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. Carolina Liquid Chemistries was on the receiving end of the most recently […]
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) |
| DiaSorin Molecular | Clearance for Simplexa VZV Swab Direct assay to detect varicella-zoster virus (VZV) DNA from cutaneous + mucocutaneous swab specimens |
| DiaSorin | Clearance for Simplexa VZV Swab Direct assay for qualitative detection of varicella-zoster virus DNA + use with firm’s Liaison MDx instrument |
| Qiagen + DiaSorin | Clearance for Liaison QuantiFeron-TB Plus Test, an automated workflow and assay for latent tuberculosis detection |
| PerkinElmer | De novo premarket clearance for GSP Neonatal Creatine Kinase-MM kit for use in newborn screening for Duchenne Muscular Dystrophy |
| PerkinElmer | Clearance for GSP Neonatal Total Galactose kit for determination of total galactose concentrations in blood specimens dried on filter paper |
| Roche | De novo premarket 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 |
| 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 |
| 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 |
New CE Marks & Global Certifications
Notable European CE certifications announced during the period:
NEW CE MARKINGS IN EUROPE
| Manufacturer(s) | Product(s) |
| Roche | CE marking for Accu-Check SugarView app, a blood glucose monitor designed to help non-insulin-dependent type patients manage type 2 diabetes between doctors’ visits |
| Genematrix | CE marking for Neoplex RV-Panel A, a diagnostic kit to detect 10 major respiratory viruses |
| Nanomix | CE marking for mS1 Assay Panel and is used for simultaneous detection + quantification of lactate, procalcitonin + C-reactive protein associated with sepsis from human plasma specimens run on firm’s eLab analyzer |
| Agilent Technologies | CE-IVD marking in Europe for PD-L1 IHC 22C3 assay for head + neck squamous cell carcinoma (HNSCC), a companion diagnostic in combination with Merck’s anti-PD-1 immunotherapy pembrolizumab (Keytruda) |
| Genedrive | CE marking for Genedrive MT-RNR1 ID antibiotic-induced hearing loss test kit |
| T2 Biosystems | CE-IVD marking for T2Resistance Panel to detect genetic signatures of drug-resistant bacteria |
Other international clearances announced during the period:
| Manufacturer(s) | Country(ies) | Product(s) |
| Cytek Biosciences | China | National Medical Products Administration approval for seven Class I IVD flow cytometry reagents |
| Genetron Health | China | National Medical Products Administration approval for Genetron S5 instrument for targeted NGS based on Thermo Fisher Scientific Ion GeneStudio S5 system |
| Myriad Genetics | Japan | Ministry of Health, Labor and Welfare approval for BRACAnalysis Diagnostic System for identifying breast cancer patients with germline BRCA1 + BRCA2 mutations |
| CoSara Diagnostics (Co-Diagnostics’ joint manufacturing venture) | India | Central Drug Standard Control Organization approval for 5 different CoSara Saragene molecular test kits (for detecting tuberculosis, malaria, hepatitis B + hepatitis C viruses, + human papillomavirus) |
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