Cleared Traditional

K961674 - ROCHE UNIMATE FRUCTOSAMINE REAGENT

K961674 is an FDA 510(k) clearance for ROCHE UNIMATE FRUCTOSAMINE REAGENT, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K961674 · Roche Diagnostic Systems, Inc. · Chemistry device
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Sep 1996
Decision
149d
Days
Class 2
Risk

K961674 is an FDA 510(k) clearance for the ROCHE UNIMATE FRUCTOSAMINE REAGENT. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on September 27, 1996 after a review of 149 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K961674

510(k) Number K961674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1996
Decision Date September 27, 1996
Days to Decision 149 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 88d · This submission: 149d
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 Chemistry devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 195
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K961674.
EZCHEK/HBA BLOOD COLLECTION KIT
K971919 · Flexsite Diagnostics, Inc. · Sep 1997
LXN FRUCTOSAMINE TEST SYSTEM
K962597 · Lxn Corp. · Jun 1997
HYDRAGEL 15 HB A1C KIT
K963844 · Morax · Apr 1997
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
COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN
K946274 · Helena Laboratories · Jul 1995