Cleared Traditional

OPTIMATE HEMOGLOBIN A1C (K896830) - FDA 510(k) Clearance

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

K896830 · Heraeus Kulzer, Inc. · Hematology device
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Sep 1990
Decision
281d
Days
Class 2
Risk

K896830 is an FDA 510(k) clearance for the OPTIMATE HEMOGLOBIN A1C. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Elkhart, US). The FDA issued a Cleared decision on September 11, 1990 after a review of 281 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K896830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1989
Decision Date September 11, 1990
Days to Decision 281 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 113d · This submission: 281d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 85
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K896830.
BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT
K905709 · Beckman Instruments, Inc. · Sep 1991
AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM
K911625 · Heraeus Kulzer, Inc. · Sep 1991
ABBOTT VISION(TM) GLYCATED HB
K904027 · Abbott Laboratories · Feb 1991
COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581
K901414 · Helena Laboratories · Jun 1990
ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY
K900718 · Roche Diagnostic Systems, Inc. · Jun 1990
REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207
K893224 · Helena Laboratories · Jun 1989