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OPUS hLH Controls are quality control materials intended for use in the clinical laboratory to assess or verify the performance of the OPUS hLH assay, run on the OPUS analyzers.

OPUS hLH Controls are intended for use as quality control material to monitor the accuracy and precision of the OPUS hLH assay run on the OPUS analyzers.

N Antiserum to Human Albumin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of albumin in human serum, cerebrospinal fluid and urine, used as an aid in the diagnosis of kidney and intestinal diseases.

The proposed product, N Antiserum to Human Albumin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of albumin in human serum, cerebrospinal fluid and urine. In the proposed product, proteins contained in the human serum or urine samples, form immune complexes with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.

N Antiserum to Human Transferrin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of transferrin in human serum and urine, used as an aid in the diagnosis of latent and manifest iron deficiency and iron overload, and glomerular defects.

The proposed product, N Antiserum to Human Transferrin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of transferrin in human serum and urine. In the proposed product, proteins contained in the human serum or urine samples, form immune complexes with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.

OPUS Ferritin is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of ferritin in human serum, as an aid in the diagnosis of hemochromatosis (iron overload) and iron deficiency anemia. OPUS Serum Ferritin is intended for use with the OPUS analyzers.

OPUS Ferritin is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of ferritin in human serum.

OPUS D-Dimer is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of cross-linked fibrin degradation products (XL-FDP) containing D-Dimer in human plasma, used in the diagnosis of thromboembolic events. OPUS D-Dimer is intended for use with the OPUS analyzers.

OPUS D-Dimer is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of cross-linked fibrin degradation products containing D-Dimer in human plasma.

The Von Willebrand Reagent is intended for the determination of the ristocetin cofactor activity in human plasma. Von Willebrand Reagent is used for the determination of ristocetin cofactor activity in human plasma. The determination of ristocetin cofactor activity is important in: - The diagnosis of Von Willebrand's disease. - The diagnosis of diseases characterized by changes in the ristocetin cofactor. - Pre-operative screening of haemorrhagic diatheses.

The Von Willebrand Reagent consists of lyophilized platelets and ristocetin.

OPUS Ethanol is an in vitro diagnostic thin film-based, fluorescence inhibition test for the quantitative measurement of ethanol in human serum or plasma as an aid in the diagnosis and treatment of alcohol intoxication and poisoning. OPUS Ethanol is intended for use with the OPUS analyzers.

OPUS Ethanol is a set of in vitro diagnostic reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of ethanol in human serum or plasma. Assay range is 10-300 mg/dl.

The Emit® II Opiates 300/2000 Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analysis of opiates in human urine.

The Emit® II Opiates 300/2000 Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff, The Emit® II Opiates 300/2000 Assay has been found to be substantially equivalent to the predicate device: Emit® II Opiate Assay (K902577) with regard to intended use, assay sample, and overall performance characteristics.

The Emit® Calibrator B Level 1 and Calibrator B Level 2 are used in the calibration of the Emite d.a.u.™ Amphetamine Class, Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/ml cutoff), Cocaine Metabolite (150 ng/mL cutoff), Methadone, Methaqualone, and Propoxyphen. A caws. The Emit Calibrator B Level 1 and Calibrator B Level 2 are also used in the calibration of the Emite II Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/mL cutoff), Methadone, Methaquelone, Opiates 300/2000, and Propoxyphene Assays.

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990. Behring Diagnostics Inc. is submitting this Premarket Notification, 510(k) to convey our intention to manufacture for commercial distribution a modified Emit® Calibrator B Level 1 (cutoff) and a modified Emit® Calibrator B Level 2 (high) used in the calibration of the Emit® d.a.u. ™ Amphetamine Class, Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/mL cutoff), Cocaine Metabolite (150 ng/mL cutoff), Methadone, Methaqualone, and Propoxyphene Assays. Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high) are also used in the calibration of the Emit® II Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/mL cutoff), Methadone, Methaqualone, Opiates 300/2000, and Propoxyphene Assays. The modified Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high) are substantially equivalent to the currently marketed Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high) (K912729) with regard to intended use and overall performance characteristics. The most significant difference between the modified Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high) is the addition of morphine at 2000 ng/mL in the Calibrator B Level 1 (cutoff) and morphine at 4000 ng/mL in the Calibrator B Level 2 (high). The modified Calibrators B contain the following drug concentrations: | | Level 1<br>(ng/mL) | Level 2<br>(ng/mL) | |-----------------|--------------------|--------------------| | Benzoylecgonine | 150 | 3000 | | d-Amphetamine | 300 | 2000 | | Methadone | 300 | 1000 | | Methaqualone | 300 | 1500 | | Morphine | 2000 | 4000 | | Oxazepam | 300 | 1000 | | Propoxyphene | 300 | 1000 | | Secobarbital | 300 | 1000 |

OPUS PSA is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of prostate specific antigen (PSA) in serum. OPUS PSA is an adjunctive test used as an aid in the monitoring of prostate cancer patients. OPUS PSA is intended for use with the OPUS analyzers.

OPUS PSA is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of prostate specific antigen (PSA) in human serum.