PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240

K040958 · Tokyo Boeki Medical System , Ltd. · JJE · Feb 15, 2005 · Clinical Chemistry

Device Facts

• Record ID: K040958
• Device Name: PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240
• Applicant: Tokyo Boeki Medical System , Ltd.
• Product Code: JJE · Clinical Chemistry
• Decision Date: Feb 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2160
• Device Class: Class 1

Intended Use

This device with an optional Ion-selective Electrode (ISE) module is a clinical chemistry analyzer intended to be used for the measurement of sodium, potassium, and chloride in serum to monitor electrolyte balance.

Device Story

Prestige 24i (also marketed as Sirrus and MGC 240) is a clinical chemistry analyzer. It utilizes an optional Ion Selective Electrode (ISE) module to measure sodium, potassium, and chloride concentrations in serum samples. The device employs indirect potentiometry for electrolyte analysis. It is intended for use in clinical laboratory settings to monitor patient electrolyte balance. The system is calibrated using known concentration calibrator material. Healthcare providers use the quantitative output to assess patient electrolyte status and inform clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Method comparison performed against predicate using 97 serum samples; correlations: Sodium (r=0.9744), Potassium (r=0.994), Chloride (r=0.985). Precision studies (within-run and day-by-day) showed CVs ranging from 0.5% to 2.5%. Interference testing confirmed no significant impact from bilirubin, lipids, or hemoglobin.

Technological Characteristics

Ion Selective Electrode (ISE) potentiometry. Measures sodium, potassium, chloride. Serum sample type. Automated sample aspiration. Barcode sample identification. Discrete, random access, multi-test analysis. Two-point calibration performed daily; one-point calibration per test. Software-controlled processing.

Indications for Use

Indicated for the measurement of sodium, potassium, and chloride in serum to monitor electrolyte balance in patients.

Regulatory Classification

Identification

A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

Predicate Devices

• Roche Cobas Mira Plus (K851172)

Submission Summary (Full Text)

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<040958
Aug 1 of 3

Tokyo Boeki Medical System Ltd.

FEB 1 5 20953, 2-chome Ninomiyahigashi Akiruno-shi Tokyo 19-0815 Japan
Short Short Collection 10-10-10-10-10-10-19 19-19-19 15-19-15 Japan Phone: [phone] Fax: [phone]

# 510(k) SUMMARY

### Submitter's Name/Address

| Submitter's Name: | Tokyo Boeki Medical System Ltd. |
|------------------------------------|-------------------------------------------------------------------|
| Submitter's Address: | 3-63, 2-chome Ninomiyahigashi<br>Akiruno-shi Tokyo 197-0815 Japan |
| Phone: | [phone] |
| Fax: | [phone] |
| Establishment Registration Number: | 3004378324 |
| Owner/Operator Number: | 9060135 |

### Contact Person (United States Agent)

| Name of Agent: | James M. Clinton |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Agent's Business Name: | Quality and Regulatory Consulting, LLC |
| Street Address: | 5304 Golden Moss Trail, Raleigh,<br>NC 27613-5662 |
| Phone: | 919-247-0479 |
| Fax: | 919-957-7911 |
| E-mail address: | [e-mail] |
| Date of Preparation of this Summary: | November 5, 2004 |
| Device Trade or Proprietary Name : | Prestige 24i, Sirrus, MGC 240<br>(These are the same models except the names.<br>For convenience of explanation, the Prestige 24i is<br>represented of the three in this summary.) |
| Device Common Name: | Clinical Chemistry Analyzer<br>(with optional ISE Module) |
| Classification Numbers/Class: | 75JJE, Class I<br>75JGS, Class II<br>75CEM, Class II<br>75CGZ, Class II<br>75JIX Class II |

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K040958

page 2 of 3

#### 510(k) Summary:

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(K) number is : ______________________________________________________________________________________________________________________________________________

#### Description:

The Prestige 24i with Ion Selective module additionally measures the concentration of the electrolytes, sodium, potassium and chloride in samples, using indirect potentiometry.

#### Substantial Equivalence:

Substantial equivalence has been demonstrated between the Roche Cobas Mira Plus (K851172) and the Prestige 24i. Both analyzers are used to analyze for electrolytes. Both analyzers are calibrated with known concentration calibrator material and both utilize Ion Selective Electrodes.

#### Intended Use:

This device with an optional Ion Selective Electrode (ISE) module is a clinical chemistry analyzer intended to be used for the measurement of sodium, potassium and chloride in samples.

#### Performance Characteristics:

A correlation analysis between Roche Cobas Mira Plus and the Prestige 24i yielded the following results :

| | Representative Method | Correlation Coefficient | Slope (Least-Squares) | Y-axis intercept |
|---|-----------------------|-------------------------|-----------------------|------------------|
| 1 | Sodium | 0.97 | 0.95 | +6.8625 mmol/L |
| 2 | Potassium | 0.99 | 0.98 | - 0.0135 mmol/L |
| 3 | Chloride | 0.98 | 0.97 | +3.2579 mmol/L |

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The linearity test yielded the following results:

| Representative<br>Method | Linearity | |
|--------------------------|-------------------------|--|
| Sodium | 70 - 200 mmol/L (Serum) | |
| Potassium | 1 - 50 mmol/L (Serum) | |
| Chloride | 70 - 200 mmol/L (Serum) | |

The precision test results:

| | | Item | Sample 1 %CV | Sample 2 %CV |
|---|------------------------|-----------|--------------|--------------|
| 4 | Within Run<br>N=20 | Sodium | 1.0 | 0.6 |
| | | Potassium | 1.7 | 1.0 |
| | | Chloride | 0.5 | 0.8 |
| 5 | Day by Day-Run<br>N=20 | Sodium | 1.4 | 1.3 |
| | | Potassium | 1.5 | 1.3 |
| | | Chloride | 2.5 | 2.3 |

Conclusion

The data demonstrates that Prestige 24i is substantially equivalent to the Roche Cobas Mira (K851172).

3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The logo is black and white and appears to be a seal or emblem.

FEB 1 5 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Tokyo Boeki Medical System LTD. c/o Mr. James M. Clinton United States Agent Quality & Regulatory Consulting, LLC 5304 Golden Moss Trail Raleigh, NC 27613-5662

Re: k040958

Trade/Device Name: Prestige models 24i and 400 and MGC model 240 Regulation Number: 21 CFR 862.1600 Regulation Name: Potassium Test System Regulatory Class: Class II Product Code: CEM, CGZ, JGS, JIX, JJE Dated: January 28, 2005 Received: January 31, 2005

Dear Mr. Clinton:

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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#### Page 2 -

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/industry/support/index.html

Sincerely yours,

Sean M. Cooper, MS, DUM

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

510(k) Number (if known) K040958

Prestige 24i; Sirrus; MGC 240 (three identical models varying in Device Name: name only) This device with an optional Ion Selective Electrode (ISE) module Indications For Use: is a clinical chemistry analyzer intended to be used for the measurement of sodium, potassium and chloride in serum to monitor electrolyte balance.

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

AND/OR

No Over-The-Counter Use_ (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)

petinj

/(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 1070958