ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190

K090939 · Roche Diagnostics · DKB · Jun 18, 2009 · Clinical Toxicology

Device Facts

• Record ID: K090939
• Device Name: ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190
• Applicant: Roche Diagnostics
• Product Code: DKB · Clinical Toxicology
• Decision Date: Jun 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended Use

The C.f.a.s. DAT Qualitative Plus Clinical calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. The Control Set DAT Clinical is for use as an assayed control in the Roche test system for qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers.

Device Story

Device consists of C.f.a.s. DAT Qualitative Plus Clinical calibrators and Control Set DAT Clinical controls; both are liquid, human urine-based mixtures containing 10 drugs/metabolites (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, propoxyphene). Calibrators provide single-level qualitative calibration; controls provide assayed reference points for qualitative/semiquantitative determination. Used in clinical laboratories on automated chemistry analyzers; operated by laboratory technicians. Concentrations verified via GC/MS. Output used by clinicians to validate assay performance and ensure accurate patient drug testing results; supports clinical decision-making regarding drug screening.

Clinical Evidence

No clinical data. Bench testing only. Analytical performance established via GC/MS verification of drug concentrations and stability protocols for shelf-life and open-vial use.

Technological Characteristics

Liquid-based calibrator and control materials derived from human urine. Traceable to GC/MS primary reference method. Designed for use on Roche/Hitachi and cobas c automated clinical chemistry analyzers. No electronic or software components; purely chemical/biological diagnostic reagents.

Indications for Use

Indicated for use as calibrators and assayed controls in Roche drugs of abuse test systems for human urine analysis on automated clinical chemistry analyzers. No specific patient population, age, or gender restrictions are defined.

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

• Preciset DAT Plus I Calibrators (k031775)
• Preciset DAT Plus II (k033306)
• Cfas DAT Qualitative Plus Calibrators (k080183)
• Control Set DAT I (k031775)
• Control Set DAT II (k033306)
• Control Set DAT III (k080183)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
k090939

B. Purpose for Submission:
New device

C. Measurand:
Calibrator and control for Roche/Hitachi analyzers and cobas c analyzers test system
Multiple constituents listed in the package insert

D. Type of Test:
Not applicable

E. Applicant:
Roche Diagnostics

F. Proprietary and Established Names:
C.f.a.s. DAT Qualitative Plus Clinical calibrator
Control Set DAT Clinical

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.3280, Clinical toxicology calibrator
21 CFR § 862.3200, Clinical toxicology control material
2. Classification:
Class II
Class I - reserved
3. Product code:
DKB; DIF
4. Panel:
Toxicology (91)

H. Intended Use:

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1. Intended use:

See indications for use below.

2. Indications for use:

The C.f.a.s. DAT Qualitative Plus Clinical calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

The Control Set DAT Clinical is for use as an assayed control in the Roche test system for qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers.

3. Special conditions for use statement(s):

For Prescription Use Only

4. Special instrument requirements:

For use on Roche/Hitachi analyzers and cobas c analyzers

I. Device Description:

C.f.a.s. DAT Qualitative Plus Clinical calibrators contain a mixture of 10 different drugs, prepared by quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, barbituates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, and propoxyphene. The calibrator set contains a single level for each drug in a drug mixture. Drug concentrations are verified by gas chromatography/mass spectrometry (GC/MS). Drugs or drug metabolites and their respective levels included are as follows:

Amphetamines: 500 ng/mL
Barbituates: 200 ng/mL
Benzodiazepines: 100 ng/mL
Cannabinoids: 50 ng/mL
Cocaine: 300 ng/mL
Methadone: 300 ng/mL
Methaqualone: 300 ng/mL
Opiates: 300 ng/mL
Phencyclidine: 25 ng/mL
Propoxyphene: 300 ng/mL

Control Set DAT Clinical controls contain a mixture of 10 different drugs, prepared by quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, barbituates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, and propoxyphene. Drug concentrations are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ±25% of the assay cutoff.

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Donors for the pools of human urine used in the preparation of this product all screened negative in annual serum testing for hepatitis B surface antigen (HBsAg), and for antibodies to HIV type 1, HIV type 2, and hepatitis C (anti-HCV), using FDA accepted test methods.

## J. Substantial Equivalence Information:

1. Predicate device name:
Preciset DAT Plus I Calibrators
Preciset DAT Plus II and Cfas DAT Qualitative Plus Calibrators
Control Set DAT I, Control Set DAT II, Control Set DAT III

2. Predicate 510(k) number(s):
k031775; k033306; k080183

3. Comparison with predicate:

| New Device (Calibrator) | | Predicate Device | | |
| --- | --- | --- | --- | --- |
| Item | C.f.a.s. DAT Qualitative Plus Clinical calibrator | Preciset DAT Plus I Calibrators | Preciset DAT Plus II | C.f.a.s DAT Qualitative Plus Calibrators |
| Intended Use | Same | Intended for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. | Intended for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. | Designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. |
| Analytes | Amphetamines
Barbituates
Benzodiazepines
Cannabinoids
Cocaine
Methadone
Methaqualone
Opiates
Phencyclidine
Propoxyphene | Amphetamines
Barbituates
Benzodiazepines
Cannabinoids
Cocaine
Methadone
Opiates
Phencyclidine
Propoxyphene | Benzodiazepines
Opiates | Barbituates
Benzodiazepines
Cocaine
Methadone
Opiates
Phencyclidine
Propoxyphene |
| Form | Same | Liquid | Liquid | Liquid |
| Traceability | Same | GC/MS | GC/MS | GC/MS |

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| Matrix | Same | Human urine based | Human urine based | Human urine based |
| --- | --- | --- | --- | --- |
| Number of Levels | 1 | Up to 6 | Up to 6 | 1 |
| New Device (Control) | | Predicate Device |
| --- | --- | --- |
| Item | Control Set DAT Clinical | Control Set DAT I, Control Set DAT II, Control Set DAT III |
| Intended Use | Same | For use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers. |
| Analytes | Same | Amphetamines (d-methamphetamine) Barbituates (secobarbital) Benzodiazepines (nordiazepam) Cannabinoids (Δ 9THC-COOH) Cocaine (benzoylecgonine) Methadone (dl-methadone) Methaqualone (methaqualone) Opiates (d-morphine) PCP (phencyclidine) Propoxyphene (propoxyphene) |
| Form | Same | Liquid |
| Traceability | Same | GC/MS |
| Matrix | Same | Human urine based |
| Number of Levels | 1 | 2 |

# K. Standard/Guidance Document Referenced (if applicable):

Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission

Guidance for Industry and FDA Staff - Assayed and Unassayed Quality Control Material

Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use

Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic

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Calibrators; Final

L. Test Principle:
Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Not applicable
b. Linearity/assay reportable range:
Not applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Drug concentrations in C.f.a.s. DAT Qualitative Plus Clinical calibrator were verified by gas chromatography/mass spectrometry (GC/MS).
C.f.a.s. DAT Qualitative Plus Clinical calibrator is traceable to a primary reference method (GC/MS).
Drug concentrations in Control Set DAT Clinical were verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25 % of the assay cutoff.
Control Set DAT Clinical controls is traceable to a primary reference method (GC/MS).
The protocols for establishing shelf-life and open-vial stability were reviewed and adequate.
d. Detection limit:
Not Applicable
e. Analytical specificity:
Not Applicable
f. Assay cut-off:
Not Applicable

2. Comparison studies:
a. Method comparison with predicate device:

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Not Applicable

b. Matrix comparison:
Not Applicable

3. Clinical studies:
a. Clinical Sensitivity:
Not Applicable
b. Clinical specificity:
Not Applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not Applicable

4. Clinical cut-off:
Not Applicable

5. Expected values/Reference range:
Not Applicable

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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