FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval
Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA’s enforcement priority list this year. The agency has issued seven warning letters related to premarket approval in 2019 after issuing just one such warning letter in all of 2018.
Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA’s enforcement priority list this year. The agency has issued seven warning letters related to premarket approval in 2019 after issuing just one such warning letter in all of 2018.
Carolina Liquid Chemistries was on the receiving end of the most recently announced warning letter, which contends that the Greensboro-based firm sold Class I and II in vitro diagnostic (IVD) reagents without obtaining the necessary premarket approval. More specifically, Carolina Liquid failed to produce evidence showing that distributions of Tapentadol, Zolpidem, Spice and Fentanyl reagents branded only for forensic or research and development were restricted to appropriate research centers, law enforcement agencies or court mandated testing centers. The agency suspects that the reagents might have also been sold to pain management centers and a clinical testing laboratory for unapproved clinical testing applications. The FDA raised concerns about the sales history of Carolina Liquid reagents branded as for forensic and research use while inspecting the company’s facilities last year.
New FDA Approvals
Here’s a look at all the important new product approvals announced from mid-November through late December:
NEW FDA APPROVALS
| Manufacturer(s) | Product(s) |
| Ortho Clinical Diagnostics | Clearance for Ortho Sera suite of reagents that enabling extended antigen phenotyping for use with the Ortho Vision analyzer |
| Cleveland Diagnostics | Breakthrough device designation for blood-based prostate cancer test that evaluates structural changes to prostate-specific antigen (PSA) rather than just measuring the level of the biomarker a la traditional PSA tests |
| OraSure Technologies | Clearance for OraQuick Ebola Rapid Antigen Test, first US-approved rapid detection test for Ebola virus |
| BioMérieux | Clearance for ETest Eravacycline assay for determining antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria |
| Philips Electronics | received 510(k) clearance for Philips IntelliSite Pathology Solution (PIPS) with a modified display |
| Binding Site Group | Clearance for Human IgA liquid reagent kit for use on firm’s Spaplus turbidimetric analyzer |
| Qingdao Hightop Biotech | Clearance for Pregnancy Rapid Test to measure human chorionic gonadotropin (hCG) in early pregnancy detection |
| Bioeasy Biotechnology | Clearance for Bioeasy Marijuana Test Dip Card and Bioeasy Marijuana Test Strip lateral flow immunochromatographic assays for preliminary detection of marijuana in urine |
| Beckman Coulter | Clearance for FC 500 MPL and MCL flow cytometers to measure biological and physical properties of cells and other particles as they pass through laser beams in a single file |
| Beckman Coulter | 510(k) clearance for DxA 5000 total laboratory automation solution |
| Sekisui Diagnostics | 510(k) clearance for Acucy Influenza A&B test + CLIA waiver for use on the Acucy Reader |
| Roche | De novo premarket review pathway clearance to market Cobas vivoDx MRSA test with Cobas vivoDx System |
| Seventh Sense Biosystems | Extension of existing 510(k) clearance for Tap push-button blood collection device, Tap, for use by laypersons and wellness testing at home |
| Sight Diagnostics | 510(k) clearance for OLO finger prick blood tester |
| Personal Genome Diagnostics | Investigational Device Exemption (IDE) approval for use of its elio tissue complete assay in a Merck trial of pembrolizumab-based combination therapy |
| RightEye | Breakthrough device clearance for Parkinson’s test |
| Foundation Medicine | Clearance for FoundationOne CDx test as a companion diagnostic for alpelisib (Novartis’ Piqray) in combination with fulvestrant (AstraZeneca’s Faslodex) for treatment of postmenopausal women, and men, with hormone receptor-positive, human epidermal growth factor receptor 2-negative, PIK3CA-mutated, advanced or metastatic breast cancer |
| Qiagen + DiaSorin | Clearance for Liaison QuantiFeron-TB Plus Test, an automated workflow and assay for latent tuberculosis detection |
| DiaSorin | Clearance for Simplexa VZV Swab Direct assay for qualitative detection of varicella-zoster virus DNA + use with firm’s Liaison MDx instrument |
| BioMérieux | Clearance for received clearance for ETest Delafloxacin system |
| Beckman Coulter | Clearance for Access PCT chemiluminescent immunoassay for measuring procalcitonin levels using firm’s Access immunoassay systems |
| Beckman Coulter | Clearance for MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem |
| Siemens Healthineers | Clearance for Advia Centaur Cortisol chemiluminescent immunoassay for quantitative determination of cortisol in serum, plasma and urine, using firm’s Advia Centaur XP system |
| Siemens Healthineers | Clearance for chemiluminescent Advia Centaur CA 15-3 assay to detect cancer antigen CA 15-3 in human serum and plasma using firm’s Advia Centaur, Advia Centaur XP and Advia Centaur XPT systems |
| PerkinElmer | Clearance for GSP Neonatal Total Galactose kit for determination of total galactose concentrations in blood specimens dried on filter paper |
| Immunalysis | Clearance Carisoprodol Metabolite/Meprobamate Urine HEIA enzyme immunoassay for analysis of anxiety disorder therapy meprobamate |
| Sebia | Clearance for Capi 3 Immunotyping kit for detection and characterization of monoclonal proteins in urine and serum |
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