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FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval

by | Jan 14, 2020

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 MolecularClearance for Simplexa VZV Swab Direct assay to detect varicella-zoster virus (VZV) DNA from cutaneous + mucocutaneous swab specimens
DiaSorinClearance for Simplexa VZV Swab Direct assay for qualitative detection of varicella-zoster virus DNA + use with firm’s Liaison MDx instrument
Qiagen + DiaSorinClearance for Liaison QuantiFeron-TB Plus Test, an automated workflow and assay for latent tuberculosis detection
PerkinElmerDe novo premarket clearance for GSP Neonatal Creatine Kinase-MM kit for use in newborn screening for Duchenne Muscular Dystrophy
PerkinElmerClearance for GSP Neonatal Total Galactose kit for determination of total galactose concentrations in blood specimens dried on filter paper
RocheDe novo premarket clearance to market Cobas vivoDx MRSA test with Cobas vivoDx System
Seventh Sense BiosystemsExtension of existing 510(k) clearance for Tap push-button blood collection device, Tap, for use by laypersons and wellness testing at home
Sight Diagnostics510(k) clearance for OLO finger prick blood tester
Personal Genome DiagnosticsInvestigational Device Exemption (IDE) approval for use of its elio tissue complete assay in a Merck trial of pembrolizumab-based combination therapy
RightEyeBreakthrough device clearance for Parkinson’s test
Foundation MedicineClearance 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
BioMérieuxClearance for received clearance for ETest Delafloxacin system
Beckman CoulterClearance for Access PCT chemiluminescent immunoassay for measuring procalcitonin levels using firm’s Access immunoassay systems
Beckman CoulterClearance for MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem
Siemens HealthineersClearance for Advia Centaur Cortisol chemiluminescent immunoassay for quantitative determination of cortisol in serum, plasma and urine, using firm’s Advia Centaur XP system
Siemens HealthineersClearance 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
ImmunalysisClearance Carisoprodol Metabolite/Meprobamate Urine HEIA enzyme immunoassay for analysis of anxiety disorder therapy meprobamate
SebiaClearance 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)
RocheCE 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
GenematrixCE marking for Neoplex RV-Panel A, a diagnostic kit to detect 10 major respiratory viruses
NanomixCE 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 TechnologiesCE-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)
GenedriveCE marking for Genedrive MT-RNR1 ID antibiotic-induced hearing loss test kit
T2 BiosystemsCE-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 BiosciencesChinaNational Medical Products Administration approval for seven Class I IVD flow cytometry reagents
Genetron HealthChinaNational Medical Products Administration approval for Genetron S5 instrument for targeted NGS based on Thermo Fisher Scientific Ion GeneStudio S5 system
Myriad GeneticsJapanMinistry 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)IndiaCentral 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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