Cleared Traditional

K904027 - ABBOTT VISION(TM) GLYCATED HB

K904027 is an FDA 510(k) clearance for ABBOTT VISION(TM) GLYCATED HB, 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 161-day FDA review.

K904027 · Abbott Laboratories · Hematology device
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Feb 1991
Decision
161d
Days
Class 2
Risk

K904027 is an FDA 510(k) clearance for the ABBOTT VISION(TM) GLYCATED HB. 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 February 7, 1991 after a review of 161 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 - K904027

510(k) Number K904027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1990
Decision Date February 07, 1991
Days to Decision 161 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
48d slower than avg
Panel avg: 113d · This submission: 161d
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 K904027.
BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT
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K905709 · Beckman Instruments, Inc. · Sep 1991
AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM
K911625 · Heraeus Kulzer, Inc. · Sep 1991
GLYC-AFFIN(TM)-GA
K905513 · Isolab, Inc. · Jan 1991
GLYC-AFFIN GP
K904814 · Isolab, Inc. · Dec 1990
OPTIMATE HEMOGLOBIN A1C
K896830 · Heraeus Kulzer, Inc. · Sep 1990