Cleared Traditional

K984268 - VARIANT II HEMOGLOBIN A1C PROGRAM

K984268 is an FDA 510(k) clearance for VARIANT II HEMOGLOBIN A1C PROGRAM, manufactured by Bio-Rad. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K984268 · Bio-Rad · Hematology device
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Dec 1998
Decision
17d
Days
Class 2
Risk

K984268 is an FDA 510(k) clearance for the VARIANT II HEMOGLOBIN A1C PROGRAM. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on December 17, 1998 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7470 - 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

FDA 510(k) Submission Details - K984268

510(k) Number K984268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1998
Decision Date December 17, 1998
Days to Decision 17 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
96d faster than avg
Panel avg: 113d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCP Device Classification - Class 2, Special Controls

Product Code LCP Assay, Glycosylated Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
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 - LCP Assay, Glycosylated Hemoglobin

All 202
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K984268.
ABBOTT ARCHITECT GLYCATED HEMOGLOBIN
K991483 · Abbott Laboratories · Nov 1999
INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC
K990992 · Roche Diagnostics Corp. · Sep 1999
HEMOCHEK SAMPLE COLLECTION KIT
K984529 · Osborn Laboratories, Inc. · Jan 1999
ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
K983172 · Diabetes Technologies, Inc. (Dti) · Nov 1998
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
K983726 · Genzyme Corp. · Nov 1998
PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT
K983253 · Medisense, Inc. · Nov 1998