CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500
Device Facts
| Record ID | K080183 |
|---|---|
| Device Name | CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 |
| Applicant | Roche Diagnostics Corp. |
| Product Code | DIF · Clinical Toxicology |
| Decision Date | Mar 25, 2008 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 862.3280 |
| Device Class | Class 1 |
Intended Use
The Control Set DAT I is 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 as indicated in the System Information. The Control Set DAT II is 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 as indicated in the System Information. The Control Set DAT III is 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 as indicated in the System Information. The Control Set Amphetamine 1000 is for use as an assayed control with the Roche Abuscreen OnLine assay for Amphetamines and the COBAS INTEGRA Amphetamines cobas c pack (AMPS) for the qualitative and semiquantitative determination of amphetamines in human urine on automated clinical chemistry analyzers. The Control Set Amphetamine 500 is for use as an assayed control with the Roche Abuscreen OnLine assay for Amphetamines and the COBAS INTEGRA Amphetamines cobas c pack (AMPS) for the qualitative and semiquantitative determination of amphetamines in human urine on automated clinical chemistry analyzers.
Device Story
Drug mixture control materials in human urine matrix; used to monitor accuracy and precision of Roche drug-of-abuse assays on automated clinical chemistry analyzers. Controls provided in two levels; ready-to-use; no preparation required. Donors screened negative for HBsAg, HIV-1/2, and anti-HCV. Healthcare providers use control results to verify system performance during clinical testing. Benefits include ensuring reliability of patient drug screening results.
Clinical Evidence
No clinical data. Bench testing only; stability and traceability established via GC/MS reference testing.
Technological Characteristics
Liquid, human urine-based control materials. Contains drugs/metabolites verified by GC/MS. Designed for use on automated clinical chemistry analyzers. No software or electronic components.
Indications for Use
Indicated for use as assayed quality control materials for qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers. Intended for professional prescription use.
Regulatory Classification
Identification
A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.
Predicate Devices
- TDM Control Set (K070200)
Related Devices
- K040758 — MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT · Microgenics Corp. · May 28, 2004
- K992395 — URINE DRUG SCREENING CONTROL · Seracare Technology · Aug 26, 1999
- K153474 — Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series · Biochemical Diagnostics, Inc. · Feb 23, 2016
Submission Summary (Full Text)
{0}------------------------------------------------
K080183
MAR 2 5 2008
| | <b>510(k) Summary</b> | | | | | | | | | | |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-----|--------------------|--------------------------------|---------------|---------|-----------------------|---------------------|----------------|-------------------------------------------------|
| <b>Introduction</b> | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. | | | | | | | | | | |
| <b>1) Submitter name, address, contact</b> | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>Office: (317) 521-7688<br>Fax: (317) 521-2324 | | | | | | | | | | |
| | Contact Person: Dimitris Demirtzoglou<br>Date Prepared: January 23, 2008 | | | | | | | | | | |
| <b>2) Device name</b> | Proprietary name:<br>a. Control Set DAT I<br>b. Control Set DAT II<br>c. Control Set DAT III<br>d. Control Set Amphetamine 1000<br>e. Control Set Amphetamine 500 | | | | | | | | | | |
| <b>3) Regulatory information</b> | Applicable to each of the devices. | | | | | | | | | | |
| | <table><tr><td>Product Code:</td><td>DIF</td></tr><tr><td>Product Code Name:</td><td>Drug Mixture Control Materials</td></tr><tr><td>Device Class:</td><td>Class I</td></tr><tr><td>Classification panel:</td><td>Clinical Toxicology</td></tr><tr><td>C.F.R section:</td><td>862.3280 - Clinical Toxicology Control Material</td></tr></table> | Product Code: | DIF | Product Code Name: | Drug Mixture Control Materials | Device Class: | Class I | Classification panel: | Clinical Toxicology | C.F.R section: | 862.3280 - Clinical Toxicology Control Material |
| Product Code: | DIF | | | | | | | | | | |
| Product Code Name: | Drug Mixture Control Materials | | | | | | | | | | |
| Device Class: | Class I | | | | | | | | | | |
| Classification panel: | Clinical Toxicology | | | | | | | | | | |
| C.F.R section: | 862.3280 - Clinical Toxicology Control Material | | | | | | | | | | |
| <b>4) Predicate devices</b> | We claim substantial equivalence for each of the devices to the currently marketed TDM Control Set (K070200). | | | | | | | | | | |
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#### Control Set DAT I
5) Device Description
Control Set DAT I is prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Preservative and stabilizer are added to maintain product integrity.
Control Set DAT I contains a mixture of 10 different drugs. Drug concentrations in are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff.
| Drug | Assay<br>Cutoff | Target Concentration<br>(ng/mL) | |
|--------------------------------------|-----------------|---------------------------------|----------|
| | | PreciNeg | PreciPos |
| Amphetamines (d-<br>methamphetamine) | 500 | 375 | 625 |
| Barbiturates (secobarbital) | 200 | 150 | 250 |
| Benzodiazepines<br>(nordiazepam) | 300 | 225 | 375 |
| Cannabinoids (Δ9 THC-<br>COOH) | 50 | 37.5 | 62.5 |
| Cocaine (benzoylecgonine) | 150 | 113 | 188 |
| Methadone (dl-methadone) | 300 | 225 | 375 |
| Methaqualone<br>(methaqualone) | 300 | 225 | 375 |
| Opiates (d-morphine) | 2000 | 1500 | 2500 |
| PCP (phencyclidine) | 25 | 18.8 | 31.3 |
| Propoxyphene<br>(propoxyphene) | 300 | 225 | 375 |
### Control Set DAT II
Control Set DAT II is prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Preservative and stabilizer are added to maintain product integrity.
Control Set DAT II contains a mixture of 4 different drugs. Drug concentrations in Control Set DAT II are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff.
| Drug | Assay<br>Cutoff | Target Concentration<br>(ng/mL) | |
|--------------------------------------|-----------------|---------------------------------|----------|
| | | PreciNeg | PreciPos |
| Amphetamines (d-<br>methamphetamine) | 300 | 225 | 375 |
| Benzodiazepines<br>(nordiazepam) | 100 | 75 | 125 |
| Cannabinoids (Δ9 THC-<br>COOH) | 20 | 15 | 25 |
| Opiates (d-morphine) | 300 | 225 | 375 |
{2}------------------------------------------------
#### 5) Device Control Set DAT III Description (continued) Control Set DAT III is prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Preservative and stabilizer are added to maintain product integrity.
Control Set DAT III contains a mixture of 4 different drugs. Drug concentrations in Control Set DAT II are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff.
| Drug | Assay<br>Cutoff | Target Concentration<br>(ng/mL) | |
|--------------------------------------|-----------------|---------------------------------|----------|
| | | PreciNeg | PreciPos |
| Amphetamines (d-<br>methamphetamine) | 1000 | 750 | 1250 |
| Benzodiazepines<br>(nordiazepam) | 200 | 150 | 250 |
| Cannabinoids (Δ9 THC-<br>COOH) | 100 | 75 | 125 |
| Cocaine (benzoylecgonine) | 300 | 225 | 375 |
#### Control Set Amphetamine 1000
Control Set Amphetamine 1000 is prepared by the quantitative addition of damphetamine to drug-free human urine. Preservative is added to maintain product integrity.
Drug concentrations in Control Set Amphetamine 1000 are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff.
| Drug | Assay<br>Cutoff | Target Concentration<br>(ng/mL) | |
|------------------|-----------------|---------------------------------|----------|
| | | PreciNeg | PreciPos |
| Amphetamines (d- | 1000 | 750 | 1250 |
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| 5) Device | Control Set Amphetamine 500 | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Description<br>(continued) | Control Set Amphetamine 500 is prepared by the quantitative addition of d-amphetamine to drug-free human urine. Preservative is added to maintain product integrity. | |
| | Drug concentrations in Control Set Amphetamine 500 are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff. | |
| Drug | Assay Cutoff | Target Concentration (ng/mL) | |
|------------------|--------------|------------------------------|----------|
| | | PreciNeg | PreciPos |
| Amphetamines (d- | 500 | 375 | 625 |
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#### 6.) Intended Control Set DAT I
Use
The Control Set DAT I is 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. This product cannot be used with the Roche Abuscreen OnLine assay for Amphetamines or the COBAS INTEGRA Amphetamines cobas c pack (AMPS). Refer to the package insert or method sheet for information regarding the controls appropriate for use with these assays.
### Control Set DAT II
The Control Set DAT II is 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. This product cannot be used with the Roche Abuscreen OnLine assay for Amphetamines or the COBAS INTEGRA Amphetamines cobas c pack (AMPS). Refer to the package insert or method sheet for information regarding the controls appropriate for use with these assays.
### Control Set DAT III
The Control Set DAT III is 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. This product cannot be used with the Roche Abuscreen OnLine assay for Amphetamines or the COBAS INTEGRA Amphetamines cobas c pack (AMPS). Refer to the package insert or method sheet for information regarding the controls appropriate for use with these assays.
### Control Set Amphetamine 1000
The Control Set Amphetamine 1000 is for use as an assayed control with the Roche Abuscreen OnLine assay for Amphetamines and the COBAS INTEGRA Amphetamines cobas c pack (AMPS) for the qualitative and semiquantitative determination of amphetamines in human urine on automated clinical chemistry analyzers.
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·
| 6.) Intended Use (continued) | <b>Control Set Amphetamine 500</b> |
|------------------------------|------------------------------------|
|------------------------------|------------------------------------|
The Control Set Amphetamine 500 is for use as an assayed control with the Roche Abuscreen OnLine assay for Amphetamines and the COBAS INTEGRA Amphetamines cobas c pack (AMPS) for the qualitative and semiquantitative determination of amphetamines in human urine on automated clinical chemistry analyzers.
| 7.) Comparison to the Predicate Device | Below the similarities and differences between the Control Set DAT I, Control Set DAT II, Control Set DAT III, Control Set Amphetamine 1000, Control Set Amphetamine 500, and its predicate device TDM Control Set (K070200) are presented. |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
*Continued on next page*
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7.) Comparison to the Predicate Device (continued)
| | New Device | Predicate Device |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Control Set DAT I | TDM Control Set |
| Intended Use | The Control Set DAT I is for use as an assayed<br>control in the Roche test system for the qualitative<br>and semiquantitative determination of drugs of<br>abuse in human urine on automated clinical<br>chemistry analyzers.<br>This product cannot be used with the Roche<br>Abuscreen OnLine assay for Amphetamines or the<br>COBAS INTEGRA Amphetamines cobas c pack<br>(AMPS). Refer to the package insert or method<br>sheet for information regarding the controls<br>appropriate for use with these assays. | The TDM Control Set is for use in quality control<br>by monitoring accuracy and precision for the<br>quantitative methods as specified in the value<br>sheet. |
| Analytes | Amphetamines (d-methamphetamine) Barbiturates (secobarbital) Benzodiazepines (nordiazepam) Cannabinoids (Δ9 THC-COOH) Cocaine (benzoylecgonine) Methadone (dl-methadone) Methaqualone (methaqualone) Opiates (d-morphine) PCP (phencyclidine) Propoxyphene (propoxyphene) | Acetaminophen Amikacin Carbamazepine Digoxin Gentamicin Lidocaine N-acetylprocainamide Phenobarbital Phenytoin Primidone Procainamide Quinidine Salicylate Theophylline Tobramycin Valproic acid Vancomycin. |
| Form | Liquid | Liquid |
| Traceability | GC/MS1 | USP Standards |
| Matrix | Human urine based | Human serum based |
| Number of<br>Levels | 2 | 3 |
'Gas Chromatography/Mass Spectrometry
{7}------------------------------------------------
7.) Comparison to the Predicate Device (continued)
| | New Device | Predicate Device |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Control Set DAT II | TDM Control Set |
| Intended Use | The Control Set DAT II is for use as an assayed<br>control in the Roche test system for the qualitative<br>and semiquantitative determination of drugs of<br>abuse in human urine on automated clinical<br>chemistry analyzers.<br>This product cannot be used with the Roche<br>Abuscreen OnLine assay for Amphetamines or the<br>COBAS INTEGRA Amphetamines cobas c pack<br>(AMPS). Refer to the package insert or method<br>sheet for information regarding the controls<br>appropriate for use with these assays. | The TDM Control Set is for use in quality control<br>by monitoring accuracy and precision for the<br>quantitative methods as specified in the value<br>sheet. |
| Analytes | Amphetamines (d-methamphetamine)Benzodiazepines (nordiazepam)Cannabinoids (Δ9 THC-COOH)Opiates (d-morphine) | AcetaminophenAmikacinCarbamazepineDigoxinGentamicinLidocaineN-acetylprocainamidePhenobarbitalPhenytoinPrimidoneProcainamideQuinidineSalicylateTheophyllineTobramycinValproic acidVancoymcin. |
| Form | Liquid | Liquid |
| Traceability | GC/MS1 | USP Standards |
| Matrix | Human urine based | Human serum based |
| Number of<br>Levels | 2 | 3 |
'Gas Chromatography/Mass Spectrometry
{8}------------------------------------------------
7.) Comparison to the Predicate Device (continued)
| | New Device | Predicate Device |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Control Set DAT III | TDM Control Set |
| Intended Use | The Control Set DAT III is for use as an assayed<br>control in the Roche test system for the qualitative<br>and semiquantitative determination of drugs of<br>abuse in human urine on automated clinical<br>chemistry analyzers.<br>This product cannot be used with the Roche<br>Abuscreen OnLine assay for Amphetamines or the<br>COBAS INTEGRA Amphetamines cobas c pack<br>(AMPS). Refer to the package insert or method<br>sheet for information regarding the controls<br>appropriate for use with these assays. | The TDM Control Set is for use in quality control<br>by monitoring accuracy and precision for the<br>quantitative methods as specified in the value<br>sheet. |
| Analytes | Amphetamines (d-methamphetamine) Benzodiazepines (nordiazepam) Cannabinoids (Δ9 THC-COOH) Cocaine (benzoylecgonine) | Acetaminophen Amikacin Carbamazepine Digoxin Gentamicin Lidocaine N-acetylprocainamide Phenobarbital Phenytoin Primidone Procainamide Quinidine Salicylate Theophylline Tobramycin Valproic acid Vancomycin. |
| Form | Liquid | Liquid |
| Traceability | GC/MS1 | USP Standards |
| Matrix | Human urine based | Human serum based |
| Number of<br>Levels | 2 | 3 |
1 Gas Chromatography/Mass Spectrometry
{9}------------------------------------------------
7.) Comparison to the Predicate Device (continued)
| | New Device | Predicate Device |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Control Set Amphetamine 1000 | TDM Control Set |
| Intended Use | The Control Set Amphetamine 1000 is for use as<br>an assayed control with the Roche Abuscreen<br>OnLine assay for Amphetamines and the COBAS<br>INTEGRA Amphetamines cobas c pack (AMPS)<br>for the qualitative and semiquantitative<br>determination of amphetamines in human urine on<br>automated clinical chemistry analyzers. | The TDM Control Set is for use in quality control<br>by monitoring accuracy and precision for the<br>quantitative methods as specified in the value<br>sheet. |
| Analytes | • Amphetamines (d-amphetamine) | • Acetaminophen<br>• Amikacin<br>• Carbamazepine<br>• Digoxin<br>• Gentamicin<br>• Lidocaine<br>• N-acetylprocainamide<br>• Phenobarbital<br>• Phenytoin<br>• Primidone<br>• Procainamide<br>• Quinidine<br>• Salicylate<br>• Theophylline<br>• Tobramycin<br>• Valproic acid<br>• Vancomycin. |
| Form | Liquid | Liquid |
| Traceability | GC/MS1 | USP Standards |
| Matrix | Human urine based | Human serum based |
| Number of<br>Levels | 2 | 3 |
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
'Gas Chromatography/Mass Spectrometry
.
{10}------------------------------------------------
7.) Comparison to the Predicate Device (continued)
| | New Device | Predicate Device |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Control Set Amphetamine 500 | TDM Control Set |
| Intended Use | The Control Set Amphetamine 500 is for use as an<br>assayed control with the Roche Abuscreen OnLine<br>assay for Amphetamines and the COBAS<br>INTEGRA Amphetamines cobas c pack (AMPS)<br>for the qualitative and semiquantitative<br>determination of amphetamines in human urine on<br>automated clinical chemistry analyzers. | The TDM Control Set is for use in quality control<br>by monitoring accuracy and precision for the<br>quantitative methods as specified in the value<br>sheet. |
| Analytes | Amphetamines (d-amphetamine) | Acetaminophen Amikacin Carbamazepine Digoxin Gentamicin Lidocaine N-acetylprocainamide Phenobarbital Phenytoin Primidone Procainamide Quinidine Salicylate Theophylline Tobramycin Valproic acid Vancomycin. |
| Form | Liquid | Liquid |
| Traceability | GC/MS1 | USP Standards |
| Matrix | Human urine based | Human serum based |
| Number of<br>Levels | 2 | 3 |
- Gas Chromatography/Mass Spectrometry
{11}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Roche Diagnostics Corp. c/o Mr. Dimitris Demirtzoglou Regulatory Affairs Consultant 9115 Hague Road, P.O. Box 50416 Indianapolis. IN 46250
MAR 2 5 2008
k080183 Re:
Trade Name: Control Set Dat I, Control Set Dat II, Control Set Dat III, Control Set Amphetamine 1000, Control Set Amphetamine 500 Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I, reserved Product Codes: DIF Dated: January 23, 2008 Received: January 25, 2008
Dear Mr. Demirtzoglou:
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); 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.v.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{13}------------------------------------------------
### Indication for Use
#### 510(k) Number (if known): k080183
Device Name: Control Set DAT I, Control Set DAT II, Control Set DAT III, Control Set Amphetamine 1000, Control Set Amphetamine 500
Indication For Use:
The Control Set DAT I is 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 as indicated in the System Information.
The Control Set DAT II is 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 as indicated in the System Information.
The Control Set DAT III is 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 as indicated in the System Information.
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)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k080183
{14}------------------------------------------------
None of these above named products can be used with the Roche Abuscreen OnLine assay for Amphetamines or the COBAS INTEGRA Amphetamines cobas c pack (AMPS). The package insert or method sheet for information regarding the controls has appropriate instructions for use with these assays.
The Control Set Amphetamine 1000 is for use as an assayed control with the Roche Abuscreen OnLine assay for Amphetamines and the COBAS INTEGRA Amphetamines cobas c pack (AMPS) for the qualitative and semiquantitative determination of amphetamines in human urine on automated clinical chemistry analyzers.
The Control Set Amphetamine 500 is for use as an assayed control with the Roche Abuscreen OnLine assay for Amphetamines and the COBAS INTEGRA Amphetamines cobas c pack (AMPS) for the qualitative and semiquantitative determination of amphetamines in human urine on automated clinical chemistry analyzers.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C Benam
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080183
