(16 days)
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No
The document describes a control material for urinalysis testing and does not mention any AI or ML components.
No
The device is a control for urinalysis testing, which is used for quality assurance in laboratory procedures, not for treating a condition.
No
The device is described as a "control for qualitative and semi-quantitative procedures used in routine urinalysis testing," which means it is used to assure the consistent performance of other reagents and equipment, rather than directly diagnosing a condition.
No
The device is described as a "control" material for urinalysis testing, which implies a physical substance used for quality control, not a software application. The description focuses on its use with reagents and equipment, further indicating a physical product.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing." Urinalysis is a type of in vitro diagnostic testing.
- Function: The device is a "control" material. Control materials are used in IVD testing to verify the performance of reagents and equipment used to analyze patient samples. This is a core function of an IVD accessory or control.
- Setting: It is intended for use in a "clinical laboratory," which is the typical setting for IVD testing.
Therefore, based on the provided information, the MAS® UA Control and DADE® UA Control are clearly intended for use in an in vitro diagnostic context as control materials.
N/A
Intended Use / Indications for Use
MAS® 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, chemical, and microscopic methods of routine urinalysis. UA Control may be used in conjunction with commercially available standardized systems for urine microscopic analysis.
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, chemical, 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
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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
Clinical 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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized abstract symbol resembling an eagle or a bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Public Health Service
Drug Administra Rockville MD 20850
FC 1 1 2002
Ms. Penny M. Layman Manager, Regulatory Affairs Medical Analysis Systems, Inc. 5300 Adolfo Road Camarillo, CA 93012
. '
Re: K023928
Trade/Device Name: MAS® UA Control and DADE® UA Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJW Dated: November 11, 2002 Received: November 25, 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 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); 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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DICATIONS FOR USE FORM
Page 1 of 1
K01,3928 510(k) Number (if known):
Device Name:
The MAS® UA Control Liquid Assayed Urinalysis Control
DADE® UA Control Liquid Assayed Urinalysis Control
Indications for Use:
MAS® 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, chemical, and microscopic methods of routine urinalysis. UA Control may be used in conjunction with commercially available standardized systems for urine microscopic analysis.
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, chemical, and microscopic methods of routine urinalysis. UA Control may be used in conjunction with commercially available standardized systems for urine microscopic analysis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Haucerpl
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number _
x Prescription Use
(Optional Format 3-10-98)