Cleared Traditional

K911625 - AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM

K911625 is an FDA 510(k) clearance for AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K911625 · Heraeus Kulzer, Inc. · Hematology device
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Sep 1991
Decision
147d
Days
Class 2
Risk

K911625 is an FDA 510(k) clearance for the AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Mishawaka, US). The FDA issued a Cleared decision on September 5, 1991 after a review of 147 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K911625

510(k) Number K911625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1991
Decision Date September 05, 1991
Days to Decision 147 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
34d slower than avg
Panel avg: 113d · This submission: 147d
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 214
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K911625.
FRUCTOSAMINE ABG21 TEST SYSTEM
K913614 · Boehringer Mannheim Corp. · Dec 1991
BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT
K912748 · Binax, Inc. · Oct 1991
BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT
K905709 · Beckman Instruments, Inc. · Sep 1991
ABBOTT VISION(TM) GLYCATED HB
K904027 · Abbott Laboratories · Feb 1991
GLYC-AFFIN(TM)-GA
K905513 · Isolab, Inc. · Jan 1991
GLYC-AFFIN GP
K904814 · Isolab, Inc. · Dec 1990