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Roche, Ortho Clinical Diagnostics, Abbott Laboratories, Others Obtain FDA Clearances in August

NEW YORK ─ The US Food and Drug Administration granted 510(k) clearances in August for tests from Roche, Ortho Clinical Diagnostics, Abbott Laboratories, BioMérieux, and others, according to the agency's website.

Roche got the go-ahead for its Elecsys HCG Stat test, which measures human chorionic gonadotropin, or hCG, in serum and plasma for the early detection of pregnancy. The immunoassay runs on Roche's Cobas e 601 analyzer.

Swiss Precision Diagnostics also nabbed a clearance for a pregnancy test — a urine-based over-the-counter chromatographic immunoassay for the detection of hCG. The home-use Clearblue Early Digital Pregnancy Test detects pregnancy early — in some cases, six days prior to the first day of a missed period, according to documents filed with the FDA.

Atlas Link Technology obtained 510(k) clearance for three over-the-counter pregnancy detection tests — the Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), and Atlas One Step hCG Urine Pregnancy Test (Midstream). All are urine-based lateral flow immunoassays.

The FDA also green-lighted Abbott Laboratories' i-Stat Chem8+ cartridge with its i-Stat 1 System. Using arterial or venous whole blood in point-of-care or clinical laboratory settings, the cartridge and system are used to measure levels of sodium, potassium, chloride, ionized calcium, glucose, blood urea nitrogen, creatinine, hematocrit, and total carbon dioxide.

Inova Diagnostics obtained 510(k) clearance for its Aptiva Celiac Disease IgG Reagents, which use particle-based multi-analyte technology to detect anti-tissue transglutaminase IgG autoantibodies and anti-deamidated gliadin peptide IgG autoantibodies in serum. The reagents are used to diagnose celiac disease and dermatitis herpetiformis, particularly in patients with selective IgA deficiency.

The FDA granted clearance to Diazyme for use of its PLAC Test for Lp-PLA2 Activity on automated clinical chemistry analyzers. The enzyme assay uses plasma or serum samples to measure levels of Lp-PLA2, for lipoprotein-associated phospholipase A2, a biomarker of cardiovascular risk.

Ark Diagnostics got the green light for its Ark Lacosamide Assay, which runs on automated clinical chemistry analyzers. The serum-based enzyme immunoassay measures the level of lacosamide, a drug to control partial onset seizures.

The FDA also granted clearance to Ortho Clinical Diagnostics for its Vitros Chemistry Products PHBR Slides, which measure concentrations of phenobarbital in serum and plasma using the firm's automated Vitros 5600 Integrated System. The test detects the use or overdose of phenobarbital and can be used to monitor drug concentrations to ensure appropriate therapy.

Assure Tech (Hangzhou) obtained clearance for its AssureTech DOA Dipstick Screen Panel Tests, which are lateral flow immunochromatographic assays for the detection of 6-monoacetylmorphine; amphetamine; oxazepam; cocaine; marijuana; methamphetamine; morphine; oxycodone; secobarbital; buprenorphine; methylenedioxy-methamphetamine; phencyclidine; methadone; 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine; nortriptyline; and d-propoxyphene.

WHPM got the green light for its First Sign Multi-Drug Test Dip Card, a urine-based lateral flow immunochromatographic assay for the simultaneous detection of amphetamine, buprenorphine, butalbital, oxazepam, cocaine, 2-ethylidene-1,5- dimethyl-3,3-diphenylpyrrolidine, methamphetamine, methylenedioxymethamphetamine, morphine, methadone, oxycodone, phencyclidine, propoxyphene, nortriptyline, and marijuana.

BioMérieux nabbed a clearance for use of its Vitek 2 Gram Negative Piperacillin/tazobactam for antimicrobial susceptibility testing of Gram-negative bacilli using its Vitek 2 and Vitek 2 Compact systems. Piperacillin and tazobactam is a combination penicillin antibiotic for numerous bacterial infections.

The FDA granted clearance to CD Diagnostics for its Synovasure Alpha Defensin Lateral Flow Test Kit, a visually read immunochromatographic assay for the detection of the host-response proteins alpha defensins 1-3 in the synovial fluid of adults who have had a total joint replacement and are being evaluated for revision surgery.

In other regulatory news, Visby Medical obtained FDA clearance and CLIA waiver for its Sexual Health Click Test, a single-use PCR assay to detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis, and Thermo Fisher Scientific announced the clearance of its EliA SmDP-S test as an aid in the diagnosis of systemic lupus erythematosus.