Cleared Traditional

K033674 - MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS

K033674 is an FDA 510(k) clearance for MULTIGENT HEMOGLOBIN A1C (REAGENTS), manufactured by Seradyn, Inc.. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K033674 · Seradyn, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Feb 2004
Decision
77d
Days
Class 2
Risk

K033674 is an FDA 510(k) clearance for the MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 9, 2004 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Seradyn, Inc. devices

FDA 510(k) Submission Details - K033674

510(k) Number K033674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2003
Decision Date February 09, 2004
Days to Decision 77 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
11d faster than avg
Panel avg: 88d · This submission: 77d
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 202
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K033674.
G5 I HBA1C TEST, G5 II HBA1C TEST
K041635 · Provalis Diagnostics , Ltd. · Aug 2004
BIO-RAD D-10 DUAL PROGRAM
K041444 · Bio-Rad Laboratories, Inc. · Jun 2004
VARIANT II HEMOGLOBIN A1C
K040872 · Bio-Rad Laboratories, Inc. · Apr 2004
OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)
K031380 · Olympus America, Inc. · Nov 2003
ATAC HEMOGLOBIN A1C REAGENT KIT
K031042 · Clinical Data, Inc. · Nov 2003
ARKIT HBA1C
K030553 · Arkray, Inc. · Sep 2003