Cleared Traditional

K832775 - A-GENT GLYCOSYLATED HEMOGLOBIN

K832775 is an FDA 510(k) clearance for A-GENT GLYCOSYLATED HEMOGLOBIN, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K832775 · Abbott Laboratories · Chemistry device
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Sep 1983
Decision
44d
Days
Class 2
Risk

K832775 is an FDA 510(k) clearance for the A-GENT GLYCOSYLATED 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, 1983 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K832775

510(k) Number K832775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1983
Decision Date September 29, 1983
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 88d · This submission: 44d
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 Chemistry 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 K832775.
ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB
K834294 · Emd Chemicals, Inc. · Jan 1984
AUTO AIC ANALYZER SYSTEM
K833772 · Helena Laboratories · Jan 1984
GLYCO-JE,E CPMTRP
K833356 · Helena Laboratories · Nov 1983
TITAN GEL GLYCO-HEME SYSTEM
K832087 · Helena Laboratories · Aug 1983
LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN
K831478 · Bio-Rad · Jun 1983
HEMOGLOBIN ALC BY COLUMN TEST
K830935 · Bio-Rad · Jun 1983