STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER

K042169 · Stanbio Laboratory · JJE · Mar 14, 2005 · Clinical Chemistry

Device Facts

• Record ID: K042169
• Device Name: STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER
• Applicant: Stanbio Laboratory
• Product Code: JJE · Clinical Chemistry
• Decision Date: Mar 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2160
• Device Class: Class 1

Intended Use

The Sirrus® Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

Device Story

Sirrus Clinical Chemistry Analyzer; automated system for quantitative clinical chemistry analysis. Device performs automated pipetting, heating, and photometric color intensity measurement to quantify analytes. Used in clinical settings by laboratory personnel. Input: clinical samples and reagents; Output: quantitative analyte concentrations (e.g., Glucose, Cholesterol, Triglycerides). System automates manual laboratory workflows; results used by clinicians for diagnostic decision-making. Benefits include increased efficiency and consistency in clinical chemistry testing compared to manual methods.

Clinical Evidence

Bench testing only. Precision evaluated per NCCLS EP5-A; within-run CVs ranged 0.97-1.73%; between-run CVs ranged 1.58-3.99%. Method comparison against predicate (n=53) showed strong correlation: Glucose (r=0.9971), Cholesterol (r=0.9894), and Triglycerides (r=0.9978).

Technological Characteristics

Discrete photometric chemistry analyzer. Light source: tungsten halogen lamp. Detector: photo-diode. Wavelength range: 340-800 nm. Cuvettes: semi-disposable plastic (8 mm path length), automatic washing system. Pipetting: plunger driven by stepping motor with level sensing. Connectivity: Bar Code ID (39/128). Calibration: Factor, Linear, Logit-log, Spline, Exponential, Polynomial. Quality Control: Levy-Jennings, Westgard Multi-Rule.

Indications for Use

Indicated for clinical use in measuring analytes including glucose, cholesterol, and triglycerides in patient samples.

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® (K920402)

Submission Summary (Full Text)

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K042169

2005

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

(As required by 21 CFR 807.92)

| Trade Name: | Sirrus® Clinical Chemistry Analyzer | |
|-----------------------------|-------------------------------------------------------------------------------------|-------|
| Common/Classification Name: | Analyzer, Chemistry (Photometric, Discrete),<br>For Clinical Use | |
| Device Classification: | Class: 1<br>CFR: 21 CFR 862.2160<br>Product Code: JJE | MAR 1 |
| Manufacturer: | Stanbio Laboratory<br>1261 North Main Street<br>Boerne, Texas 78006<br>830 249-0772 | |

### Device Description:

The Sirrus® Clinical Chemistry Analyzer is an automated system for quantitative analysis of clinical chemistries. The analyzer is intended for clinical use in conjunction with certain materials to measure a variety of analytes.

# Intended Use:

Per 21 CFR 862.2160, the Sirrus® Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

# Substantial Equivalence:

Substantial equivalence has been demonstrated between the Sirrus® Clinical Chemistry Analyzer and the Roche Cobas Mira® (K920402).

# Comparison To Predicate Device:

#### Correlation:

A correlation analysis between the Stanbio Laboratory Sirrus® Clinical Chemistry Analyzer and the Roche Cobas Mira Plus yielded the following results:

| Assay | Correlation<br>Coefficient | Slope | Y-axis intercept |
|---------------|----------------------------|-------|------------------|
| Glucose | 0.9971 | 0.887 | 16.17 mg/dL |
| Cholesterol | 0.9894 | 1.126 | -24.90 mg/dL |
| Triglycerides | 0.9978 | 0.972 | -5.03 mg/dL |

# Precision:

#### Within Run:

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# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS cont'd

| Assay | Mean | Standard Deviation | % CV |
|------------------------|-----------|--------------------|--------|
| Cholesterol (Sam #1) | 143 mg/dL | 1.50 | 1.05 % |
| Cholesterol (Sam #2) | 242 mg/dL | 2.68 | 1.11 % |
| Triglycerides (Sam #1) | 78 mg/dL | 1.35 | 1.73 % |
| Triglycerides (Sam #2) | 183 mg/dL | 1.79 | 0.98 % |

#### Within Run cont'd

# Between Run:

| Assay | Mean | Standard Deviation | % CV |
|------------------------|-----------|--------------------|-------|
| Glucose (Sam #1) | 100 mg/dL | 2.23 | 2.22% |
| Glucose (Sam #2) | 302 mg/dL | 4.86 | 1.61% |
| Cholesterol (Sam #1) | 154 mg/dL | 6.15 | 3.99% |
| Cholesterol (Sam #2) | 263 mg/dL | 4.17 | 1.58% |
| Triglycerides (Sam #1) | 86 mg/dL | 2.86 | 3.30% |
| Triglycerides (Sam #2) | 208 mg/dL | 5.56 | 2.67% |

# Conclusion / Substantial Equivalence:

The Stanbio Laboratory Sirrus® Clinical Analyzer and the predicate device, Roche Cobas Mira®, are substantially equivalent based on design and function.

Kirk Johnson QA/Regulatory Affairs Manager Stanbio Laboratory

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 4 2005

Mr. Kirk Johnson QA/ Regulatory Affairs Manager Stanbio Laboratory 1261 North Main St. Boerne TX, 78006

k042169 Re: Trade/Device Name: Sirrus Clinical Chemistry Analyzer Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, CHH, CDT, JJE Dated: January 15, 2005 Received: February 1, 2005

Dear Mr. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reveal 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 for associated in the enactment date of the enactment date of the Medical Device Amendments, or to conimered prior to may 20, 2017 11:11 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) I ins letter will anow your to ough finding of substantial equivalence of your device to a legally promated 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 of quotions on and promise 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,

Jean 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): ____________________________________________________________________________________________________________________________________________________

Sirrus Clinical Chemistry Analyzer Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Sirrus® Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer The Silrus® Onlined Onemically Analyzet duplicate manual analytical procedures by for clinical use. The device to intonuous to tap was and measuring color intensity. automatically various otops daon as pipeting, with certain materials to measure a variety of analytes to include Glucose, Cholesterol, and Triglycerides.

| Prescription Use | <span></span> |
|-----------------------------|---------------|
| (Part 21 CFR 801 Subpart D) | <span></span> |
| AND/OR | <span></span> |
| Over-The- | (21 |

Counter Use CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cawl Benson

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