(76 days)
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.
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). 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.
The provided text is a 510(k) summary for the C.f.a.s. DAT Qualitative Plus Clinical and Control Set DAT Clinical devices. It establishes substantial equivalence to previously marketed predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics.
Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, training set details) are not applicable or not provided in this type of submission.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
This document describes calibrators and controls for drug-of-abuse testing, not a diagnostic device with performance metrics like sensitivity and specificity against a clinical condition. Therefore, there are no specific "acceptance criteria" for clinical performance in the sense of a diagnostic test, nor reported device performance in terms of clinical accuracy (e.g., sensitivity, specificity, accuracy).
Instead, the acceptance criteria for these calibrators and controls revolve around their composition, their traceability to GC/MS verification, and their intended use for calibrating and controlling Roche assays. The "performance" is implicitly that they function as intended for these purposes when used with the specified assays.
The table below summarizes the device characteristics rather than performance against acceptance criteria in a clinical study:
| Characteristic | C.f.a.s. DAT Qualitative Plus Clinical | Control Set DAT Clinical |
|---|---|---|
| Composition | Mixture of 10 drugs in drug-free human urine | Mixture of 10 drugs in drug-free human urine |
| Drugs Included | Amphetamines, Barbituates, Benzodiazepines, Cannabinoids, Cocaine, Methadone, Methaqualone, Opiates, Phencyclidine, Propoxyphene | Amphetamines, Barbituates, Benzodiazepines, Cannabinoids, Cocaine, Methadone, Methaqualone, Opiates, Phencyclidine, Propoxyphene |
| Verification Method | Gas Chromatography/Mass Spectrometry (GC/MS) | Gas Chromatography/Mass Spectrometry (GC/MS) |
| Calibrator Levels | Single level for each drug in drug mixture | N/A (controls have target concentrations) |
| Control Target Conc. | N/A | Established at ±25% of the assay cutoff |
| Intended Use | Qualitative calibration of Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers | Assayed control in Roche test system for qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) for calibrators and controls based on substantial equivalence, not a clinical study on a device's performance against a test set of patient samples. The verification of drug concentrations is done via GC/MS of the manufactured calibrator/control product itself, not on patient samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. Ground truth for the drug concentrations within the calibrators and controls is established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical method, not by human experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no human adjudication of results is involved in establishing the ground truth for these calibrators and controls. The drug concentrations are verified by GC/MS.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study or AI-related performance evaluation is relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a calibrator/control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the drug concentrations within the calibrators and controls is established by Gas Chromatography/Mass Spectrometry (GC/MS). This is a highly accurate analytical technique used to verify the precise amount of each drug or drug metabolite added to the drug-free human urine matrix.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this 510(k) submission. These are manufactured chemical reference materials, not machine learning algorithms that require training data.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for one.
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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(91) |
Control Set DAT Clinical
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| DIF | Class I | 862.3280 | Toxicology(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 forthe qualitative calibration of the Roche assays for drugs of abuse inhuman urine on automated clinical chemistry analyzers. |
|---|---|
| The Control Set DAT Clinical is for use as an assayed control in theRoche test system for qualitative and semiquantitative determinationof drugs of abuse in human urine on automated clinical chemistryanalyzers. |
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. DATQualitative PlusClinical | Preciset DATPlus ICalibrators | Preciset DATPlus II | Cfas DATQualitative PlusCalibrators |
| IntendedUse | Same | Designed for thecalibration of theRoche assays fordrugs of abusein human urineon automatedclinicalchemistryanalyzers. | Designed for thecalibration of theRoche assays fordrugs of abuse inhuman urine onautomatedclinicalchemistryanalyzers. | Designed for thecalibration of theRoche assays fordrugs of abusein human urineon automatedclinicalchemistryanalyzers. |
| Analytes | AmphetaminesBarbituatesBenzodiazepinesCannabinoidsCocaineMethadoneMethaqualoneOpiatesPhencyclidinePropoxyphene | AmphetaminesBarbituatesBenzodiazepinesCannabinoidsCocaineMethadoneOpiatesPhencyclidinePropoxyphene | BenzodiazepinesOpiates | BarbituatesBenzodiazepinesCocaineMethadoneOpiatesPhencyclidinePropoxyphene |
| Form | Same | Liquid | Liquid | Liquid |
| Traceability | Same | GC/MS | GC/MS | GC/MS |
| Matrix | Same | Human urinebased | Human urinebased | Human urinebased |
| Number ofLevels | 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 inthe Roche test system for thequalitative and semiquantitativedetermination of drugs of abuse inhuman urine on automated clinicalchemistry analyzers. |
| Analytes | Same | Amphetamines (d-methamphetamine)Barbituates (secobarbital)Benzodiazepines (nordiazepam)Cannabinoids (Δ9 THC-COOH)Cocaine (benzoylecgonine) |
·
·
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| 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 |
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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 (240) 276-0450. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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);
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
§ 862.3200 Clinical toxicology calibrator.
(a)
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.)(b)
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.