MULTI-ANALYTE CHEMISTRY CALIBRATOR

K070207 · Pointe Scientific, Inc., · JIX · Apr 13, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070207
• Device Name: MULTI-ANALYTE CHEMISTRY CALIBRATOR
• Applicant: Pointe Scientific, Inc.,
• Product Code: JIX · Clinical Chemistry
• Decision Date: Apr 13, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended 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. For prescription use. Use with automated and semi-automated chemistry analyzers

Device Story

Multi-Analyte Chemistry Calibrator; lyophilized human serum with diluent; contains constituents for Albumin, Bilirubin, BUN, Calcium, CO2, Chloride, Cholesterol, Creatinine, Glucose, Iron, Magnesium, Phosphorus, Total Protein, Triglycerides, and Uric Acid. Used in clinical laboratories to calibrate chemistry assays on automated/semi-automated analyzers. Values are lot-specific and provided in labeling. Human serum tested negative for HIV-1, HIV-2, HBsAg, and HCV. Provides standardized reference points for clinical chemistry testing; ensures accuracy of patient sample measurements.

Clinical Evidence

No clinical data. Bench testing only. Stability testing demonstrated 36-month shelf life at 2-8°C and 7-day open-vial stability (5 days for Bilirubin). Traceability established via NIST standard materials.

Technological Characteristics

Multi-analyte mixture; liquid or lyophilized form; intended for use with specific clinical chemistry analyzers as defined in product labeling. No specific materials or software algorithms described.

Indications for Use

Indicated for use as a calibrator for Pointe Scientific, Inc. clinical chemistry assays to establish set-point values for clinical laboratory testing.

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

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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 [phone]. 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 [phone] or [phone] 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

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## 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