A1CNOW for Rx Home Use

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

510(k) Number

K020234 ↗

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 A1cNow for Rx Home Use device, and who is it intended for?

  The A1cNow for Rx Home Use is designed to measure glycosylated hemoglobin (HbA1c) levels in capillary whole blood, enabling patients with diabetes to monitor their long-term blood glucose control outside clinical settings. It is intended for home use by patients under prescription supervision, allowing them to self-manage their diabetes with quantitative results at their convenience.

• Is the A1cNow device single-use or reusable, and does it require special storage conditions?

  The A1cNow for Rx Home Use is a single-use, non-sterile device, meaning each test strip or unit is intended for one-time use only. It does not require special storage conditions, making it convenient for home use without additional handling requirements.

• How was the A1cNow device cleared by the FDA, and what regulatory pathway was used?

  The A1cNow for Rx Home Use was cleared via the FDA’s Special 510(k) pathway with a Substantially Equivalent (SESE) determination. The device was reviewed by the Hematology (HE) Advisory Committee in 2002 and classified as a Class II medical device under regulation 864.7470, confirming its compliance with FDA standards for in vitro diagnostic assays.

• What type of blood sample does the A1cNow device use, and is it suitable for clinical or only home monitoring?

  The A1cNow device uses capillary whole blood samples, typically obtained via a fingerstick, for HbA1c measurement. While it is primarily intended for home use by patients under prescription supervision, its quantitative results are also clinically relevant for monitoring long-term blood glucose control, bridging home and clinical monitoring needs.