Cleared Traditional

K022661 - A1CNOW FOR HOME USE

K022661 is the FDA 510(k) clearance for A1CNOW FOR HOME USE by Metrika, Inc.. It is a Class 2 Hematology device (product code LCP) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K022661 · Metrika, Inc. · Hematology device
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Dec 2002
Decision
126d
Days
Class 2
Risk

K022661 is an FDA 510(k) clearance for the A1CNOW FOR HOME 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 13, 2002 after a review of 126 days - within the typical 510(k) review window.

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.

View all Metrika, Inc. devices

Submission Details

510(k) Number K022661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2002
Decision Date December 13, 2002
Days to Decision 126 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 113d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Hematology 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 K022661.
D-10 HEMOGLOBIN A1C
K031043 · Bio-Rad Laboratories, Inc. · Aug 2003
HEMOGLOBIN A1C REAGENT SET
K031539 · Pointe Scientific, Inc., · Aug 2003
RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
K023763 · Randox Laboratories, Ltd. · Jan 2003
RANDOX HAEMOGLOBIN A1C
K021897 · Randox Laboratories, Ltd. · Nov 2002
DIMENSION HAIC ASSAY, MODEL DF105
K011852 · Dade Behring, Inc. · Nov 2001
INFINITY HBA KIT, MODELS 537-A, 537-B
K012410 · Sigma Diagnostics, Inc. · Oct 2001