Cleared Traditional

K810958 - GLYCOHEMOGLOBIN

K810958 is an FDA 510(k) clearance for GLYCOHEMOGLOBIN, manufactured by Macomb Chemical Co.. The device is a Class 2 Toxicology device with product code LCP cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K810958 · Macomb Chemical Co. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1981
Decision
161d
Days
Class 2
Risk

K810958 is an FDA 510(k) clearance for the GLYCOHEMOGLOBIN. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Macomb Chemical Co. (Walker, US). The FDA issued a Cleared decision on September 16, 1981 after a review of 161 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 864.7470 - the FDA toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Macomb Chemical Co. devices

FDA 510(k) Submission Details - K810958

510(k) Number K810958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1981
Decision Date September 16, 1981
Days to Decision 161 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 87d · 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 Toxicology devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 211
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K810958.
GLYCO HB QUIK COLUMN PROCEDURE
K823869 · Helena Laboratories · Feb 1983
GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY
K822867 · Isolab, Inc. · Dec 1982
HEMOGLOBIN ALC BY COLUMN TEST
K822977 · Bio-Rad · Nov 1982
ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S
K811567 · Ortho Diagnostic Systems, Inc. · Sep 1981
CORDISNHYPERION HEMOGLOBIN A1 TEST SYS
K812242 · Cordis Corp. · Sep 1981
BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST
K811710 · Bio-Rad · Jul 1981