Cleared Traditional

K881863 - REP GLYCO SYSTEM

K881863 is an FDA 510(k) clearance for REP GLYCO SYSTEM, manufactured by Helena Laboratories. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K881863 · Helena Laboratories · Hematology device
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Sep 1988
Decision
150d
Days
Class 2
Risk

K881863 is an FDA 510(k) clearance for the REP GLYCO SYSTEM. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on September 30, 1988 after a review of 150 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 Helena Laboratories devices

FDA 510(k) Submission Details - K881863

510(k) Number K881863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1988
Decision Date September 30, 1988
Days to Decision 150 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
37d slower than avg
Panel avg: 113d · This submission: 150d
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 Hematology devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 202
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K881863.
SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE
K884184 · Sigma Diagnostics, Inc. · Mar 1989
LABILE LYSING REAGENT
K884315 · Helena Laboratories · Dec 1988
GHB SAMPLE PAPER
K880673 · Isolab, Inc. · Nov 1988
BINAX EQUATE GLYCOHEMOGLOBIN
K874749 · Binax, Inc. · Aug 1988
BIO-RAD HEMOGLOBIN DETECTOR
K882051 · Bio-Rad · Aug 1988
DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY
K882222 · Bio-Rad · Aug 1988