Cleared Traditional

K902457 - ABNORMAL GLYCOHEMOGLOBIN CONTROL

K902457 is the FDA 510(k) clearance for ABNORMAL GLYCOHEMOGLOBIN CONTROL by Analytical Control Systems, Inc.. It is a Class 2 Hematology device (product code LCP) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K902457 · Analytical Control Systems, Inc. · Hematology device
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Jul 1990
Decision
50d
Days
Class 2
Risk

K902457 is an FDA 510(k) clearance for the ABNORMAL GLYCOHEMOGLOBIN CONTROL. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Analytical Control Systems, Inc. (Fishers, US). The FDA issued a Cleared decision on July 24, 1990 after a review of 50 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 Analytical Control Systems, Inc. devices

Submission Details

510(k) Number K902457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1990
Decision Date July 24, 1990
Days to Decision 50 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
63d faster than avg
Panel avg: 113d · This submission: 50d
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 136
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K902457.
GLYC-AFFIN GP
K904814 · Isolab, Inc. · Dec 1990
OPTIMATE HEMOGLOBIN A1C
K896830 · Heraeus Kulzer, Inc. · Sep 1990
ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)
K902455 · Analytical Control Systems, Inc. · Jul 1990
COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581
K901414 · Helena Laboratories · Jun 1990
ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY
K900718 · Roche Diagnostic Systems, Inc. · Jun 1990
REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207
K893224 · Helena Laboratories · Jun 1989