Cleared Traditional

K913614 - FRUCTOSAMINE ABG21 TEST SYSTEM

K913614 is an FDA 510(k) clearance for FRUCTOSAMINE ABG21 TEST SYSTEM, 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 111-day FDA review.

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

FDA 510(k) Submission Details - K913614

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.

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 K913614.
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AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM
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