Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets— 510(k) K151395

Clearance details

Applicant

Immunalysis Corporation

Product code

Code DJR

Device class

Class 2

Regulation

21 CFR 862.3620

Advisory panel

Clinical Toxicology

Date received

2015-05-26

Decision date

2015-07-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Pomona, CA, US

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• Z-2140-2018 — lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test result and a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry or Liquid Chromatography/Tandem Mass Spectrometry, must be used to obtain a confirmed analytical result.Class III·Terminated·Alere San Diego Inc. DBA Immunalysis Corporation·20171128

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151395.