(13 days)
Not Found
No
The summary describes a liquid quality control system for laboratory analyzers and does not mention any AI or ML components.
No
The device is described as a quality control system for checking the precision and accuracy of analyzers, not for treating a condition or disease.
No
Explanation: The device is described as a quality control system for checking the precision and accuracy of analyzers, not for diagnosing a medical condition in a patient. It is used to ensure other diagnostic devices are functioning correctly.
No
The device description clearly states it is a "liquid, four ampoule quality control system" and consists of physical "ampoules". This indicates a physical product, not software only.
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 Qualicheck5+ is a "quality control system, for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood gases, Co-oximetry, Electrolytes, Glucose and Lactate." This describes a product used in vitro (outside the body) to evaluate the performance of diagnostic instruments that analyze biological samples.
- Device Description: It is a "liquid, four ampoule quality control system." This further supports its use as a reagent or material used in laboratory testing.
- Predicate Device: The mention of a predicate device (K961355 Multicheck™) which is also a quality control material for blood gas and electrolyte analyzers, strongly indicates that Qualicheck5+ falls under the same regulatory category, which is IVD.
The lack of information about image processing, AI/ML, anatomical site, patient age, etc., is consistent with a quality control material, which is not directly used on patients or for image analysis.
N/A
Intended Use / Indications for Use
Qualicheck 5+ is a liquid four ampoule quality control system for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood gases, Co-oximetry. Electrolytes, Glucose and Lactate.
Product codes
JJS
Device Description
Qualicheck5+ is a four level quality control system consisting of part numbers S7730, S7740, S7750 and S7760. Each level consists of 30 ampoules per box.
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
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Multicheck (K961355)
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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K980135 jj
Exhibit VII
RADIOMETER AMERICA INC.
MEDICAL DIVISION
811 SHARON DRIVE, WESTLAKE, OHIO
JAN 2 8 1998
510(k) SUMMARY SUBJECT:
- Donald L. Baker FROM: Director of Marketing and Regulatory Affairs Radiometer America, Inc. 810 Sharon Drive Westlake, Ohio 44145 (440) 871-8900, Ext. 287 or 1-800-736-0600 Fax (440) 871-2633
- January 6, 1998 DATE:
- Trade Name Qualicheck™5 + PRODUCT: Common Name - Quality Control Classification Name - Controls for Blood Gas (assayed and unassayed)
PREDICATE
Multicheck™ DEVICE:
PRODUCT
DESCRIPTION: Qualicheck5+ is a four level quality control system consisting of part numbers S7730, S7740, S7750 and S7760. Each level consists of 30 ampoules per box.
INTENDED
- Qualicheck 5+ is a liquid four ampoule quality control system for checking the precision USE: and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Cooximetry. Electrolytes, Glucose and Lactate.
TECHNOLOGICAL CHARACTERISTICS
VERSUS PREDICATE
Qualicheck5 + is technologically similar to Multicheck. DEVICE:
SUBSTANTIAL
- EQUIVALENCE: Qualicheck5+ is substantially equivalent in features and characteristics to the current Multicheck (K961355) marketed by Radiometer America Inc. The major difference is the addition of the chloride (cCL) analyte.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 8 1998
Donald L. Baker . Director of Marketing and Regulatory Affairs Radiometer America, Inc. 811 Sharon Drive Westlake, Ohio 44145-1598
K980135 Re : Qualicheck™ 5+ Requlatory Class: I Product Code: JJS Dated: January 6, 1997 Received: January 15, 1997
Dear Mr. Baker:
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 The general controls provisions of the Act 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 In addition, FDA may publish further announcements action. 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 regulations.
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Paqe 2
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 requlation (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 Gutman
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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MEDICAL DIVISION
EXHIBIT IX
510(k) NUMBER (IF KNOWN):
4980135
DEVICE NAME:
Qualicheck™5+
INDICATIONS FOR USE:
Qualicheck5+ is a liquid, four ampoule quality control system, for checking the precision and Qualicheck5+ is a liquid, four ampoule quality control system, to the capital of the more
accuracy of Radiometer and non-Radiometer analyzers for pH/Blood gases, Co-oximetry, Electrolytes, Glucose and Lactate.
980138
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K980135
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
(Concurrence of CDRH, Office' of Device Evaluation (ODE)
t Prescription Use (Per 21 CFR 801-109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)