Cleared Traditional

K974491 - ACCU-CHEK A1C HEMOGLOBIN TEST

K974491 is an FDA 510(k) clearance for ACCU-CHEK A1C HEMOGLOBIN TEST, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K974491 · Boehringer Mannheim Corp. · Hematology device
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May 1998
Decision
166d
Days
Class 2
Risk

K974491 is an FDA 510(k) clearance for the ACCU-CHEK A1C HEMOGLOBIN TEST. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 13, 1998 after a review of 166 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K974491

510(k) Number K974491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1997
Decision Date May 13, 1998
Days to Decision 166 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
53d slower than avg
Panel avg: 113d · This submission: 166d
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 147
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K974491.
INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC
K990992 · Roche Diagnostics Corp. · Sep 1999
VARIANT II HEMOGLOBIN A1C PROGRAM
K984268 · Bio-Rad · Dec 1998
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
K983726 · Genzyme Corp. · Nov 1998
SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT
K973696 · Beckman Instruments, Inc. · Nov 1997
A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER
K972265 · Tosoh Medics, Inc. · Sep 1997
ROCHE UNIMATE FRUCTOSAMINE REAGENT
K961674 · Roche Diagnostic Systems, Inc. · Sep 1996