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Heroin Detection Assay, Kidney Injury System Cleared by FDA in November

NEW YORK (360Dx) – An assay by Microgenics for detecting the presence of heroin metabolite in urine, and Astute Medical's system for aiding in assessing kidney injury were among the notable devices that received 510(k) clearance from the US Food and Drug Administration in November.

Also cleared last month were Siemens Healthineers' assays for aiding in the diagnosis of patients with multiple myeloma and amyloidosis.

Microgenics' CEDIA Heroin Metabolite Assay is a homogeneous enzyme immunoassay for the in vitro qualitative and semiquantitative determination of the presence of 6-acetylmorphine in human urine. The test has a cutoff concentration of 10 ng/mL and is intended for use by laboratories for rapid analytical screening. It can be used with a number of clinical chemistry analyzers, according to a document with the FDA.

The assay is only for obtaining a preliminary test result, and a more specific alternative chemical method must be used for confirmation, according to the document.

Astute Medical's NephroCheck Test System is intended for use in conjunction with clinical evaluation of patients who currently have, or have had within the past 24 hours, acute cardiovascular and or respiratory compromise and are in the ICU. The system is for the risk assessment of moderate or severe kidney injury within 12 hours of patient assessment, and is intended for use with patients 21 years and older.

The test is a single cartridge comprising two immunoassays for the protein biomarkers insulin-like growth factor-binding protein, and tissue-inhibitor of metalloproteinase 2 on a membrane test strip.

Siemens received clearance for its N Latex FLC kappa assay; N latex FLC lambda assay; N FLC standard SL; and N FLC Control SL1 and SL2. The two N Latex FLC assays are IVD reagents for quantitatively determining free light chains, type kappa or type lambda, in human serum, as well as EDTA plasma by particle-enhanced immunonephelometry. The assays are for use with the BN II and BN ProSpec systems from Siemens, and combined with other clinical and lab findings, the FLC measurements can aid in diagnosing multiple myeloma and amyloidosis. 

The N FLC Standard SL is for establishing reference curves for the determination of free light chains, type kappa and type lambda with the BN II and BN ProSpec instruments, while the N FLC Control SL1 and 2 products are assayed accuracy controls and precision controls for determining free light chains, type kappa and type lambda by immunonephelometry with the BN II and BN ProSpec systems.

Other products receiving FDA clearance last month were LIA Diagnostics' flushable, biodegradable pregnancy test, GenePOC's Clostridium difficile assay, and Grifols' subsidiary Progenika's blood-based alpha-1 antitrypsin (AAT) deficiency test.