Cleared Traditional

K955087 - HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS

K955087 is an FDA 510(k) clearance for HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS F..., manufactured by Bayer Corp.. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K955087 · Bayer Corp. · Hematology device
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Jun 1996
Decision
219d
Days
Class 2
Risk

K955087 is an FDA 510(k) clearance for the HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-V.... Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on June 13, 1996 after a review of 219 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.

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FDA 510(k) Submission Details - K955087

510(k) Number K955087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1995
Decision Date June 13, 1996
Days to Decision 219 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 113d · This submission: 219d
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 K955087.
LXN FRUCTOSAMINE TEST SYSTEM
K962597 · Lxn Corp. · Jun 1997
HYDRAGEL 15 HB A1C KIT
K963844 · Morax · Apr 1997
ROCHE UNIMATE FRUCTOSAMINE REAGENT
K961674 · Roche Diagnostic Systems, Inc. · Sep 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
ABBOTT VISION GLYCATED HB, MODIFICATION
K936285 · Abbott Laboratories · Jun 1995