Cleared Traditional

K963844 - HYDRAGEL 15 HB A1C KIT

K963844 is an FDA 510(k) clearance for HYDRAGEL 15 HB A1C KIT, manufactured by Morax. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K963844 · Morax · Hematology device
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Apr 1997
Decision
209d
Days
Class 2
Risk

K963844 is an FDA 510(k) clearance for the HYDRAGEL 15 HB A1C KIT. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Morax (Chelsea, US). The FDA issued a Cleared decision on April 22, 1997 after a review of 209 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 Morax devices

FDA 510(k) Submission Details - K963844

510(k) Number K963844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1996
Decision Date April 22, 1997
Days to Decision 209 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 113d · This submission: 209d
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 K963844.
A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER
K972265 · Tosoh Medics, Inc. · Sep 1997
EZCHEK/HBA BLOOD COLLECTION KIT
K971919 · Flexsite Diagnostics, Inc. · Sep 1997
LXN FRUCTOSAMINE TEST SYSTEM
K962597 · Lxn Corp. · Jun 1997
ROCHE UNIMATE FRUCTOSAMINE REAGENT
K961674 · Roche Diagnostic Systems, Inc. · Sep 1996
HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
K955087 · Bayer Corp. · Jun 1996
ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P
K952337 · Roche Diagnostic Systems, Inc. · Feb 1996