PRECISET DAT PLUS I CALIBRATORS

K031775 · Roche Diagnostics Corp. · DKB · Aug 5, 2003 · Clinical Toxicology

Device Facts

• Record ID: K031775
• Device Name: PRECISET DAT PLUS I CALIBRATORS
• Applicant: Roche Diagnostics Corp.
• Product Code: DKB · Clinical Toxicology
• Decision Date: Aug 5, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Indications for Use

The Preciset DAT Plus I calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

Device Story

Preciset DAT Plus I calibrators are liquid, ready-to-use solutions used to calibrate automated clinical chemistry analyzers for drugs of abuse testing. The calibrators consist of human urine base, preservatives, and specific concentrations of drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, phencyclidine, and propoxyphene). The set includes 6 levels of calibrators. These are used by laboratory personnel in clinical settings to establish the calibration curve for Roche assays, ensuring accurate quantification of drug analytes in patient urine samples.

Clinical Evidence

No clinical data. Bench testing only. Traceability of analyte concentrations verified via GC-MS (Gas chromatography-mass spectrometry).

Technological Characteristics

Multi-analyte calibrator set; matrix: human urine with added preservatives; analytes: amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, phencyclidine, propoxyphene; form factor: liquid, multi-level bottles; intended for use on automated clinical chemistry analyzers.

Indications for Use

Indicated for the calibration of Roche drugs of abuse assays in human urine samples using automated clinical chemistry analyzers.

Regulatory Classification

Identification

A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Abuscreen OnLine Preciset DAT I multianalyte calibrators (K951595)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE TEMPLATE

A. 510(k) Number: K031775

B. Analyte: Preciset DAT Plus I Calibrators containing specific levels of drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannaboids, cocaine, methadone, opiates, phencyclidine, and propoxyphene).

C. Type of Test: N/A

D. Applicant: Roche Diagnostics

E. Proprietary and Established Names: Preciset DAT Plus I Calibrators

F. Regulatory Information:
1. Regulation section: 21 CFR 862.3200
2. Classification: Class II
3. Product Code: DKB
4. Panel: 91

G. Intended Use:
1. Indication(s) for use: The Preciset DAT Plus I calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical analyzers.
2. Special condition for use statement(s): none
3. Special instrument Requirements: none

H. Device Description: The Preciset DAT Plus I calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical analyzers. These calibrators are liquid ready to use calibrators consisting of 6 levels (Calibrators 1 – 6) and are comprised of human urine with preservatives and specific levels of drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannaboids, cocaine, methadone, opiates, phencyclidine, and propoxyphene).

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I. Substantial Equivalence Information:

1. Predicate device name(s): Abuscreen OnLine Preciset DAT I multianalyte calibrators which were later renamed Abuscreen Online Preciset DAT I without modification
2. Predicate K number(s): K951595
3. Comparison with predicate:

| DEVICE | PREDICATE |
| --- | --- |
| A. Similarities | |
| The Preciset DAT Plus I calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers | The Preciset DAT Plus I calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers |
| Liquid ready to use | Liquid ready to use |
| Human urine with added preservatives | Human urine with added preservatives |
| B. Differences | |
| Contains 6 levels of calibrators in the following concentrations – Amphetamines (0, 250, 500, 1000, 3000, 5000 ng/ml), Barbiturates (0, 100, 200, 400 ng/ml), Benzodiazepines (0, 150, 300, 600 ng/ml), Cannabis (0, 20, 50, 100, 200, 300 ng/ml), Cocaine (0, 75, 150, 300, 1000, 5000 ng/ml), Methadone (0,150,300,600, 2000 ng/ml), Opiates (0, 600, 1000, 2000, 4000, 8000 ng/ml), Phencyclidine (0, 12.5, 25.0, 50.0 ng/ml), Propoxyphene (0,150,300,600 ng/ml). | Contains 4 levels of calibrators in the following concentrations - Amphetamines (0, 500, 1000, 2000 ng/ml), Barbiturates (0, 100, 200, 400 ng/ml), Benzodiazepines (0, 50, 100, 200 ng/ml), Cocaine (0, 150, 300, 600 ng/ml), Methadone (0,150,300,600 ng/ml), Methaqualone (0, 150, 300, 600 ng/ml), Opiates (0, 150, 300, 600 ng/ml), Phencyclidine (0, 12.5, 25.0, 50.0 ng/ml), Propoxyphene (0,150,300,600 ng/ml). |

J. Standard/Guidance Document Referenced (if applicable) Guidance for Industry - Abbreviated 510(k) Submissions for InVitro Calibrators

K. Test Principle: N/A

L. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility: N/A
b. Linearity/assay reportable range: N/A

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c. Traceability (controls, calibrators, or method): Analyte concentrations in the Preciset DAT Plus I calibrator set are traceable to and verified by a primary reference method, specifically GC-MS (Gas chromatograph-mass spectrometry).

d. Detection limit (functional sensitivity: N/A

e. Analytical specificity: N/A

f. Assay cut-off: N/A

2. Comparison studies:

a. Method comparison with predicate device: N/A

b. Matrix comparison: N/A

3. Clinical studies:

a. Clinical sensitivity: N/A

b. Clinical specificity: N/A

4. Clinical cut-off: N/A

5. Expected values/Reference range: N/A

M. Conclusion: Based upon the information provided, I recommend that the Roche Preciset DAT Plus I calibrators be found substantially equivalent with similar predicate devices as defined in 21 CFR 862.3200.