FDA Watch: Agency Confirms that LOINC Coding of IVD Tests Is Voluntary

On June 15, the FDA issued a new guidance document clarifying the rules for laboratory coding of in vitro diagnostic tests. There are four key takeaways for IVD test makers and labs:

1. No Mandatory Lab Coding of Tests
Laboratory coding is voluntary, not mandatory, according to the guidance. However, the FDA recommends that test makers use the Observation Identifiers Names and Codes (LOINC) for coding IVD tests.

2. No Mandatory Lab Coding of Devices
Similarly, the FDA is recommending but not requiring inclusion of LOINC codes for IVD tests in labeling of medical devices. The agency does not intend to perform premarket review of the LOINC codes that manufacturers provide to labs or other users.

3. LOINC Codes Must Be for Test’s Approved Indications
According to the guidance document, the LOINC codes the device manufacturer provides should be consistent with the particular IVD test’s FDA-cleared or approved indications for use. Dissemination of LOINC codes suggesting an unapproved or uncleared indication may be evidence that the device is adulterated and/or misbranded.

4. LOINC Code Distribution Format Neither Required nor Recommended
While declining to recommend a specific format for distribution, the agency “acknowledges” that LOINC codes may be displayed as simple text in a table format, or in structured formats such as Java Script Object Notification (JSON) or Extensible Markup Language (XML). However, the FDA “strongly encourages” use of an FDA-recognized consensus standard, e.g., the LOINC transmission document for IVDs (LIVD) standard, for communicating or disseminating the LOINC codes provided by manufacturers or others to labs or other end users.

FDA Revises Zika Blood Testing Guidance
On July 6, the FDA issued revised guidance for testing of donated blood for Zika virus. Punchline: After initially recommending universal nucleic acid testing of individual blood donation units, the agency indicated that it will now allow pooled testing which the guidance described as more cost effective and “less burdensome" for blood establishments. However, the guidance continued, the need for individual testing may be triggered “when certain threshold conditions are present” such as an increased risk of local mosquito-borne transmission of Zika virus in a specific geographic area.

The final guidance still requires blood establishments to test all donated whole blood and blood components for Zika virus using a nucleic acid test. Since 2016 two assays have been approved under investigational new drug applications—the Cobas Zika (Roche Molecular Systems, Inc.) and the Procleix Zika Virus Assay (Grifols Diagnostic Solutions, Inc.). In May of this year, the FDA approved an additional claim for Roche’s Cobas Zika test for pooled testing of blood or plasma donations.

New FDA Approvals
A trio of Breakthrough Device designations headline the month in FDA approvals. Here are the key approvals announced during the period (which runs from the third week in June through the third week in July):


Manufacturer(s) Product(s)
Quidel 510(k) clearance for Solana Bordetella Complete Assay run on Quidel Solana system for detecting and differentiating Bordetella pertussis and Bordetella parapertussis in nasopharyngeal swabs
Roche Breakthrough Device designation for Elecsys beta-Amyloid (1-42) CSF, immunoassay for Alzheimer’s that measures beta-amyloid concentrations  
Roche Breakthrough Device designation for Elecsys Phospho-Tau (181P) CSF, immunoassay for Alzheimer’s that measures phospho-tau peptide concentrations  
Roche Clearance for expanded use of Elecsys BRAHMS PCT assay to aid in antibiotic therapy decision-making
Roche Clearance for Elecsys CA 15-3 II assay on Elecsys and Cobas e immunoassay analyzers for determining CA 15-3 in human serum and plasma to help in management of breast cancer patients
LabCorp Approval for UltraQual Multiplex PCR Assay for hepatitis C, HIV-1, HIV-2 and hepatitis B for screening donated blood plasma
Abbott Clearance for Afinion HbA1c Dx assay to help diagnose diabetes mellitus and assess patient risk of developing disease
DiaSorin Molecular Clearance extending sample type claims for its Simplexa HSV 1 & 2 Direct assay and expanding type of samples that can be tested to genital swabs and cutaneous and mucocutaneous swab samples
Ceres Nanosciences Breakthrough Device designation for Nanotrap Lyme Antigen Test System which uses the firm’s Nanotrap technology to detect Lyme infections
Hologic Clearance for Aptima Combo 2 Assay, a nucleic acid test for detection and differentiation of ribosomal RNA from Chlamydia trachomatis or Neisseria gonorrhoeae
Bio-Rad Clearance for BioPlex 2200 25-OH Vitamin D Kit, a multiplex flow competitive immunoassay to detect 25-hydroxyvitamin D in serum
Immco Diagnostics Clearance for ImmuGlo HEp-2 Elite IFA indirect immunofluorescence test to detect anti-nuclear antibodies of IgG isotype in human serum
NeuMoDx Molecular Clearance for NeuMoDx GBS Assay to Group B streptococcus DNA from enriched swabs from pregnant women
Ark Diagnostics Clearance for Ark Fentanyl Assay immunoassay used with automated clinical chemistry analyzers to detect fentanyl in human urine at cutoff concentration of 1.0 2 ng/mL
Beckman Coulter Diagnostics Clearance for Access hsTnI assay for use on Beckman Coulter’s Access 2, Dxl, and other Access immunoassay systems to detect troponin I
PerkinElmer Clearance for Euroimunn Crithidia luciliae test (CLIFT) and CLIFT sensitive immunofluorescence assays
Fujirebio Diagnostics Clearance for received clearance for use of Lumipulse G BRAHMS PCT Assay for testing on Lumipulse G1200 immunoassay platform
Grifols Clearance for Procleix Ultrio Elite combined screening test for HIV-1, hepatitis B and hepatitis C viruses + enabling HIV-2 detection
Grifols Clearance for Procleix WNV test screening serum and plasma donations for West Nile virus run on Grifols’ Procleix Panther system

New CE Marks & Global Certifications
Notable European CE certifications:


Manufacturer(s) Product(s)
Thermo Fisher Scientific CE marking for the Phadia 200 benchtop instrument to test for allergies and autoimmunity conditions
PathoFinder CE marking for RealAccurate TVMGres PCR Kit multiplex real-time PCR assay enabling simultaneous detection of Trichomonas vaginalis or Mycoplasma genitalium in urine and vaginal samples

Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
Royal Philips South Korea Ministry of Food and Drug Safety approval of Philips IntelliSite Pathology Solution for use as a diagnostic tool
MGI (subsidiary of BGI) China China FDA medical device registration certificate for two next-generation sequencers, MGISEQ-2000 and MGISEQ-200

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