Cleared Traditional

K031380 - OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)

K031380 is an FDA 510(k) clearance for OLYMPUS HBA1C REAGENT, manufactured by Olympus America, Inc.. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K031380 · Olympus America, Inc. · Chemistry device
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Nov 2003
Decision
197d
Days
Class 2
Risk

K031380 is an FDA 510(k) clearance for the OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (C.... Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Olympus America, Inc. (Irving, US). The FDA issued a Cleared decision on November 14, 2003 after a review of 197 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 Olympus America, Inc. devices

FDA 510(k) Submission Details - K031380

510(k) Number K031380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2003
Decision Date November 14, 2003
Days to Decision 197 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 88d · This submission: 197d
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 210
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K031380.
BIO-RAD D-10 DUAL PROGRAM
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MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS
K033674 · Seradyn, Inc. · Feb 2004
ATAC HEMOGLOBIN A1C REAGENT KIT
K031042 · Clinical Data, Inc. · Nov 2003
ARKIT HBA1C
K030553 · Arkray, Inc. · Sep 2003
D-10 HEMOGLOBIN A1C
K031043 · Bio-Rad Laboratories, Inc. · Aug 2003