorescent Immunoassay Gentamicin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - LCQ Fluorescent Immunoassay Gentamicin

All 18
Devices cleared under the same product code (LCQ) and FDA review panel - the closest regulatory comparables to K972609.
COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS
K945523 · Roche Diagnostic Systems, Inc. · Mar 1995
'TDXFLX ANALYZER
K904226 · Abbott Laboratories · Oct 1990
COBAS REAGENTS FOR GENTAMICIN & CALIBRAT
K843827 · Roche Diagnostic Systems, Inc. · Feb 1985
SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY
K820285 · Syva Co. · Feb 1982
CYBREX GENTAMICIN
K801084 · Abbott Laboratories · May 1980