NEW YORK – The US Food and Drug Administration in September granted 510(k) clearances for hematology and immunoassay analyzers, a panel for detection of infections with biological agents, and assays used to aid monitoring and treatment of cancer patients.
Abbott got four 510(K) clearances in September. In one of those clearances, the Abbott Park, Illinois-based firm received the agency's go-ahead for its Afinion 2 and Alere Afinion AS100 Analyzer instruments used for multi-assay point-of-care testing with Afinion test cartridges as well as for its Afinion HbA1c assay used for quantitative determination of glycated hemoglobin in venous and capillary whole blood as a marker of long-term metabolic control in patients with diabetes mellitus.
The firm also gained 510(k) clearance for its TBI chemiluminescent immunoassay to aid the evaluation of adults presenting with suspected mild traumatic brain injury within 12 hours of injury. The assay, designed for use on Abbott's Architect I1000SR System, provides quantitative measurement of glial fibrillary acidic protein and ubiquitin carboxyl-terminal hydrolase L1 in plasma and serum and semi-quantitative interpretation of those results.
Abbott also gained separate clearances for a pair of cartridges designed for blood tests on the firm's point-of-care I-Stat Alinity platform. The I-Stat G Cartridge with the I-Stat 1 System is used for the quantification of glucose in blood to aid in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders, while the I-Stat G3+ Cartridge with the I-Stat 1 System is used for quantification of pH, partial pressure of oxygen, and partial pressure of carbon dioxide to aid in the diagnosis, monitoring, and treatment of respiratory, metabolic, and acid-base disturbances.
T2 Biosystems got the nod for a test used to aid in the diagnosis of anthrax, tularemia, melioidosis, glanders, typhus, and plague in patients with signs and symptoms of infections with biothreat agents or risk of exposure to those agents. The Lexington, Massachusetts-based firm's T2Biohreat Panel is a qualitative, multiplex nucleic acid-based test used to detect Bacillus anthracis, Francisella tularensis, Burkholderia mallei, Burkholderia pseudomallei, Yersinia pestis, and Rickettsia prowazekii infections from K2EDTA whole blood samples.
Erlangen, Germany-based Siemens Healthineers received the green light for updated versions of its assays used to measure treatment response in patients who have epithelian ovarian cancer and to detect residual ovarian cancer in patients following first-line therapies. The firm's Immulite/Immulite 1000 OM-MA and Immulite 2000 OM-MA assays are used for the quantitative measurement of CA 125 antigen in serum and are designed for use on the Immulite, Immulite 1000, and Immulite 2000 analyzers. The updated version has a modified blocking buffer that eliminates the risk of biotin interference.
Siemens also gained 510(k) clearance for an assay to help diagnose heart failure. The Advia Centaur NT-proBNPII assay is used for quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in serum and plasma, and it is designed for use on the Advia Centaur XP system.
Beckman Coulter secured 510(k) clearance for an updated version of its immunoassay to measure thyroid antibodies to aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease. The Brea, California-based Danaher subsidiary's Access Thyroglobulin Antibody II assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative measurement of thyroglobulin antibody levels in serum and plasma. It is designed for use on Beckman Coulter's Access Immunoassay instruments.
Another Danaher business, Cepheid, gained 510(k) clearance for a real-time PCR assay used to identify group B Streptococcus infections in pregnant patients. The Sunnyvale, California-based firm's Xpert Xpress GBS is used with vaginal or rectal swab samples for intrapartum testing at term, and it is designed for use on the Cepheid GeneXpert Dx and GeneXpert Infinity analyzers.
Meanwhile, Thermo Fisher Scientific also got FDA 510(k) clearance for an assay to aid monitoring and treatment of patients with gastroentero-pancreatic neuroendocrine tumors. The Waltham, Massachusetts-based firm's Brahms CgA II Kryptor automated immunofluorescent assay is used for quantitative determination of chromogranin A concentration in serum, and it is designed for use on the firm's Brahms Kryptor Compact Plus Analyzer.
Basel, Switzerland-based Roche got 510(k) clearances for two immunoassays for the quantitative determination of thyroglobulin in serum and plasma. The Elecsys Tg II assay is used to help monitor the presence of persistent, recurrent, or metastatic disease in patients with differentiated thyroid cancer following thyroid surgery, and the Elecsys Anti-Tg assay is used to aid the detection of autoimmune thyroid diseases.
Meanwhile, Werfen subsidiary Biokit got the go-ahead for its serological assay for herpes virus infection. The Architect HSV-1 IgG is a chemiluminescent microparticle immunoassay for the qualitative detection of IgG antibodies to herpes simplex virus type 1 in serum and plasma, and it is designed for use on Abbott Laboratories' Architect I system.
Lastly, Bedford, Massachusetts-based Instrumentation Laboratory gained FDA clearance for its fully automated chemiluminescent benchtop analyzer, the ACL TOP 970 CL, as well as a pair of chemiluminescent immunoassays. The HemosIL CL Anti-Cardiolipin IgM assay and the HemosIL CL Anti- ß2 Glycoprotein-I IgM assay are used for quantitative measurement of IgM antibodies in 3.2 percent or 3.8 percent citrated plasma to aid in the diagnosis of antiphospholipid syndrome.
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