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 to include Glucose, Cholesterol, and Triglycerides.

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.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study proving the device meets those criteria:

Device: Sirrus® Clinical Chemistry Analyzer

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are presented through correlation and precision studies, comparing the Sirrus® Clinical Chemistry Analyzer to the predicate device, Roche Cobas Mira®. The summary outlines the performance criteria for correlation via correlation coefficient, slope, and y-intercept, and for precision via Standard Deviation and %CV.

Study Type	Analyte	Acceptance Criteria (Predicate Performance)	Reported Device Performance (Sirrus)
Correlation	Glucose	Not explicitly stated as "acceptance criteria" but implied via comparison to predicate. The predicate (Roche Cobas Mira®) is assumed to have acceptable correlation values, and the Sirrus aims to demonstrate similar performance.	Correlation Coefficient: 0.9971, Slope: 0.887, Y-axis intercept: 16.17 mg/dL
	Cholesterol	(Same as above)	Correlation Coefficient: 0.9894, Slope: 1.126, Y-axis intercept: -24.90 mg/dL
	Triglycerides	(Same as above)	Correlation Coefficient: 0.9978, Slope: 0.972, Y-axis intercept: -5.03 mg/dL
Precision
Within Run	Cholesterol (Sam #1)	Not explicitly stated, but typically a low %CV is desired for good precision.	Mean: 143 mg/dL, SD: 1.50, % CV: 1.05 %
	Cholesterol (Sam #2)	Not explicitly stated	Mean: 242 mg/dL, SD: 2.68, % CV: 1.11 %
	Triglycerides (Sam #1)	Not explicitly stated	Mean: 78 mg/dL, SD: 1.35, % CV: 1.73 %
	Triglycerides (Sam #2)	Not explicitly stated	Mean: 183 mg/dL, SD: 1.79, % CV: 0.98 %
Between Run	Glucose (Sam #1)	Not explicitly stated	Mean: 100 mg/dL, SD: 2.23, % CV: 2.22%
	Glucose (Sam #2)	Not explicitly stated	Mean: 302 mg/dL, SD: 4.86, % CV: 1.61%
	Cholesterol (Sam #1)	Not explicitly stated	Mean: 154 mg/dL, SD: 6.15, % CV: 3.99%
	Cholesterol (Sam #2)	Not explicitly stated	Mean: 263 mg/dL, SD: 4.17, % CV: 1.58%
	Triglycerides (Sam #1)	Not explicitly stated	Mean: 86 mg/dL, SD: 2.86, % CV: 3.30%
	Triglycerides (Sam #2)	Not explicitly stated	Mean: 208 mg/dL, SD: 5.56, % CV: 2.67%

Note on Acceptance Criteria: For this type of device (clinical chemistry analyzer), the "acceptance criteria" are implicitly met by demonstrating performance (correlation and precision) that is comparable to a legally marketed predicate device (Roche Cobas Mira®). The summary doesn't explicitly state numerical acceptance thresholds for these metrics beyond the reported predicate performance, but rather presents the Sirrus's performance against the predicate's expected performance through various trials. The FDA's substantial equivalence determination implies that these results were found acceptable.

2. Sample Size for the Test Set and Data Provenance

Sample Size: The document does not explicitly state the sample size (number of patient samples) used for the correlation and precision studies. It refers to "Sam #1" and "Sam #2" for precision, implying multiple samples or control levels were tested, but not the total number of individual runs or replicates.
Data Provenance: The document does not specify the country of origin of the data. The studies appear to be laboratory-based evaluations for performance characteristics. There is no information to indicate if the data is retrospective or prospective patient data, it's more likely referring to control samples or spiked samples in a laboratory setting typical for instrument validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of device (a clinical chemistry analyzer) does not typically involve human experts establishing "ground truth" in the way a diagnostic imaging AI might. The "ground truth" for the test set is established by the reference values obtained from the predicate device (Roche Cobas Mira®) for correlation studies, and through the inherent accuracy and precision of the analytical methods themselves for precision studies, often using certified reference materials or control solutions with known values. Therefore, this section is not applicable in the traditional sense.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, the "ground truth" for a clinical chemistry analyzer's performance (correlation and precision) is determined by comparison to a predicate device and established analytical methods, not by expert adjudication of individual cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is not applicable for a standalone clinical chemistry analyzer like the Sirrus®. This type of study is relevant for diagnostic imaging AI devices where human readers interpret results with and without AI assistance.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

Yes, the performance data presented (correlation and precision) represents the standalone performance of the Sirrus® Clinical Chemistry Analyzer. It's an automated system intended to duplicate manual analytical procedures, meaning its performance is evaluated based on its own output against established reference methods or predicate devices, without human intervention in the result generation process.

7. The Type of Ground Truth Used

Correlation Study: The ground truth for the correlation study is implicitly the results obtained from the predicate device (Roche Cobas Mira®). The Sirrus® device's measurements are compared against these predicate values to establish correlation.
Precision Study: The ground truth for the precision study involves known concentrations of analytes in control samples ("Sam #1," "Sam #2"). The consistency of the Sirrus® device's measurements around these known means or its own calculated mean demonstrates its precision.

8. The Sample Size for the Training Set

Not applicable. The Sirrus® Clinical Chemistry Analyzer is a hardware device that performs chemical assays based on established photometric principles, not a machine learning or AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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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),For Clinical Use
Device Classification:	Class: 1CFR: 21 CFR 862.2160Product Code: JJE	MAR 1
Manufacturer:	Stanbio Laboratory1261 North Main StreetBoerne, Texas 78006830 249-0772

Device Description:

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	CorrelationCoefficient	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:

Assay	MeanBut Career on considered an experiences of a proposition of a commission of a commission of a commission of a commission of a commission of a commission of a commission of a	Standard Deviation

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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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Image /page/2/Picture/1 description: The image shows a logo with a stylized bird-like figure, possibly an eagle or similar bird of prey. The bird is depicted with three distinct, curved lines forming its head, body, and tail. The logo also includes text, with 'SERVICES USA' visible at the top and 'DEPA' at the bottom, both oriented vertically along the edges of the image. The logo is black and white.

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 (240)276-0484. 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 (800) 638-2041 or (301) 443-6597 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
(Part 21 CFR 801 Subpart D)
AND/OR
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

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

11 11 11

Regulation Number and Section

§ 862.2160 Discrete photometric chemistry analyzer for clinical use.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.