(19 days)
No
The document describes a control material for urinalysis testing and does not mention any AI or ML components.
No
This device is a control material for urinalysis testing, which is used to assure consistent performance of reagents and equipment, not to treat a patient.
No
This device is a control for qualitative and semi-quantitative procedures used in routine urinalysis testing, designed to assure consistent performance of reagents and equipment. It does not diagnose medical conditions.
No
The device is a control material for urinalysis testing, which is a physical substance used in a laboratory setting, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "qualitative and semi-quantitative procedures used in routine urinalysis testing" in the "clinical laboratory." Urinalysis is a common in vitro diagnostic test.
- Control Material: It is described as a "control for qualitative and semi-quantitative procedures" and a "control material." Control materials are essential components of IVD testing to ensure the accuracy and reliability of the results.
- Assay Values: The mention of "Assay values are provided for specific systems listed" further indicates its use in conjunction with diagnostic assays.
- Comparison with Expected Ranges: The purpose of comparing observations with expected ranges is a fundamental aspect of quality control in IVD testing.
The description clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease.
N/A
Intended Use / Indications for Use
MAS® / DADE® UA Control is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, and microscopic methods of routine urinalysis. UA Control may be used in conjunction with commercially available standardized systems for urine microscopic analysis.
Product codes
JJW
Device Description
MAS™ UA Control Levels 1, and 2 and DADE® UA Control Levels 1 and 2 (K021155)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are 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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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Penny M. Layman Regulatory Affairs Manager Medical Analysis Systems Inc. 5300 Adolfo Road Camarillo, CA 93012
APR 2 9 2002
Re: K021155
Trade/Device Name: MAS™ UA Control Levels 1, and 2 and DADE® UA Control Levels 1 and 2
Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, reserved Product Code: JJW Dated: April 9, 2002
Received: April 10, 2002
Dear Ms. Layman:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nothication. The I D71 incing of successification 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 and II you desire specific advice for your as to coses contact the Office of Compliance at additionally 609.10 for in This chaglestions on the promotion and advertising of your device, (301) 594-4580. Addinonary, 10. quest at (301) 594-4639. Also, please note the regulation prease conact the Orneo or Computation (21CFR 807.97). Other general entitled, "Misoranding by reference to per the Act may be obtained from the Division of Small
information on your responsibilities under the Act may 1001 - 1001 - 1607 Information on your responsionnes analy under (800) 638-2041 or (301) 443-6597 or at its ivianaractarers - 15ttp://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE FORM
510(k) Number (if known): _ KO2 1155 The MAS® UA Control Device Name: Liquid Assayed Urinalysis Control
DADE® UA Control Liquid Assayed Urinalysis Control
Indications for Use:
MAS® / DADE® UA Control is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, and microscopic methods of routine urinalysis. UA Control may be used in conjunction with commercially available standardized systems for urine microscopic analysis.
(PI.F.A.SE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| ------------------ | -- |
| (Division Sign-Off | |
|---|---|
| Division of Clinical | |
| 510(k) Number | K021155 |
(Optional Format 3-10-98)
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