(71 days)
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Not Found
No
The summary describes a calibrator for a diagnostic assay, which is a chemical reagent used for calibration, not a software or hardware device that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or data sets that would indicate the presence of such technology.
No
The device is described as a calibrator for a diagnostic assay and is intended for in vitro diagnostic use, not for treating a condition or disease.
Yes
The "Intended Use / Indications for Use" states, "This product is to be used in a diagnostic laboratory setting...It is intended for in vitro diagnostic use only." This clearly indicates it functions as a diagnostic device.
No
The summary describes a physical calibrator for a laboratory assay, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "It is intended for in vitro diagnostic use only."
- Device Description: The name "autoHDL™ Cholesterol Calibrator" suggests it's used in a diagnostic test.
- Intended User/Care Setting: Specifies use in a "diagnostic laboratory setting, by qualified laboratory technologists."
All of these points clearly indicate that the device is intended to be used outside of the body to examine specimens for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the calibration of Pointe Scientific's autoHDL™ Cholesterol assay in serum or plasma. It is intended for in vitro diagnostic use only.
Product codes
JIS
Device Description
autoHDL™ Cholesterol Calibrator
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
diagnostic laboratory setting, by qualified laboratory technologists
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)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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 with three bars representing the agency's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 3 1997
William F. Walters, Jr. · Vice President of Technical Operations Pointe Scientific, Inc. ... ...... 1025 John A. Papalas Drive Lincoln Park, Michigan 48146
K970933 Re : autoHDL™ Cholesterol Calibrator Regulatory Class: II Product Code: JIS Dated: March 10, 1997 Received: March 13, 1997
Dear Mr. Walters:
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 regulations 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 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 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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Page 1 of 1
510 (k) Number (if known):__Unknown at this time
Device Name: autoHDLTM Cholesterol Calibrator
Indications for use: ---------------------------------------------------------------------------------------------------------------------------------------------------------
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the calibration of Pointe Scientific's autoHDL™ Cholesterol assay in serum or plasma. It is intended for in vitro diagnostic use only.
ifedsonty
(Division
Division Laboratory Devices
510(k) Number: K970933
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use__
(Per 21 CFR 801.109)
or
Over-The-Counter Use -----------
(Optional Format 1-2-96)