510(k) Report

FDA applicant

Metrika, Inc.

Sunnyvale, CA11 decisions1999–20051 recall

FDA records 11 decisions for Metrika, Inc. (Sunnyvale, CA) from 1999 to 2005: 11 510(k) clearances. Most are in product codes LCP (Assay, Glycosylated Hemoglobin) and JFY (Enzymatic Method, Creatinine). Its devices cite 7 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Metrika, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Metrika, Inc. since 2007.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Metrika, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Metrika, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LCPAssay, Glycosylated Hemoglobin7decisions
  • JFYEnzymatic Method, Creatinine1decision
  • JMMColumn Chromatography & Color Development, Hydroxyproline1decision
  • JJWUrinalysis Controls (Assayed And Unassayed)1decision
  • DHASystem, Test, Human Chorionic Gonadotropin1decision

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K020234A1CNOW for RX Home UseMetrika, Inc. · 20021cites it
  • K051321InviewMetrika, Inc. · 20051cites it
  • K033847A1CNOW for Home and Professional UseMetrika, Inc. · 20031cites it
  • K000885DRX HBA1C - for Prescription Home UseMetrika, Inc. · 20001cites it

What has FDA decided for it lately?

  • K051321InviewMetrika, Inc. · 20051 recall
  • K033847A1CNOW for Home and Professional UseMetrika, Inc. · 2003
  • K022661A1CNOW for Home UseMetrika, Inc. · 2002
  • K020234A1CNOW for RX Home UseMetrika, Inc. · 2002
  • K020235A1CNOW for Professional UseMetrika, Inc. · 2002
  • K000885DRX HBA1C - for Prescription Home UseMetrika, Inc. · 2000
  • K000887DRX HBA1CMetrika, Inc. · 2000
  • K992997Osteomark NTX PocMetrika, Inc. · 1999

All 11 as Metrika, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K051321A1CNOW+ with sampler 10-Test Kits (Product No: 3022), Metrika, Inc., Sunnyvale, CA…Aug 31, 2007