Cleared Traditional

K921831 - IMX GLYCATED HEMOGLOBIN

K921831 is an FDA 510(k) clearance for IMX GLYCATED HEMOGLOBIN, manufactured by Abbott Laboratories. 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.

K921831 · Abbott Laboratories · Hematology device
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Sep 1992
Decision
166d
Days
Class 2
Risk

K921831 is an FDA 510(k) clearance for the IMX(R) GLYCATED HEMOGLOBIN. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 29, 1992 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K921831

510(k) Number K921831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1992
Decision Date September 29, 1992
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 149
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K921831.
GLYCOHEMOGLOBIN
K931183 · Teco Diagnostics · Nov 1993
VARIANT(TM) HEMOGLOBIN A 1C PROGRAM
K926469 · Bio-Rad · Mar 1993
BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED
K925204 · Beckman Instruments, Inc. · Jan 1993
MODIFICATION COLUMNMATE
K920820 · Helena Laboratories · Aug 1992
REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT
K920397 · Medical Analysis Systems, Inc. · Aug 1992
POINTE 750 GLYCOMETER
K920449 · Pointe Scientific, Inc., · Jul 1992