Cleared Traditional

K990992 - INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC

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

K990992 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K990992

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.

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 235
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K990992.
SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC
K991850 · Biosafe Laboratories, Inc. · Nov 1999
PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II
K992921 · Primus Corp. · Nov 1999
ABBOTT ARCHITECT GLYCATED HEMOGLOBIN
K991483 · Abbott Laboratories · Nov 1999
HEMOCHEK SAMPLE COLLECTION KIT
K984529 · Osborn Laboratories, Inc. · Jan 1999
VARIANT II HEMOGLOBIN A1C PROGRAM
K984268 · Bio-Rad · Dec 1998
ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
K983172 · Diabetes Technologies, Inc. (Dti) · Nov 1998
K990992 · INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC
Download PDF FDA Summary Roche Diagnostics Cor…