(99 days)
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No
The document describes a quality control material for drug testing and does not mention any AI or ML components.
No
This device is an assayed control used to monitor the precision and accuracy of other drug testing systems, not to directly treat or diagnose patients.
No
The device is described as an "assayed control" used for "monitoring assay conditions" and "estimation of the precision of a device test system." It helps detect and monitor deviations in laboratory tests, but it does not directly diagnose a patient's medical condition. It's a quality control material for other tests.
No
The device description clearly states it is a human urine-based control with added drugs, metabolites, preservatives, and stabilizers. This indicates a physical, chemical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring assay conditions in semi-quantitative and qualitative analysis of patient urine specimens for drugs and drug metabolites." This involves testing biological samples (urine) outside of the body to provide information about a patient's health status (presence of drugs).
- Device Description: The description mentions it's prepared from "certified drug free human urine pools" and analyte levels are adjusted. This confirms it's a reagent or control used in laboratory testing.
- Summary of Performance Studies: The performance studies evaluate parameters like "Target achievement," "Open Bottle Stability," and "Close Bottle Stability," which are typical evaluations for IVD controls to ensure their reliability and performance in diagnostic assays.
- Predicate Device(s): The listed predicate devices (MAS DOA-XSE and MGC DAU Control Sets) are also IVD controls used in drug testing, further supporting the classification of this device as an IVD.
The device is a control material used in vitro (outside the body) to assess the performance of diagnostic tests for drugs in urine. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MAS® DOA Total is intended for use as an assayed control for monitoring assay conditions in semi-quantitative and qualitative analysis of patient urine specimens for drugs and drug metabolites. These controls are human urine based and are composed of d-methamphetamine, secobarbital, nitrazepam, oxazepam, buprenorphine, benzoylecgonine, cotinine, ethyl glucuronide, ethanol, LSD, methadone, EDDP, methaqualone, morphine, oxycodone, phencyclidine, propoxyphene, nortriptyline, and L-2-9-THC-COOH.
MAS® DOA Total provides 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.
Product codes
DIF
Device Description
DOA TOTAL is prepared from certified drug free human urine pools. Analyte levels are adjusted with purified drugs or drug metabolites. Preservatives and stabilizers are added to maintain product integrity.
DOA TOTAL offers levels of controls, at concentrations 25% below and 25% above the screening cutoff levels used by the United States Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA); for Amphetamines, PCP (Phencyclidine), Opiates, Cocaine and Marijuana (Cannabinoid).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
| Evaluation Parameter | Acceptance Criteria | Specification | Pass / Fail |
|---|---|---|---|
| Target achievement | Analyte concentrations meet specification | L1: Negative L2-L6: recovery difference vs. target within +/-10%, except LSD which is within +/-15% | Pass |
| Open Bottle Stability at 5°C | 30 days | L1: Negative L2-L6: recovery change within +/- 10% | Pass |
| Close Bottle Stability – Product Shelf Life (5°C) | 24 months (predicted) | L1: Negative L2-L5: recovery change within +/- 15% L6: recovery change within +/- 20% | Pass |
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3280 Clinical toxicology control material.
(a)
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.(b)
Classification. Class I (general 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.
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510K SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is: K103656
Company/Contact person
Lisa Charter Manager, Regulatory Affairs Thermo Fisher Scientific, Clinical Diagnostic Division 46360 Fremont Blvd Fremont, CA 94538 Phone: (510) 979-5142 Facsimile: (510) 979-5422 Email: Lisa.Charter@ThermoFisher.com
Date Prepared
February 10, 2011
Requlatory Declarations
| Common / Usual Name | MAS® DOA Total |
|---|---|
| Trade/ Proprietary Name | Thermo Scientific MAS® DOA Total |
| Classification Regulation | 21 CFR 862.3280 |
| Device Class | Class I |
| Device Regulation Panel | Toxicology |
| Product Code | DIF |
Intended use
MAS® DOA Total is intended for use as an assayed control for monitoring assay conditions in semi-quantitative and qualitative analysis of patient urine specimens for drugs and drug metabolites. These controls are human urine based and are composed of d-methamphetamine, secobarbital, nitrazepam, oxazepam, buprenorphine, benzoylecgonine, cotinine, ethyl glucuronide, ethanol, LSD, methadone, EDDP, methaqualone, morphine, oxycodone, phencyclidine, propoxyphene, nortriptyline, and L-2-9-THC-COOH.
MAS® DOA Total provides 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.
Legally marketed device to which equivalency is claimed
MAS® DOA Total is substantially equivalent to the previously cleared MAS DOA-XSE (K971058) and MGC DAU Control Sets: Primary, Clinical, and Select (K040758).
Description of Device
1
DOA TOTAL is prepared from certified drug free human urine pools. Analyte levels are adjusted with purified drugs or drug metabolites. Preservatives and stabilizers are added to maintain product integrity.
DOA TOTAL offers levels of controls, at concentrations 25% below and 25% above the screening cutoff levels used by the United States Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA); for Amphetamines, PCP (Phencyclidine), Opiates, Cocaine and Marijuana (Cannabinoid).
| Analyte | L1 | L2 | L3 | L4 | L5 | L6 | Concentration |
|---|---|---|---|---|---|---|---|
| d-Methamphetamine | 0 | 750 | 1250 | 375 | 625 | 2000 | ng/mL |
| Secobarbital | 0 | 225 | 375 | 150 | 250 | 1000 | ng/mL |
| Nitrazepam | 0 | 225 | 375 | 0 | 0 | 0 | ng/mL |
| Oxazepam | 0 | 0 | 0 | 150 | 250 | 1000 | ng/mL |
| Buprenorphine | 0 | 0 | 0 | 15 | 25 | 60 | ng/mL |
| Benzoylecgonine | 0 | 225 | 375 | 112 | 118 | 500 | ng/mL |
| Cotinine | 0 | 375 | 625 | 0 | 0 | 0 | ng/mL |
| ETG | 0 | 375 | 625 | 750 | 1250 | 0 | ng/mL |
| Ethanol | 0 | 15 | 25 | 40 | 70 | 300 | mg/dL |
| LSD | 0 | 0.3 | 0.7 | 0.3 | 0.7 | 2.5 | ng/mL |
| Methadone | 0 | 225 | 375 | 225 | 375 | 750 | ng/mL |
| EDDP | 0 | 75 | 125 | 750 | 1250 | 1500 | ng/mL |
| Methaqualone | 0 | 225 | 375 | 225 | 375 | 750 | ng/mL |
| Morphine | 0 | 225 | 375 | 1500 | 2500 | 750 | ng/mL |
| Oxycodone | 0 | 75 | 125 | 225 | 375 | 750 | ng/mL |
| PCP | 0 | 19 | 31 | 19 | 31 | 100 | ng/mL |
| PPX | 0 | 225 | 375 | 225 | 375 | 750 | ng/mL |
| Nortriptyline | 0 | 185 | 415 | 750 | 1250 | 0 | ng/mL |
| L-A-9-THC-COOH | 0 | 19 | 31 | 38 | 62 | 150 | ng/mL |
Summary of Clinical Testing
| Evaluation
Parameter | Acceptance
Criteria | Specification | Pass /
Fail |
|---------------------------------------------------------|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------|
| Target achievement | Analyte
concentrations
meet
specification | L1: Negative
L2-L6: recovery difference vs.
target within +/-10%, except LSD
which is within +/-15% | Pass |
| Open Bottle Stability
at 5°C | 30 days | L1: Negative
L2-L6: recovery change within +/- 10% | Pass |
| Close Bottle Stability
– Product Shelf Life
(5°C) | 24 months
(predicted) | L1: Negative
L2-L5: recovery change within +/- 15%
L6: recovery change within +/- 20% | Pass |
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Conclusion
As summarized, the MAS® DOA Total is substantially equivalent to previously cleared MAS DOA-XSE and MGC DAU Control Sets: Primary, Clinical, and Select. Substantial equivalence has been demonstrated through performance testing to verify that the device functions as intended and that design specifications have been satisfied.
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Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a stylized image of a bird or abstract human figure. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged in a circular fashion around the image. The bird or abstract human figure is located to the right of the text and is composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Microgenics Corporation Thermo Fisher Scientific, Clinical Diagnostics Division c/o Ms. Lisa Charter Manager, Regulatory Affairs 46360 Fremont Blvd. Fremont, CA 94538-6406
MAR 2 4 2011
Re: K103656
Trade Name: Thermo Scientific MAS R DOA Total Regulation Number: 21 CFR §862.3280 Regulation Name: Clinical toxicology control material. Regulatory Class: Class I, reserved Product Codes: DIF Dated: February 10, 2011 Received: February 14, 2011
Dear Ms. Charter:
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 Acts requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (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 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 mber (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
C.C.
Courtney Harper, Ph.D. 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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Indications for Use
510(k) Number (if known): K103656
Device Name: Thermo Scientific MAS® DOA Total
Indication for Use:
MAS® DOA Total is intended for use as an assayed control for monitoring assay conditions in semi-quantitative and qualitative analysis of patient urine specimens for drugs and drug metabolites. These controls are human urine based and are composed of d-methamphetamine, secobarbital, nitrazepam, buprenorphine, benzoylecgonine, cotinine, ethyl glucuronide, ethanol, LSD, methadone, EDDP, methaqualone, morphine, oxycodone, phencyclidine, propoxyphene, nortriptyline, and L-2-9-THC-COOH.
MAS® DOA Total provides 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.
Prescription Use × (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)
ARS
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103656