AUTO HDL CHOLESTEROL CALIBRATOR

K970933 · Pointe Scientific, Inc., · JIS · May 23, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970933
• Device Name: AUTO HDL CHOLESTEROL CALIBRATOR
• Applicant: Pointe Scientific, Inc.,
• Product Code: JIS · Clinical Chemistry
• Decision Date: May 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended 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.

Device Story

autoHDL™ Cholesterol Calibrator is an in vitro diagnostic reagent used in clinical laboratories. It serves as a reference material to calibrate the autoHDL™ Cholesterol assay, ensuring accurate measurement of cholesterol levels in patient serum or plasma samples. Operated by qualified laboratory technologists, the calibrator allows the assay system to establish a standard curve or reference point for quantitative analysis. By providing a known concentration, it enables the assay to correctly interpret patient sample signals, facilitating reliable diagnostic results for healthcare providers. This calibration process is essential for maintaining the accuracy and precision of cholesterol testing, which supports clinical decision-making regarding lipid management and cardiovascular health assessment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic calibrator for serum/plasma cholesterol assays. Liquid or lyophilized reagent formulation. Standard laboratory diagnostic reagent technology.

Indications for Use

Indicated for calibration of autoHDL™ Cholesterol assay in serum or plasma samples within a diagnostic laboratory setting by qualified technologists.

Regulatory Classification

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.)

Special Controls

*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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
MAY 23 1997
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

William F. Walters, Jr.
Vice President of Technical Operations
Pointe Scientific, Inc.
1025 John A. Papalas Drive
Lincoln Park, Michigan 48146

Re: K970933
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 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 (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 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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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: autoHDL™ 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.


(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)