AMMONIA/ALCOHOL CONTROL SET

K070504 · Pointe Scientific, Inc., · JJY · Apr 11, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070504
• Device Name: AMMONIA/ALCOHOL CONTROL SET
• Applicant: Pointe Scientific, Inc.,
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 11, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Pointe Scientific, Inc. Ammonia/ Alcohol Control Set is to be used for monitoring the accuracy and precision of various ammonia and/ or ethanol assay methods and to validate quantitation of patient samples. The controls contain components of known concentrations and are an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.

Device Story

Control material for ammonia and ethanol assays; supplied as two-level, ready-to-use liquid in aqueous base with ethanol, reagent-grade chemicals, and preservatives. Used in clinical laboratories to monitor accuracy/precision of test methods and validate patient sample quantitation. Provides known concentrations for daily monitoring of intralaboratory parameters. Values listed for Roche Cobas Mira Plus. Stability: 12 months unopened, 20 days opened at 2-8°C.

Clinical Evidence

No clinical data; bench testing only. The device is a quality control material intended for laboratory monitoring of assay accuracy and precision.

Technological Characteristics

Multi-analyte control solution containing known concentrations of ammonia and ethanol. Formulated for use with clinical chemistry analyzers to verify assay performance. No specific materials, energy sources, or software algorithms are involved in the control product itself.

Indications for Use

Indicated for use as a quality control material to monitor accuracy and precision of ammonia and ethanol assay methods and validate patient sample quantitation in clinical laboratory settings.

Regulatory Classification

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

POINTE SCIENTIFIC, INC. Ron Jamison 5449 Research Drive Canton, MI 48188

APR 1 1 2007

Re: k070504 Trade Name: Ammonia/Alcohol Control Set Regulation Number: 21 CFR 862.1660 Multi-Analyte Controls all Kinds (assayed and unassayed). Regulation Name: Regulatory Class: Class I Product Code: 75 JJY Dated: February 16, 2007 February 27, 2007 Received:

Dear Mr. Jamison:

We have reviewed your Section 510(k) premarket notification of intent to market the device reference 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, Cod 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 vour 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.

Sean 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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Image /page/2/Picture/0 description: The image shows the logo for Pointe Scientific, Inc. The logo features a stylized triangle made of several diagonal lines on the left. To the right of the triangle is the company name, "POINTE SCIENTIFIC, INC.", in a bold, serif font.

## Indications for Use

510(k) Number (if known): K070504

Device Name:

Ammonia / Alcohol Control Set

Indications For Use:

The Pointe Scientific, Inc. Ammonia / alcohol Control set is to be used for monitoring the accuracy and precision of various ammonia and / or ethanol assay methods and to validate quantitation of patient samples. The controls contain components of known concentrations and are an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.

Prescription Use _ V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (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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