(76 days)
No
The device description focuses on the chemical composition and preparation of calibrators and controls for drug testing, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is a calibrator and control for drug of abuse assays, used to verify the accuracy of diagnostic tests, not to treat a condition.
No
The device is a calibrator and control for drug abuse assays, not a diagnostic device itself. Its purpose is to ensure the accuracy of other diagnostic tests by providing known drug concentrations.
No
The device description clearly indicates the device is a physical substance (calibrators and controls) containing drug mixtures in human urine, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the calibrator and control set are designed for the "qualitative calibration" and "assayed control" of Roche assays for drugs of abuse in human urine. This indicates that the device is used to perform tests on biological samples (human urine) to obtain information about a person's health status (presence of drugs of abuse).
- Device Description: The description details the composition of the calibrators and controls, which are mixtures of drugs prepared in drug-free human urine. This further confirms that the device is intended for use with human biological specimens.
- Function: The device functions as a calibrator and control for assays that determine the presence of drugs of abuse. Calibrators and controls are essential components of in vitro diagnostic test systems, used to ensure the accuracy and reliability of the test results.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While detecting drugs of abuse isn't strictly a "diagnosis of disease," it falls under the broader scope of determining the "state of health" and can be used in various clinical and forensic settings.
Therefore, based on the provided information, this device clearly fits the description of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DKB, DIF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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) |
1
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)
. . . . .
2
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 |
3
| 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. |
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).
4
| New Device | Predicate Device | |||
|---|---|---|---|---|
| Item | C.f.a.s. DAT | |||
| Qualitative Plus | ||||
| Clinical | Preciset DAT | |||
| Plus I | ||||
| Calibrators | Preciset DAT | |||
| Plus II | Cfas DAT | |||
| Qualitative Plus | ||||
| Calibrators | ||||
| Intended | ||||
| Use | Same | Designed 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. | 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 |
| Matrix | Same | Human urine | ||
| based | Human urine | |||
| based | Human urine | |||
| based | ||||
| Number of | ||||
| 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 |
| 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 (Δ9 THC-COOH) | ||
| Cocaine (benzoylecgonine) |
·
·
5
| | | 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 |
・
、
:
:
· .
.
:
6
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).
7
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
8
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