OSOM C. DIFFICILE TOXIN A/B TEST— 510(k) K102242

Clearance details

Applicant

Genzyme Corporation

Product code

Code LLH

Device class

Class 1

Regulation

21 CFR 866.2660

Advisory panel

Microbiology

Date received

2010-08-09

Decision date

2010-12-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Framingham, MA, US

• K193490 — SensiTox C. difficile Toxin Test2021-07-08
• K091109 — XPERT C. DIFFICILE2009-07-09
• K090239 — PROGASTRO CD ASSAY2009-04-16
• K082499 — C. DIFF QUIK CHEK COMPLETE2009-03-26
• K081920 — BD GENEOHM CDIFF ASSAY2008-12-19

• K092633 — OSOM INFLUENZA A&B TEST , MODEL PN1902009-09-25
• K080662 — GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR2008-05-15
• K063739 — SEPRAMESH, MODEL 5959-12142007-01-17
• K053066 — SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH2005-12-19
• K043035 — SEPRAGEL ENT BIORESORBABLE PACKING/STENT2005-07-11

• Z-0015-2014 — Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD.Class II·Terminated·Sekisui Diagnostics LLC·20130916

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102242.