CLN Article

News From the FDA

In This Issue...

FDA Announces Availability of Draft Guidance on Blood Glucose Monitors
The Food and Drug Administration (FDA) has released two draft guidance documents concerning blood glucose monitoring test systems (BGMSs): "Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use" and "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use." These documents contain recommendations for manufacturers when conducting performance studies and preparing premarket submissions for BGMSs intended for use by medical professionals, and self-monitoring blood glucose test systems (SMBGs) for use by laypersons, respectively. Specifically, for blood glucose monitors intended for use in professional healthcare settings, FDA proposes evaluating their performance using parameters that are distinct from those used to evaluate SMBGs.

In the past, the agency has not recommended different types of information in premarket submissions for the two kinds of blood glucose monitors. As a result, point-of-care BGMSs were evaluated for use in the lay population, and the specific issues that occur in the professional healthcare setting were never addressed.

The agency is accepting comments on both draft guidance documents until April 7, and electronic comments may be submitted online at

AACC is also interested to hear what laboratorians think about this guidance, and invites you to email comments to Vince Stine, PhD, AACC director of government affairs, at [email protected].

Nanosphere's Antibiotic-Resistant Bacteria Test Cleared
FDA has granted Nanosphere clearance for its Verigene Gram-Negative Blood Culture (BC-GN) assay, a test that rapidly identifies a broad range of gram-negative bacteria that cause bloodstream infections, as well as genetic markers that indicate their antibiotic resistance. Five of the genetic markers detected by Verigene BC-GN are identifiers of carbapenam-resistant Enterobacteriaceae, so-called superbugs that are resistant to nearly all available antibiotics.

FDA Clears BD's Staph, MRSA Assay
BD Diagnostics has received FDA clearance for the BD MAX MRSA XT assay, the company's second test for the detection of newly emerging methicillin-resistant Staphylococcus aureus (MRSA) strains with the novel mecC gene. Designed to run on the fully-automated BD MAX system, the assay uses eXTended Detection Technology to identify these new strains of MRSA, as well as a broad spectrum of SA strains including mecC and mecA dropout mutants.

Beckman Coulter Gets FDA Clearance for Pregnancy Test
FDA has cleared the Access Total βhCG (fifth IS) pregnancy test developed by Beckman Coulter Diagnostics for the Access and UniCel Immunoassay Systems. This is the first assay for the beta subunit of human chorionic gonadotropin (βhCG)—the most commonly used indicator of pregnancy—that is standardized to the highly purified World Health Organization fifth International Standard (IS) for hCG. As a part of the standardization, Beckman Coulter updated the assay's reference ranges to include additional populations such as women older than age 40 and post-menopausal women. The Access Total βhCG also features a broad dynamic range with automatic onboard dilution capability, which reduces the need for manual sample dilutions.

FDA Clears Affymetrix's Assay for Developmental Disabilities
Affymetrix received clearance from FDA for its CytoScan Dx assay for the postnatal detection of DNA copy number variants (CNV) in children referred for chromosomal testing. By analyzing the whole genome for CNVs in one assay and at high resolution, this test could help accelerate the diagnosis of childhood developmental and intellectual disabilities.

Quidel Strep Test Cleared
FDA cleared Quidel's AmpliVue Group B Strep assay, which detects group B Streptococcus (GBS) in enriched broth cultures of specimens from antepartum women. The assay comes in Quidel's handheld, disposable AmpliVue format, and uses isothermal helicase dependent amplification combined with lateral flow technology.