Cleared Traditional

K961674 - ROCHE UNIMATE FRUCTOSAMINE REAGENT

K961674 is the FDA 510(k) clearance for ROCHE UNIMATE FRUCTOSAMINE REAGENT by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (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

Submission Details

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.

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 Chemistry devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 127
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K961674.
VARIANT II HEMOGLOBIN A1C PROGRAM
K984268 · Bio-Rad · Dec 1998
ACCU-CHEK A1C HEMOGLOBIN TEST
K974491 · Boehringer Mannheim Corp. · May 1998
SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT
K973696 · Beckman Instruments, Inc. · Nov 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