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Metrika, Inc.

United StatesFDA applicant, unverified

Devices
11
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Metrika, Inc. makes

Metrika, Inc. manufactures point-of-care diagnostic devices for glucose monitoring, hemoglobin A1c testing, and osteocalcin measurement. Their products include handheld analyzers like the A1CNOW series for both home and professional use, as well as the DRX HBA1C for prescription-based home testing. The OSTEOMARK NTX line provides point-of-care and direct-response tests for osteocalcin levels, while DRX QT. HCG and INVIEW serve specific diagnostic applications in clinical settings.

Metrika’s devices are classified under Class I and Class II regulatory categories in the U.S. and are listed via FDA 510(k) clearance. The company operates from the United States, adhering to U.S. medical device regulations.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue11

Newest first, rows 1-11 of 11

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  • Osteomark Ntx Poc Ref K992997

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • A1CNOW For Home And Professional Use Ref K033847

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • A1CNOW For Professional Use Ref K020235

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Drx Qt. Hcg Ref K991532

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Inview Ref K051321

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Osteomark Ntx Point Of Care (Poc) Control Set Ref K991917

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Drx HBA1C - For Prescription Home Use Ref K000885

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Drx Ntx Or, Osteomark Ntx Direct Response Ref K984530

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • A1CNOW For Home Use Ref K022661

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • A1CNOW For Rx Home Use Ref K020234

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Drx HBA1C Ref K000887

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-11 of 11

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 1 recall initiated by Metrika, Inc., initiated on 2007-08-31. By recorded status: 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2007

    • 31 Aug 2007 Z-0289-2008 Unclassified (pre-2012) Terminated Incorrect Test Results: Due to manufacturing errors regarding temperature compensation factors, the device will give erroneously high results if the test is performed below 70 degrees Fahrenheit. Distribution: Nationwide including states of AK, AL, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, MA, MD, MI, MN, MS, NC, NJ, NV, NY,…
      Full distribution text Nationwide including states of AK, AL, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, MA, MD, MI, MN, MS, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and Puerto Rico.
      Submission number: K051321

Frequently asked questions

How many devices does Metrika, Inc. have in the registry?

The registry currently lists 11 devices for Metrika, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Metrika, Inc.'s devices?

Among its 11 most recently registered devices, Metrika, Inc. has devices listed in FDA 510(k) (11 devices).

What risk classes do Metrika, Inc.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Metrika, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Metrika, Inc.?

FDA recall records list 1 recall initiated by Metrika, Inc., the most recent initiated on 31 Aug 2007. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Metrika, Inc. in the registry?

The most recently registered devices listed for Metrika, Inc. include OSTEOMARK NTX POC, A1CNOW FOR HOME AND PROFESSIONAL USE, A1CNOW FOR PROFESSIONAL USE and DRX QT. HCG.

Generated automatically from registry data and not verified by a human reviewer.