June 2008 Clinical Laboratory News: News from the FDA

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June 2008: Volume 34, Number 6


FDA Looks to Fill 1,300 Positions


Aiming to improve efficiency and beef up its ability to review new technologies, the FDA announced a major hiring initiative that will seek to fill more than 600 new positions in 2008 and backfill 700 others. The positions will come from throughout the agency, including CBER, CDER, CDRH, and the National Center for Toxicological Research. Jobs deemed critical include medical officers, consumer safety officers, chemists, and biologists. The FDA plans to hold or participate in job fairs across the country. Information is available online.


Automated Chemistry Analyzer, Free Thyroxine Test Cleared


The FDA cleared the Dimension EXL with LM clinical chemistry system, marketed by Siemens Healthcare Diagnostics. The Dimension EXL instrument is a floor model, fully automated, microprocessor-controlled integrated system that uses prepackaged Flex reagent cartridges. The system uses photometric, turbidimetric, chemiluminescence, and integrate ion selective multisensors and can process samples in random access, batch, and stat modes.

The agency also cleared the Dimension FT4L Flex reagent cartridge for use on the Dimension EXL analyzer, as well as the LOCI Thyroid Calibrator. The FT4L Flex reagent cartridge quantitatively measures free thyroxine in human serum and plasma, and features prepackaged reagents in a plastic, eight-well cartridge. The LOCI Thyroid Calibrator has four thyroxine levels with target values of 0.8, 1.6, 4.0, and 8.4 ng/dL


FDA Clears Lithium Assay


The cassette cobas c501 Lithium test was cleared by the FDA for use on the Roche/Hitachi cobas c systems for the quantitative determination of lithium in human serum and plasma. The test offers total precision of 2.2% at 0.79 mmol/L, 1.3% at 2.43 mmol/L, 2.3% at 0.61 mmol/L, and 1.6% at 1.62 mmol/L, as well as a reportable range of 0.05–3.00 mmol/L.


Apolipoprotein B Assay Cleared


The FDA cleared the Diazyme Apolipoprotein B Assay, intended for the quantitative determination of apo B in serum. Used as an aid for assessing the risk of coronary artery disease, the test is based on the reaction of a sample containing human apo B and a specific antiserum to form an insoluble complex that is measured turbidometrically. The concentration of apo B in the sample is determined by constructing a standard curve from the absorbance of standards. The test offers a reportable range of 25.0–160 mg/dL and a total precision of 2.1–4.8%.


FDA Clears HbA1c Assay


The FDA cleared the automated Axis-Shield Diagnostics AxSYM HbA1c assay for the quantitative determination of percent HbA1c in whole blood samples on Abbott’s AxSYM instrument. To perform the test, the whole blood sample is lysed and added to a glass fiber matrix that has been coated with blocking buffer in a previous step. Hemoglobin and HbA1c analyte are captured on the glass fiber matrix by the binding reaction between the analyte and the blocking buffer, then HbA1c is quantified by measuring the amount of HbA1c analyte captured on the matrix cell.


FDA Issues Guidance on CLIA Procedures 


A new FDA guidance document, “Administrative Procedures and CLIA Categorization,” lays out the basic steps FDA takes to determine CLIA categorization of an IVD test as well as what materials and documents manufacturers need to submit to make sure their FDA review goes smoothly. The guidance does not encompass CLIA waiver applications, but it covers what companies needs to provide for a traditional or abbreviated 510(k), electronic 510(k) or PMA submission, special 510(k), tests exempt from 510(k) review, test systems that fall under the replacement reagent policy, and original PMA or PMA supplements. The guidance is available online.

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