(18 days)
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No
The description details a quality control material for urinalysis, which is a physical substance with known values used to verify the accuracy of laboratory tests. There is no mention of any computational or analytical capabilities that would involve AI or ML.
No.
This device is a quality control material used for monitoring laboratory urinalysis testing results, not for treating or diagnosing patients.
No
The device is a quality control material used to monitor and control the quality of laboratory urinalysis testing results, not to diagnose a condition in a patient.
No
The device description clearly states it is a "human urine based quality control material," indicating it is a physical substance, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that it is a "quality control material used in routine urinalysis testing performed in clinical laboratories." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. While this specific device is a control, it is used in conjunction with diagnostic tests.
- Device Description: The description reinforces its use as a "human urine based quality control material used in routine urinalysis testing performed in clinical laboratories."
- Intended User / Care Setting: It is intended for use by "Clinician / clinical laboratories," which are typical settings for IVD testing.
Quality control materials like this are essential components of the IVD testing process, ensuring the accuracy and reliability of the diagnostic results obtained from patient samples.
N/A
Intended Use / Indications for Use
MAS Liquid Urinalysis Control Level 1, Level 2, and Level 3 is a human urine based quality control material used in routine urinalysis testing performed in clinical laboratories, The product is formulated to contain Protein, Glucose Ketones, Bilirubin, Blood (hemoglobin), Nitrite, Urobilinogen, Leukocyte Esterase, Sodium, Potassium, Red Cells, White Cells, Crystals, Microalbumin, and Creatinine. The product insert contains assay values for these constituents as well as physical characteristics including pH, Appearance, Color, Specific Gravity, and Osmolality.
MAS Liguid Urinalysis Control Level 1, Level 2, and Level 3 is used by the Clinician as a guality control sample with known qualitative and semi-quantitative values for each of the listed constituents, physical characteristics and assay methodologies. This allows the Clinician to monitor and control the quality of the laboratory urinalysis testing results.
Product codes (comma separated list FDA assigned to the subject device)
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
Clinician; clinical laboratories
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): 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.
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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.
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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).
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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SEP 2 9 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Scot D. Kinghorn . Director, Quality and Regulatory Affairs Medical Analysis Systems, Inc. Lincoln Technology Park 542 Flynn Road Camarillo, California 93012-8058
Re : K973451 MAS Liquid Urinalysis Control Levels 1,2, and 3 Requlatory Class: I Product Code: JJW Dated: September 10, 1997 Received: September 11, 1997
Dear Mr. Kinghorn:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note:
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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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ical Analysis Systems, Inc.
bin Technology Park • 542 Flynn Road • Camarillo. CA 93012-8058
boge: (805) 987-7891 • FAX: (805) 987-6498
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10(k) Amendment · September 18, 1997 MAS Liquid Urinalysis Control Level 1, Level 2, and Level 3
10K Number: K973451 evice Name: MAS Liquid Urinalysis Control Level 1, Level 2, and Level 3
STATEMENT OF INDICATIONS FOR USE
MAS Liquid Urinalysis Control Level 1, Level 2, and Level 3 is a human urine based quality control material used in routine urinalysis testing performed in clinical laboratories, The product is formulated to contain Protein, Glucose Ketones, Bilirubin, Blood (hemoglobin), Nitrite, Urobilinogen, Leukocyte Esterase, Sodium, Potassium, Red Cells, White Cells, Crystals, Microalbumin, and Creatinine. The product insert contains assay values for these constituents as well as physical characteristics including pH, Appearance, Color, Specific Gravity, and Osmolality.
MAS Liguid Urinalysis Control Level 1, Level 2, and Level 3 is used by the Clinician as a guality control sample with known qualitative and semi-quantitative values for each of the listed constituents, physical characteristics and assay methodologies. This allows the Clinician to monitor and control the quality of the laboratory urinalysis testing results.
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K973951 |
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