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 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:


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:


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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