(81 days)
Not Found
Not Found
No
The summary describes a chemistry calibrator, a standard laboratory reagent, and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is a chemistry calibrator, indicated for use in calibrating clinical chemistry assays, not for treating any medical condition.
No
Explanation: The device is described as a "calibrator" for clinical chemistry assays, which means it helps ensure the accuracy of other diagnostic tests. It does not directly diagnose a condition itself.
No
The device is described as a "Chemistry calibrator" and is intended for use with "clinical chemistry assays," which are typically hardware-based laboratory tests. The summary lacks any description of software components or functions.
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 device is a "Chemistry calibrator for use as a calibrator of Pointe Scientific, Inc. clinical chemistry assays." Calibrators are essential components used in in vitro diagnostic testing to ensure the accuracy of the results obtained from analyzing patient samples.
- Function: The device's function as a calibrator directly relates to the process of performing in vitro diagnostic tests. It provides known values to set the measurement scale for the assays.
While the "Device Description" is listed as "Not Found," the "Intended Use" is sufficient to classify this device as an IVD. IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Calibrators fall under this definition as they are necessary for the accurate performance of diagnostic tests.
N/A
Intended Use / Indications for Use
The Chemistry calibrator is for use as a calibrator of Pointe Scientific, Inc. clinical chemistry assays. The analyte constituents, set-point values and instruments are provided in the product labeling.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is 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 U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Pointe Scientific, Inc. c/o Mr. Ron Jamison, Technical Service Manager 5449 Research Drive Canton, MI 48188
APR 13 2007
Re: K070207
Trade/Device Name: Multi-Analyze Chemistry Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator, Multi-analyte mixture. Regulatory Class: Class II Product Code: JIX Dated: January 19, 2007 Received: January 30, 2007
Dear Mr. Jamison:
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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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 (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.
Jean 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
2
Indications for Use
K070207 510(k) Number (if known):
Device Name:
Multi-Analyte Chemistry Calibrator
Indications For Use:
The Chemistry calibrator is for use as a calibrator of Pointe Scientific, Inc. clinical chemistry assays. The analyte constituents, set-point values and instruments are provided in the product labeling.
Prescription Use _______________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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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Office of In Vitro Diagnostic Device
Evaluation and Safety