Cleared Traditional

K800794 - FAST HEMOGLOBIN CONTROL-LYOPHILIZED

K800794 is the FDA 510(k) clearance for FAST HEMOGLOBIN CONTROL-LYOPHILIZED by Isolab, Inc.. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K800794 · Isolab, Inc. · Chemistry device
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Apr 1980
Decision
20d
Days
Class 2
Risk

K800794 is an FDA 510(k) clearance for the FAST HEMOGLOBIN CONTROL-LYOPHILIZED. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Isolab, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 29, 1980 after a review of 20 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 Isolab, Inc. devices

Submission Details

510(k) Number K800794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1980
Decision Date April 29, 1980
Days to Decision 20 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
68d faster than avg
Panel avg: 88d · This submission: 20d
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 K800794.
HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH
K800857 · Helena Laboratories · Sep 1980
GLYCOSYLATED HEMOGLOBIN KIT
K801561 · Amersham Corp. · Aug 1980
LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT
K801289 · Leeco Diagnostics, Inc. · Jun 1980
CORNING GLYCOSYLATED HEMOGLOBIN SET
K791777 · Corning Medical & Scientific · Nov 1979
A-GENT GLYCOSPEC
K791642 · Abbott Laboratories · Oct 1979
FAST FLOW #60310
K791365 · Hi Chem, Inc. · Sep 1979