(24 days)
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No
The summary describes a control material for calibrating laboratory analyzers and does not mention any AI or ML components.
No
The device is described as a "Control" for "In Vitro Diagnostic Use only," intended to monitor measurements in analyzers. It does not exert any direct therapeutic effect on a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This product is for In Vitro Diagnostic Use only," indicating its diagnostic purpose.
No
The device is an In Vitro Diagnostic (IVD) control material, which is a physical substance used to verify the performance of laboratory analyzers. It is not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "This product is for In Vitro Diagnostic Use only."
- Intended Use: The intended use describes monitoring measurements of various analytes (pH, pCO2, pO2, electrolytes, glucose, lactate, BUN, creatinine) in blood gas and other analyzers. These are tests performed on biological samples in vitro (outside the body) to provide information for diagnostic purposes.
- Control Material: The description mentions it's a "Control" material used to "verify instrument performance." Control materials are a fundamental component of IVD testing to ensure the accuracy and reliability of the analytical instruments.
Therefore, all the key indicators point to this device being an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This material is intended for use to monitor the measurements of: a. pH and pCO2 and pO2 in blood gas analyzers, - b. Na, K, Cl, Li, Ca++, and Mg++ in electrolyte analyzers, and; - c. glucose, lactate, BUN and creatinine in analyzers which measure these metabolites. The Control is provided at three clinically significant levels to make possible verification of instrument performance at different points for each analyte. This product is for In Vitro Diagnostic Use only. Determination of acid-base status, and the concentrations of oxygon, carbon dioxide, electrolytes and certain critical metabolices in arterial blood is an important adjust to patient monitoring for a variety of clinical conditions. Since therapeutic regiments are often determined by the results obtained on patient samples, the instruments used to perform these measurements must meet stringent requirements for accuracy and The use of this quality control material is to confirm the precision. performance of instruments which measure critical blood analytes (i.e. electrolytes and critical metabolites) and blood gases and pH.
Product codes
JJY
Device Description
Blood Gas/Electrolyte/Glucose, Lactate, BUN, and Creatinine Control
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
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Key Metrics
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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/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 8 1997
Mr. Bruce R. Williams Executive Vice President Bionostics, Inc. 2 Craig Road Acton, Massachusetts 01720-5405
Re : K972868 Blood Gas/Electrolyte/Glucose, Lactate, BUN, and Trade Name: Creatinine Control Regulatory Class: I Product Code: JJY Dated: July 31, 1997 Received: August 4, 1997
Dear Mr. Williams:
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 reqistration, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requiation (QS) for Medical Devices: General requlation (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 Reqister. 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 Regulations.
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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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Putman
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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Page 1 of 1
510(k) Number: Not yet assigned
Blood Gas, Electrolyte, Glucose, Lactate, BUN and Device Name: Creatinine Quality Control Product
Date of Submission: 31 July 1997
INDICATIONS FOR USE:
A. INTENDED USE
This material is intended for use to monitor the measurements of: a. pH and pCO2 and pO2 in blood gas analyzers,
- b. Na, K, Cl, Li, Ca++, and Mg++ in electrolyte analyzers, and;
- c. glucose, lactate, BUN and creatinine in analyzers which measure these metabolites.
The Control is provided at three clinically significant levels to make possible verification of instrument performance at different points for each analyte.
This product is for In Vitro Diagnostic Use only.
B. Determination of acid-base status, and the concentrations of oxygon, carbon dioxide, electrolytes and certain critical metabolices in arterial blood is an important adjust to patient monitoring for a variety of clinical conditions.
Since therapeutic regiments are often determined by the results obtained on patient samples, the instruments used to perform these measurements must meet stringent requirements for accuracy and The use of this quality control material is to confirm the precision. performance of instruments which measure critical blood analytes (i.e. electrolytes and critical metabolites) and blood gases and pH.
B. Williams August 8, 1997
Bruce R. Williams
(Division Sign-Off) (Division of Clinical Labor 510(k) Number