Cleared Traditional

K000885 - DRX HBA1C - FOR PRESCRIPTION HOME USE

K000885 is an FDA 510(k) clearance for DRX HBA1C - FOR PRESCRIPTION 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 190-day FDA review.

K000885 · Metrika, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
190d
Days
Class 2
Risk

K000885 is an FDA 510(k) clearance for the DRX HBA1C - FOR PRESCRIPTION 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 September 26, 2000 after a review of 190 days - an extended review cycle.

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 - K000885

510(k) Number K000885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2000
Decision Date September 26, 2000
Days to Decision 190 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
77d slower than avg
Panel avg: 113d · This submission: 190d
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 K000885.
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
K010748 · Beckman Coulter, Inc. · Jul 2001
VARIANT II TOTAL GHB
K003280 · Bio-Rad · Dec 2000
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
K003120 · Roche Diagnostics Corp. · Dec 2000
ABBOTT IMX GLYCATED HEMOGLOBIN II
K992085 · Abbott Laboratories · May 2000
NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY
K993131 · Primus, Inc. · May 2000
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
K000239 · Genzyme Corp. · Mar 2000