WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET

K040226 · Wako Chemicals USA, Inc. · JIT · Mar 25, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040226
• Device Name: WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET
• Applicant: Wako Chemicals USA, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Mar 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Wako Prealbumin Calibrator Set is intended to be used in the Wako Prealbumin test system to establish points of reference that are to be used in determination of values in the measurement of prealbumin in human serum or plasma. The Wako Prealbumin Control Set is intended to be used in the Wako Prealbumin Test System to estimate test precision and detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

Device Story

Wako Prealbumin Calibrator Set and Control Set are liquid, ready-to-use materials derived from human serum spiked with human prealbumin. Calibrator set includes 5 levels; control set includes 2 levels. Used in clinical laboratory settings to calibrate prealbumin assays and monitor test precision/systematic analytical deviations. Calibrators establish reference points for quantitative measurement; controls verify assay performance. Traceable to CRM470 standard via internal primary standards. Values verified via replicate testing on Hitachi 917s analyzer. Supports clinical decision-making by ensuring accuracy and reliability of prealbumin test results.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via gravimetric preparation and replicate testing (n=21) on a Hitachi 917s analyzer to confirm targeted values and ranges. Real-time, open-vial stability studies support manufacturer claims.

Technological Characteristics

Materials: Human serum matrix spiked with human prealbumin. Form: Liquid, ready-to-use. Calibrator levels: 5. Control levels: 2. Traceability: Internal primary standard traceable to CRM470. Verification method: Replicate testing on Hitachi 917s analyzer.

Indications for Use

Indicated for use in clinical laboratory settings to calibrate and monitor the precision of the Wako Prealbumin Test System for measuring prealbumin levels 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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MAR 2 5 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lori Creasy Regulatory Affairs Specialist Wako Chemicals, USA, Inc. 1600 Bellwood Road Richmond, VA 23237

k040226 Re:

> Trade/Device Name: Wako Prealbumin Calibrator Set Wako Prealbumin Control Set Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, JJX Dated: January 29, 2004 Received: February 9, 2004

## Dear Ms. Creasy .:

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 http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Jean M. Cooper, MS, DVM.

Jean 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

K040226 510(k) Number (if known):

Wako Prealbumin Calibrator Set Device Name:

Indications For Use:

The Wako Prealbumin Calibrator Set is intended to be used in the Wako Prealbumin Test System to establish points of reference that are to be used in determination of values in the measurement of prealbumin in human serum or plasma.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use N/A (21 CFR 807 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)

Carol C Benson
Division Sign-Off

Division Sign-

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040226

Page 1 of *_*_

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## Indications for Use

K040226 510(k) Number (if known):

Wako Prealbumin Control Set Device Name:

Indications For Use:

The Wako Prealbumin Control Set is intended to be used in the Wako Prealbumin Test System to estimate test precision and detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ N/A (21 CFR 807 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)

Carol C Benson
Division Sign Off

Division Sign-Off

Office of in Vitro Diagnostic Device Evaluation and Safety

510(k) Koyozzb

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