510(k) Report

FDA applicant

Medical Analysis Systems, Inc.

Camarillo, CA107 decisions1978–20042 recalls

FDA records 107 decisions for Medical Analysis Systems, Inc. (Camarillo, CA) from 1978 to 2004: 107 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and DIF (Drug Mixture Control Materials). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are linked to its devices.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Medical Analysis Systems, Inc. since 2007.

Recalls per year

2in 2013

2013: 2
2007high 2 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • JJYMulti-Analyte Controls, All Kinds (Assayed)31decisions
  • DIFDrug Mixture Control Materials13decisions
  • JJWUrinalysis Controls (Assayed And Unassayed)6decisions
  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)5decisions
  • CEKBiuret (Colorimetric), Total Protein3decisions
  • JJTEnzyme Controls (Assayed And Unassayed)3decisions

Also: CIG (3), CFR (3), CDQ (2), MSJ (2), CGS (2), JIT (2).

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 0 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.

  • K960824Immunology ControlMedical Analysis Systems, Inc. · 19963cite it
  • K023928Mas UA Control Liquid Assayed Urinalysis Control, Dade Assayed Urinalysis ControlMedical Analysis Systems, Inc. · 20022cite it
  • K030942Mas Chemtrak H & Dade Moni-Trol H Liquid Assayed Chemistry ControlMedical Analysis Systems, Inc. · 20032cite it
  • K940433Doa Liquid Drugs of Abuse Controls Levls 2,3,& 4,G2,G3,& G4Medical Analysis Systems, Inc. · 19941cites it
  • K935062Mas Liquid Urinalysis ControlMedical Analysis Systems, Inc. · 19941cites it
  • K954322Tri-Point Liquimmune Liquid Assayed Immunoassay ControlMedical Analysis Systems, Inc. · 19951cites it

What has FDA decided for it lately?

  • K042717Mas, Dade and Liquid Assayed Diabetes ControlMedical Analysis Systems, Inc. · 2004
  • K041194Abbott Architect Stat Troponin I Liquid Assayed Cardiac Marker Control Level L, M and HMedical Analysis Systems, Inc. · 2004
  • K040880Mas Cardioimmune TL Liquid Assayed Cardiac Marker Control, Levels 1,2 and 3Medical Analysis Systems, Inc. · 2004
  • K032826Mas Par TDMMedical Analysis Systems, Inc. · 2003
  • K032335Mas Cardioimmune Probnp, Mas Cardioimmune TLMedical Analysis Systems, Inc. · 2003
  • K031890Mas Bilirubin Liquid Assayed Bilirubin ControlMedical Analysis Systems, Inc. · 20031 recall
  • K031441Urichemtrak Liquid Assayed Urine ControlMedical Analysis Systems, Inc. · 2003
  • K031392Mas Tox Ammonia Controlliquid Assayed Tox Ammonia ControlMedical Analysis Systems, Inc. · 2003

All 107 as Medical Analysis Systems, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K973451MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed)…Oct 29, 2013Class III
  • K031890Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is…May 13, 2013Class II