(81 days)
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Not Found
No
The summary describes a quality control urine product for toxicology testing, with no mention of AI or ML technology.
No
The device is a quality control urine used to monitor the precision of laboratory toxicology testing, not to treat or diagnose a medical condition in a patient.
No
Explanation: The device is a quality control urine for monitoring the precision of laboratory urine toxicology testing procedures, not for diagnosing patients.
No
The device is described as a "Liquid control" and is intended for use as "quality control urine". This indicates a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quality control urine to monitor the precision of laboratory urine toxicology testing procedures". This means it's used in vitro (outside the body) to evaluate the performance of a diagnostic test.
- Anatomical Site: The sample is "urine", which is a biological specimen collected from the body and tested in vitro.
- Intended User / Care Setting: The intended user is a "laboratory", which is where in vitro diagnostic testing is performed.
All these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Detectabuse® Liquid control is intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.
Product codes
DIF
Device Description
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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
laboratory
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.
10903 New Hampshire Avenue Silver Spring, MD 20993
Biochemical Diagnostic, Inc c/o Allen Panetz 180 Heartland Blvd. Edgewood, NY 11717
K121122 Re:
3 2012 JUL
K121122
Trade Name: Detectabuse® Liquid Control Trade Name: Dober: 21 CFR §862.3280 Regulation Number. 21 CF R 300213200 Regulatory Class: Class I, reserved Product Codes: DIF Dated: June 11, 2012 Received: June 11, 2012
Dear Mr. Panetz:
We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Section 510(K) prematics is substantially equivalent (for the
referenced above and have determined the device is substantially equivalent (for the referenced above and have determined the device Is suostantials (evices marketed in
indications for use stated in the enclosure) to legally marketed predical Device indications for use stated in the enclosure) to tegality the Medical Device in the Medical Device
interstate commerce province the 1976, the enactment of the provisio interstate commerce prior to May 28, 1976, the macomen with the provisions of
Amendments, or to devices that have been recuassified in accordance with the provisions of ments, or to devices that have been reclassified in accordance with all the prematket
the Federal Food, Drug, and Cosmetic Act (Act (Act ) that do not require approval of The Federal Food, Drug, and Cosmetic Act (Act) that do not require, subject to the peneral
approval application (PMA). You may, therefore, market the device, subject to the approval application (PMA). You may, mereiols, inance institutions of the Act include
controls provisions of the Act. The general controls provisions of the Acti controls provisions of the Act. The general coldics, good manufacturing practice,
requirements for annual registration, listeading and adulteration. requirements for annual registration, noning and adulteration.
labeling, and prohibitions against misbranding and adulteration.
lf your device is classified (see above) into either class II (Special Controls) or class III
n affective and the secure and additional controls. Existing major regulations If your device is classified (see above) into existing major regulations affecting
(PMA), it may be subject to such additional controls. Existing major regulations affecting (PMA), it may be subject to such additional controls: Existilights).
your device can be found in Title 21, Code of Federal Regulations (CFR), Patts 800 to 895.
The Federal (11) 11) 11, 11, 21, Code of Federal Regulations (0) 10, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 1 Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA's issuance of a substantial equirements
mean that FDA has made a determination that your device with other requirements. I was that FDA has made a determination that your device compires.
of the Act or any Federal stations administered by other Federal agencies.
The Act of the Active Unities Ac of the Act or any Federal statutes and regulations administed or registration
You must comply with all the Act's requirements, including, but not limited to: registration
t o You must comply with all the Act's requirements, the Rates of any and only, medical device
and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809; and go and listing (21 CFR Part 807); labeling (21 CFR Parts 601 and 809); and good
reporting (reporting of medical device-related adverse events) (21 CFR 803); and good and interest of medical device-related adverse evenis) (21 UFF 000), and 1880
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you users 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 proase note the regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) Onnec of Dar vinance and garding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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 Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
N
Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use Form
510(k) Number (if known): _ K121122_
Device Name: Detectabuse® Liquid Control
Indications for Use:
The Detectabuse® Liquid control is intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Prescription Use X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121122
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