Cleared Traditional

K831478 - LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN

K831478 is the FDA 510(k) clearance for LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN by Bio-Rad. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K831478 · Bio-Rad · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1983
Decision
44d
Days
Class 2
Risk

K831478 is an FDA 510(k) clearance for the LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Bio-Rad (Mchenry, US). The FDA issued a Cleared decision on June 22, 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 Bio-Rad devices

Submission Details

510(k) Number K831478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1983
Decision Date June 22, 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.

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 Chemistry 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 K831478.
GLYCO-JE,E CPMTRP
K833356 · Helena Laboratories · Nov 1983
A-GENT GLYCOSYLATED HEMOGLOBIN
K832775 · Abbott Laboratories · Sep 1983
TITAN GEL GLYCO-HEME SYSTEM
K832087 · Helena Laboratories · Aug 1983
HEMOGLOBIN ALC BY COLUMN TEST
K830935 · Bio-Rad · Jun 1983
GLYCO HB QUIK COLUMN PROCEDURE
K823869 · Helena Laboratories · Feb 1983
GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY
K822867 · Isolab, Inc. · Dec 1982