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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JUN 1 8 2009

## 510(k) Summary: C.f.a.s. DAT Qualitative Plus Clinical and Control Set DAT Clinical

According to the requirements of 21 CFR 807.92, the following Introduction information provides sufficient detail to understand the basis for a determination of substantial equivalence.

Submitter Roche Diagnostics Name, Address, 9115 Hague Rd. Contact Indianapolis, IN 46250 317-521-3742

Contact Person: Michelle Neff

Date Prepared: April 2, 2009

Proprietary and Established Names

Proprietary names: C.f.a.s. DAT Qualitative Plus Clinical Control Set DAT Clinical

Regulatory Information C.f.a.s. DAT Qualitative Plus Clinical

| Product Code | Classification | Regulation Section | Panel |
|--------------|----------------|--------------------|--------------------|
| DKB | Class II | 862.3200 | Toxicology<br>(91) |

### Control Set DAT Clinical

| Product Code | Classification | Regulation Section | Panel |
|--------------|----------------|--------------------|--------------------|
| DIF | Class I | 862.3280 | Toxicology<br>(91) |

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Predicate Devices

### C.f.a.s. DAT Qualitative Plus Clinical

We claim substantial equivalence to the currently marketed Roche calibrators :

- Preciset DAT Plus I Calibrators (K031775) .
- Preciset DAT Plus II and Cfas DAT Qualitative Plus . Calibrators (K033306)

### Control Set DAT Clinical

We claim substantial equivalence to the currently marketed Roche controls :

- Control Set DAT I, Control Set DAT II, Control Set DAT III, . (K080183)
. . . . .

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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.

| Drug | Assay Cutoff (ng/mL) | Target Concentration (ng/mL) | |
|-----------------|----------------------|------------------------------|----------|
| | | PreciNeg | PreciPos |
| Amphetamines | 500 | 375 | 625 |
| Barbituates | 200 | 150 | 250 |
| Benzodiazepines | 100 | 75 | 125 |
| Cannabinoids | 50 | 37.5 | 62.5 |
| Cocaine | 300 | 225 | 375 |
| Methadone | 300 | 225 | 375 |
| Methaqualone | 300 | 225 | 375 |
| Opiates | 300 | 225 | 375 |
| Phencyclidine | 25 | 18.8 | 31.3 |
| Propoxyphene | 300 | 225 | 375 |

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

# Predicate Device

:

______________________________________________________________________________________________________________________________________________________________________________

Comparison to the The recommended controls to be used with the proposed ONLINE Amphetamines II assay are the Control Set DAT I, Control Set DAT II, Control Set DAT III (K080183).

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| | New Device | Predicate Device | | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | C.f.a.s. DAT<br>Qualitative Plus<br>Clinical | Preciset DAT<br>Plus I<br>Calibrators | Preciset DAT<br>Plus II | Cfas DAT<br>Qualitative Plus<br>Calibrators |
| Intended<br>Use | Same | Designed for the<br>calibration of the<br>Roche assays for<br>drugs of abuse<br>in human urine<br>on automated<br>clinical<br>chemistry<br>analyzers. | Designed for the<br>calibration of the<br>Roche assays for<br>drugs of abuse in<br>human urine on<br>automated<br>clinical<br>chemistry<br>analyzers. | Designed for the<br>calibration of the<br>Roche assays for<br>drugs of abuse<br>in human urine<br>on automated<br>clinical<br>chemistry<br>analyzers. |
| Analytes | Amphetamines<br>Barbituates<br>Benzodiazepines<br>Cannabinoids<br>Cocaine<br>Methadone<br>Methaqualone<br>Opiates<br>Phencyclidine<br>Propoxyphene | Amphetamines<br>Barbituates<br>Benzodiazepines<br>Cannabinoids<br>Cocaine<br>Methadone<br>Opiates<br>Phencyclidine<br>Propoxyphene | Benzodiazepines<br>Opiates | Barbituates<br>Benzodiazepines<br>Cocaine<br>Methadone<br>Opiates<br>Phencyclidine<br>Propoxyphene |
| Form | Same | Liquid | Liquid | Liquid |
| Traceability | Same | GC/MS | GC/MS | GC/MS |
| Matrix | Same | Human urine<br>based | Human urine<br>based | Human urine<br>based |
| Number of<br>Levels | 1 | Up to 6 | Up to 6 | 1 |

| | New Device | 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<br>the Roche test system for the<br>qualitative and semiquantitative<br>determination of drugs of abuse in<br>human urine on automated clinical<br>chemistry analyzers. |
| Analytes | Same | Amphetamines (d-<br>methamphetamine)<br>Barbituates (secobarbital)<br>Benzodiazepines (nordiazepam)<br>Cannabinoids (Δ9 THC-COOH)<br>Cocaine (benzoylecgonine) |

·

·

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| | | Methadone (dl-methadone)<br>Methaqualone (methaqualone)<br>Opiates (d-morphine)<br>PCP (phencyclidine)<br>Propoxyphene (propoxyphene) |
|------------------|------|---------------------------------------------------------------------------------------------------------------------------------------|
| Form | Same | Liquid |
| Traceability | Same | GC/MS |
| Matrix | Same | Human urine based |
| Number of Levels | 1 | 2 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three bars representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

### JUN 18 2009

Roche Diagnostics ATTN: Ms. Michelle L. Neff 9115 Hague Road Indianapolis, IN 46250

Re: k090939

> Trade/Device Name: Roche C.F.A.S. DAT Qualitative Plus Clinical calibrator and Control Set DAT Clinical Regulation Number: 21 CFR §862.3280 Regulation Name: Clinical toxicology control material. Regulatory Class: Class II Product Code: DKB, DIF Dated: April 2, 2009 Received: April 3, 2009

Dear Ms. Neff:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page - 2

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

A.C.H.

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

### Enclosure

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### Indication for Use

510(k) Number (if known);

K090939

Device Name: C.f.a.s. DAT Qualitative Plus Clinical & Control Set DAT Clinical

Indication 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.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K090934