(49 days)
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No
The summary describes a control set for laboratory assays, which are standard chemical reagents used for quality control, and there is no mention of any computational or algorithmic components.
No
The device is described as an Ammonia/alcohol Control set used for monitoring the accuracy and precision of assay methods, which means it aids in diagnostic procedures by validating quantitation of patient samples, rather than directly treating a disease or condition.
No
Explanation: This device is a control set used for monitoring the accuracy and precision of ammonia and/or ethanol assay methods. While it is an "integral part of diagnostic procedures," it does not directly diagnose a condition; rather, it ensures the reliability of the tools used for diagnosis.
No
The device is a control set for laboratory assays, which are physical substances used for calibration and quality control. The description does not mention any software component.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the control set is used for "monitoring the accuracy and precision of various ammonia and / or ethanol assay methods and to validate quantitation of patient samples." This directly relates to testing samples in vitro (outside the body) to provide information for diagnostic purposes.
- Integral part of diagnostic procedures: The description states that the controls "are an integral part of diagnostic procedures." This further reinforces their role in the diagnostic process.
- Daily monitoring of control values: The use of controls for daily monitoring of accuracy and precision is a standard practice in clinical laboratories performing diagnostic tests.
While the "Device Description" is not found, the "Intended Use / Indications for Use" section provides sufficient information to classify this device as an IVD.
N/A
Intended Use / Indications for Use
The Pointe Scientific, Inc. Ammonia / alcohol Control set is to be used for monitoring the accuracy and precision of various ammonia and / or ethanol assay methods and to validate quantitation of patient samples. The controls contain components of known concentrations and are an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.
Product codes
75 JJY
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
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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 (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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
POINTE SCIENTIFIC, INC. Ron Jamison 5449 Research Drive Canton, MI 48188
APR 1 1 2007
Re: K070504 Trade Name: Ammonia/Alcohol Control Set Regulation Number: 21 CFR 862.1660 Multi-Analyte Controls all Kinds (assayed and unassayed). Regulation Name: Regulatory Class: Class I Product Code: 75 JJY Dated: February 16, 2007 February 27, 2007 Received:
Dear Mr. Jamison:
We have reviewed your Section 510(k) premarket notification of intent to market the device reference 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, Cod 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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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 vour 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 (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Sean M. Cooper, M.S., D.V.M. 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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Image /page/2/Picture/0 description: The image shows the logo for Pointe Scientific, Inc. The logo features a stylized triangle made of several diagonal lines on the left. To the right of the triangle is the company name, "POINTE SCIENTIFIC, INC.", in a bold, serif font.
Indications for Use
510(k) Number (if known): K070504
Device Name:
Ammonia / Alcohol Control Set
Indications For Use:
The Pointe Scientific, Inc. Ammonia / alcohol Control set is to be used for monitoring the accuracy and precision of various ammonia and / or ethanol assay methods and to validate quantitation of patient samples. The controls contain components of known concentrations and are an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.
Prescription Use _ V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
C
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Tice Vitro Diagnostic Device n and Safe
070504