NEW WAIVED TESTS

On September 7, 2005, the Food and Drug Administration (FDA) approved the Bayer

Clinitek Status Urine Chemistry Analyzer, K031947/A005, for the analytes urine

qualitative dipstick blood, urine qualitative creatinine, urine qualitative dipstick glucose,

urine qualitative dipstick ketone, urine qualitative dipstick leukocytes, urine qualitative

dipstick nitrite, urine qualitative dipstick pH, urine qualitative dipstick protein, urine

qualitative dipstick specific gravity, urine qualitative dipstick bilirubin, and urine

qualitative dipstick urobilinogen. Waived status is applicable to the test sustem and their

instruction approved by the FDA. The FDA recommended that the test system

instruction include a statement that the test is waived under CLIA.

On January 10, 2006, the FDA approved the RAC Medical Clarity FSH One Step

Menopause Test Device {Professional Use}, K041165/A002, for the analyte follicle

stimulating hormone (FSH). Waived status is applicable to the test system and their

instructions approved by the FDA. The FDA recommended that the test system

instructions include a statement that the test is waived under CLIA.

On January 10, 2006, the FDA approved the Biotechnostix, Inc. Rapid Response FSH

One Step Menopause Test Device {Professional Use}, K041165/A003, for waived

status for the analyte follicle stimulating hormone (FSH). Waived status is applicable to

the test system and their instruction approved by the FDA. The FDA recommended that

the test system instruction include a statement that the test is waived under CLIA.

On January 10, 2006, the FDA approved the First Check Multi Drug Cup 12 {OTC},

K052115, for waived status for the analytes amphetamines, benzodiazeprines,

barbiturates, cannabinoids, cocaine metabolites, MDMA, methamphetamines,

methadone, tricyclic antidepressants, opiates, oxycodone, and PCP. Waived status is

applicable to the test system and their instructions approved by the FDA. The FDA

recommended that the test system instructions include a statement that the test is waived

under CLIA.

On January 17, 2006, the FDA approved the First Check Diagnostics First Check

Multi Drug Cup, K051966/A001, for waived status for the analytes amphetamines,

cannabinoids, cocaine metabolities, MDMA, methamphetamines, opiates and

phencyclindine (PCP). Waived status is applicable to the test system instruction include

a statement that the test is waived under CLIA.

On February 17, 2006, the FDA approved the Axis-Shield Afinion AS100 Analyzer,

K050574/A001, for waived status for the analyte glycosylated hemoglobin (Hgb A1c).

Waived status is applicable to the test system and their instructions approved by the FDA.

The FDA recommended that the test system instructions include a statement that the test

is waived under CLIA.

On February 22, 2006, the FDA approved the First Check Diagnostics First Check 12

Drug Test, K052115/A003, for waived status for the analytes amphetamines,

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