Cleared Traditional

K884315 - LABILE LYSING REAGENT

K884315 is the FDA 510(k) clearance for LABILE LYSING REAGENT by Helena Laboratories. It is a Class 2 Hematology device (product code LCP) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K884315 · Helena Laboratories · Hematology device
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Dec 1988
Decision
75d
Days
Class 2
Risk

K884315 is an FDA 510(k) clearance for the LABILE LYSING REAGENT. 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 December 27, 1988 after a review of 75 days - a notably fast clearance 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: 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 Helena Laboratories devices

Submission Details

510(k) Number K884315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1988
Decision Date December 27, 1988
Days to Decision 75 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
38d faster than avg
Panel avg: 113d · This submission: 75d
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 K884315.
ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY
K900718 · Roche Diagnostic Systems, Inc. · Jun 1990
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
GHB SAMPLE PAPER
K880673 · Isolab, Inc. · Nov 1988
REP GLYCO SYSTEM
K881863 · Helena Laboratories · Sep 1988
BIO-RAD HEMOGLOBIN DETECTOR
K882051 · Bio-Rad · Aug 1988