Home / 510(k) Clearances / K233453

510(k) K233453

Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit by Life Technologies Corporation — Product Code QQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2024
Date Received
October 20, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Device Class
Class II
Regulation Number
866.3981
Review Panel
MI
Submission Type

A device to detect and identify nucleic acid targets in respiratory specimens from SARS-CoV-2 that cause COVID-19 is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 nucleic acid targets in human clinical respiratory specimens from patients suspected of COVID-19 based on signs and symptoms of respiratory infections by their healthcare providers. The device is intended to aid in the diagnosis of COVID-19 in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.

Other clearances by Life Technologies Corporation

  • K241806 — Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel (January 8, 2025)
  • K191030 — Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx G (February 21, 2020)
  • K170299 — Ion PGM Dx System (June 22, 2017)
  • K123955 — QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT (March 8, 2013)
  • K103302 — STEMPRO MSC SFM (February 18, 2011)
  • K100616 — KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 (May 20, 2010)

Other clearances for product code QQX

  • K243396 — Aptima SARS-CoV-2 Assay (February 13, 2025)
  • K240867 — cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems (February 11, 2025)
  • K242109 — Xpert® Xpress CoV-2 plus (XPRS-COV2-10) (January 15, 2025)
  • K241580 — Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-0 (December 6, 2024)
  • K230440 — Xpert® Xpress CoV-2 plus (October 13, 2023)
  • K231306 — cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems (June 1, 2023)
  • K213804 — cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems (October 22, 2022)
  • K212147 — Simplexa COVID-19 Direct (September 13, 2022)
  • K221460 — BioFire COVID-19 Test 2 (July 25, 2022)
  • K211079 — BioFire COVID-19 Test 2 (November 1, 2021)