Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack— 510(k) K152408

Clearance details

Applicant

Focus Diagnostics, Inc.

Product code

Code OCC

Device class

Class 2

Regulation

21 CFR 866.3980

Advisory panel

Microbiology

Date received

2015-08-25

Decision date

2015-09-21

Decision

Substantially Equivalent

Clearance type

Special

Location

Cypress, CA, US

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• K232775 — ID NOW Influenza A & B 22023-10-10
• K231017 — Panther Fusion AdV/hMPV/RV Assay2023-05-05

• K143651 — Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack2015-03-18
• K120986 — STRATIFY JCV DXSELECT2012-08-16
• K120413 — SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK2012-07-13
• K113433 — SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT2012-04-04
• DEN120008 — STRATIFY JCV(TM) ANTIBODY2012-01-20

Death

3

Malfunction

706

Total

709

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1273-2016 — Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2650, MOL1451, MOL1452, MOL1455Class II·Terminated·Focus Diagnostics Inc·20160210

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152408.