Cleared Traditional

GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN (K852986) - FDA 510(k) Clearance

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

K852986 · Clinical Technology Corp. · Hematology device
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Aug 1985
Decision
35d
Days
Class 2
Risk

K852986 is an FDA 510(k) clearance for the GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Clinical Technology Corp. (Rocky Point, US). The FDA issued a Cleared decision on August 19, 1985 after a review of 35 days - a notably fast clearance 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: 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 Clinical Technology Corp. devices

Submission Details

510(k) Number K852986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1985
Decision Date August 19, 1985
Days to Decision 35 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 113d · This submission: 35d
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 87
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K852986.
FRUCTOSAMINE TEST (ROCHE)
K854010 · Roche Diagnostic Systems, Inc. · Dec 1987
MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER
K871388 · Bio-Rad · Jul 1987
HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)
K862371 · Bio-Rad · Sep 1986
DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM
K851636 · Bio-Rad · Jul 1985
GLYCO-TEK AFFINITY COLUMN
K842689 · Helena Laboratories · Oct 1984
AUTO AIC ANALYZER SYSTEM
K833772 · Helena Laboratories · Jan 1984