Cleared Special

K033847 - A1CNOW FOR HOME AND PROFESSIONAL USE

K033847 is the FDA 510(k) clearance for A1CNOW FOR HOME AND PROFESSIONAL USE by Metrika, Inc.. It is a Class 2 Chemistry device (product code LCP) cleared through the Special 510(k) pathway after a 12-day FDA review.

K033847 · Metrika, Inc. · Chemistry device
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Dec 2003
Decision
12d
Days
Class 2
Risk

K033847 is an FDA 510(k) clearance for the A1CNOW FOR HOME AND PROFESSIONAL USE. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Metrika, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 23, 2003 after a review of 12 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Metrika, Inc. devices

Submission Details

510(k) Number K033847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2003
Decision Date December 23, 2003
Days to Decision 12 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 88d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

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 137
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K033847.
THE VITROS 5,1 FS CHEMISTRY SYSTEM
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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
D-10 HEMOGLOBIN A1C
K031043 · Bio-Rad Laboratories, Inc. · Aug 2003