Cleared Traditional

K990992 - INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN...

K990992 is the FDA 510(k) clearance for INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN... by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K990992 · Roche Diagnostics Corp. · Chemistry device
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Sep 1999
Decision
190d
Days
Class 2
Risk

K990992 is an FDA 510(k) clearance for the INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 30, 1999 after a review of 190 days - an extended review cycle.

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 Diagnostics Corp. devices

Submission Details

510(k) Number K990992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1999
Decision Date September 30, 1999
Days to Decision 190 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 88d · This submission: 190d
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 110
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K990992.
ABBOTT IMX GLYCATED HEMOGLOBIN II
K992085 · Abbott Laboratories · May 2000
FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET
K993590 · Pointe Scientific, Inc., · Dec 1999
ABBOTT ARCHITECT GLYCATED HEMOGLOBIN
K991483 · Abbott Laboratories · Nov 1999
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