Cleared Traditional

K022661 - A1CNOW FOR HOME USE

K022661 is an FDA 510(k) clearance for A1CNOW FOR HOME USE, manufactured by Metrika, Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K022661

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.

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 203
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K022661.
HEMOGLOBIN A1C REAGENT SET
K031539 · Pointe Scientific, Inc., · Aug 2003
GLYCA-DIRECT FRUCTOSAMINE
K023654 · Polymedco, Inc. · May 2003
RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
K023763 · Randox Laboratories, Ltd. · Jan 2003
RANDOX HAEMOGLOBIN A1C
K021897 · Randox Laboratories, Ltd. · Nov 2002
POLYMEDCO HBA1C TEST
K020532 · Polymedco, Inc. · Apr 2002
DIMENSION HAIC ASSAY, MODEL DF105
K011852 · Dade Behring, Inc. · Nov 2001