Cleared Traditional

K880673 - GHB SAMPLE PAPER

K880673 is the FDA 510(k) clearance for GHB SAMPLE PAPER by Isolab, Inc.. It is a Class 2 Hematology device (product code LCP) cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K880673 · Isolab, Inc. · Hematology device
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Nov 1988
Decision
277d
Days
Class 2
Risk

K880673 is an FDA 510(k) clearance for the GHB SAMPLE PAPER. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on November 22, 1988 after a review of 277 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Isolab, Inc. devices

Submission Details

510(k) Number K880673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1988
Decision Date November 22, 1988
Days to Decision 277 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
164d slower than avg
Panel avg: 113d · This submission: 277d
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 K880673.
REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207
K893224 · Helena Laboratories · Jun 1989
SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE
K884184 · Sigma Diagnostics, Inc. · Mar 1989
LABILE LYSING REAGENT
K884315 · Helena Laboratories · Dec 1988
REP GLYCO SYSTEM
K881863 · Helena Laboratories · Sep 1988
BIO-RAD HEMOGLOBIN DETECTOR
K882051 · Bio-Rad · Aug 1988
DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY
K882222 · Bio-Rad · Aug 1988