AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR

K033860 · Wako Chemicals USA, Inc. · JIT · Apr 23, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033860
• Device Name: AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
• Applicant: Wako Chemicals USA, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Apr 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Wako Total Ketone Body Calibrators are intended to be used with the Wako Total Ketone Bodies and the Wako Autokit 3-HB test kits to establish points of reference that are used in the determination of values in the measurement of total ketone bodies and 3-HB in human serum or plasma. The calibrators are for Rx in vitro diagnostic use.

Device Story

Wako Total Ketone Body Calibrators; liquid, ready-to-use calibrators; two levels (40 μmol/L and 300 μmol/L 3-Hydroxybutyrate). Used in clinical laboratory settings with Wako Total Ketone Bodies and Wako Autokit 3-HB test kits on Wako 30R® instruments. Provides reference points for assay calibration; enables accurate quantification of ketone bodies in patient serum or plasma. Value assignment derived via molar extinction coefficient (K-factor) of NADH.

Clinical Evidence

No clinical data. Bench testing only. Real-time stability studies demonstrated that both calibrator levels remained within 1% of expected values over 15 months when stored at 10°C.

Technological Characteristics

Liquid, ready-to-use calibrators. Matrix: Goods Buffer, polyethylene glycol, sodium azide, and 3-Hydroxybutyrate. Two levels: 40 μmol/L and 300 μmol/L. Traceability established via molar extinction coefficient (K-factor) of NADH.

Indications for Use

Indicated for use as calibrators for the measurement of total ketone bodies and 3-hydroxybutyrate (3-HB) in human serum or plasma samples.

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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APR 2 3 2004

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Tonya Mallory Executive Manager Wako Chemicals, USA, Inc. 1600 Bellwood Road Richmond, VA 23237

k033860 Rc:

K035600
Trade/Device Name: Wako Total Ketone Body Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: March 26, 2004 Received: March 29, 2004

Dear Ms. Mallory:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 910(x) premainer's substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) with the enactment date of the Medical Device American of Each Drug commerce provision of this the encordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accordained while approval application (PMA). and Cosmelle Act (Act) that do not require subject to the general controls provisions of the Act. The Y ou may, utcrerore, market the act include requirements for annual registration, listing of general controls provisions of the free labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (Scc above) into entist vias major regulations affecting your device it may be subject to such additional controls. Existing may of together and to 895. In addition, FDA call be lound in Title 21, Code of Pederal regions region in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuated of a became of the requirements of the Act
that FDA has made a determination that your device complies with other requirements of the that IDA has made a decemination administered by other Federal agencies. You must of any Federal Statutes and regulations and mittered of rogistration and listing (21 comply with an the Act 3 requirements, morating moraling macines and good manufacturing practice CFR Part 807), labeling (21 OF R Patters (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) This letter with anow you to ocgin mailities of your device of your device to a legally prematics notification: "The Presults 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 you destre specific mixotion and advertising of your device, please contact the Office of or questions on the promotion and Safety at [phone]. Also, please note the In 7 th o Diagiostic Dorrios 24 reference to premarket notification" (21CFR Part 807.97). Togulation chinica, "Thoormation on your responsibilities under the Act from the r out may oounly buter general missional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, MS, DVM.
MS, DVM.

Yean M. Cooper, MS, 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:

510(K) Number (if known): K033860

Wako Total Ketone Body Calibrators Device Name:

The Wako Total Ketone Body Calibrators are intended to be used with the Wako Autokit Total The Wako Total Ketone Dodf Canadacts and inst to establish points of reference that are used in the determination of values in the measurement of total ketone bodies and 3-hydroxybutyrate in human serum or plasma.

Proprietary Name: Wako Total Ketone Body Calibrators

Established Registration Number: 1627434

Premarket Notification 510 (k) Number: K033860

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Use_ (Optional Format 1-2-96)

Division Sign-Off

Office of In Vitro Dlagnostic Device Evaluation and Safety

510(k) k033860