Drx HBA1C - For Prescription Home Use

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K000885 ↗

FDA Product Code

LCP

Device Class

Class II

Regulation

21 CFR Part 864.7470

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Osteomark Ntx Poc

  Class I

  FDA 510(k) K992997 Active Cleared 9 Nov 1999

• A1CNOW for Home and Professional Use

  Class II

  FDA 510(k) K033847 Active Cleared 23 Dec 2003

• A1CNOW for Professional Use

  Class II

  FDA 510(k) K020235 Active Cleared 15 Feb 2002

• Drx Qt. Hcg

  Class II

  FDA 510(k) K991532 Active Cleared 17 Sep 1999

• Inview

  Class II

  FDA 510(k) K051321 Active Cleared 13 Jun 2005

• Osteomark Ntx Point of Care (Poc) Control Set

  Class I

  FDA 510(k) K991917 Active Cleared 12 Jul 1999

See all devices from Metrika, Inc. →

• What is the primary purpose of the Drx Hba1c device?

  The Drx Hba1c is a glycosylated hemoglobin assay used to measure the concentration of glycosylated hemoglobin in the blood. It is classified as a class 2 medical device under regulation number 864.7470.

• Is this device available for general purchase?

  No, the Drx Hba1c is intended specifically for prescription home use. It requires a prescription from a healthcare provider to be used.

• What is the regulatory status of this device?

  The Drx Hba1c has received FDA 510(k) clearance under the number K000885. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices.