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Siemens Healthineers, Roche, Abbott Receive FDA 510(k) Clearances in January

NEW YORK ─ The US Food and Drug Administration in January granted 510(k) clearances for tests from Siemens Healthineers, Roche, and Abbott, according to the agency's website.

Siemens Healthineers obtained clearance for its Immulite, Immulite 1000, and Immulite 2000 analyzers and enzyme-labeled chemiluminescent competitive immunoassays for the quantitative measurement of cortisol in serum and to clinically assess adrenal status.

The test consists of a solid phase bead coated with polyclonal rabbit anti-cortisol antibody and alkaline phosphatase conjugated to cortisol. A patient sample and test reagent are incubated together with the coated bead for 30 minutes, and cortisol in the sample competes with enzyme-conjugated cortisol in the reagent for a limited number of antibody binding sites on the bead.

Additionally, Roche Diagnostics obtained a claim expansion for its Cobas CT/NG assay running on its Cobas 6800 and 8800 systems. The clearance expands the assay's indications for use to include oropharyngeal and anorectal swab specimens.

The test uses real-time PCR to detect Chlamydia trachomatis or Neisseria gonorrhoeae DNA in male and female urine; clinician-instructed, self-collected vaginal swab specimens collected in a clinical setting; clinician-collected vaginal swab specimens; endocervical swab specimens; oropharyngeal swab specimens; and anorectal swab specimens. The test is used to diagnose chlamydial and gonococcal disease in symptomatic and asymptomatic individuals.

Roche also got the nod for its Cobas BKV assay running on its Cobas 6800 and 8800 systems. The nucleic acid amplification test is used for the quantitation of BK virus DNA in human ethylenediaminetetraacetic acid (EDTA) plasma and urine stabilized in Roche's Cobas PCR media.

With EDTA plasma, for example, Cobas BKV is used to manage BKV in transplant patients. Serial DNA measurements can be used to indicate the need for potential treatment changes and to assess the viral response to treatment.

Further, Abbott announced in January that it got the FDA green light for its rapid handheld blood test for traumatic brain injury.