Cleared Traditional

FRUCTOSAMINE ABG21 TEST SYSTEM (K913614) - FDA 510(k) Clearance

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

K913614 · Boehringer Mannheim Corp. · Hematology device
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Dec 1991
Decision
111d
Days
Class 2
Risk

K913614 is an FDA 510(k) clearance for the FRUCTOSAMINE ABG21 TEST SYSTEM. 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 December 2, 1991 after a review of 111 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 Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K913614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1991
Decision Date December 02, 1991
Days to Decision 111 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
2d faster than avg
Panel avg: 113d · This submission: 111d
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 K913614.
MODIFICATION COLUMNMATE
K920820 · Helena Laboratories · Aug 1992
COLUMNMATE II
K921676 · Helena Laboratories · Jul 1992
GLYCO-TEK AFFINITY COLUMN KIT
K921305 · Helena Laboratories · Jun 1992
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