(215 days)
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No
The summary describes a standard automated photometric chemistry analyzer and does not mention any AI or ML capabilities. The performance studies are typical for this type of device and do not suggest the use of AI/ML.
No.
The device is an analyzer that measures analytes; it does not treat or diagnose a disease.
Yes
The device analyzes chemical analytes (Glucose, Cholesterol, Triglycerides) to provide quantitative results, which are used to aid in clinical diagnosis.
No
The device description clearly states it is an "automated system" and a "discrete photometric chemistry analyzer," which are hardware components that perform physical actions like pipetting, heating, and measuring color intensity.
Yes, based on the provided information, the Sirrus® Clinical Chemistry Analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for "clinical use" and is designed to "measure a variety of analytes to include Glucose, Cholesterol, and Triglycerides." These measurements are performed on biological samples (implied by "clinical chemistry analyzer") outside of the body (in vitro).
- Device Description: The description reinforces its purpose as an "automated system for quantitative analysis of clinical chemistries" for "clinical use."
- Functionality: The device performs steps like "pipetting, heating, and measuring color intensity," which are typical procedures in in vitro diagnostic testing.
- Analytes: The specific analytes mentioned (Glucose, Cholesterol, Triglycerides) are common targets for in vitro diagnostic tests used to assess a patient's health status.
- Performance Studies: The performance studies described (Correlation analysis and Precision studies) are standard evaluations for IVD devices to demonstrate their accuracy and reliability in measuring analytes.
- Predicate Device: The mention of a predicate device (Roche Cobas Mira®) which is also a clinical chemistry analyzer, further supports its classification as an IVD.
In summary, the Sirrus® Clinical Chemistry Analyzer fits the definition of an IVD because it is a device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for 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 to include Glucose, Cholesterol, and Triglycerides.
Product codes
JJE, CGA, CHH, CDT
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Correlation analysis between the Stanbio Laboratory Sirrus® Clinical Chemistry Analyzer and the Roche Cobas Mira Plus.
Precision studies: Within Run and Between Run.
Key Metrics
Correlation:
- Glucose: Correlation Coefficient 0.9971, Slope 0.887, Y-axis intercept 16.17 mg/dL
- Cholesterol: Correlation Coefficient 0.9894, Slope 1.126, Y-axis intercept -24.90 mg/dL
- Triglycerides: Correlation Coefficient 0.9978, Slope 0.972, Y-axis intercept -5.03 mg/dL
Within Run Precision:
- Cholesterol (Sam #1): Mean 143 mg/dL, Standard Deviation 1.50, % CV 1.05 %
- Cholesterol (Sam #2): Mean 242 mg/dL, Standard Deviation 2.68, % CV 1.11 %
- Triglycerides (Sam #1): Mean 78 mg/dL, Standard Deviation 1.35, % CV 1.73 %
- Triglycerides (Sam #2): Mean 183 mg/dL, Standard Deviation 1.79, % CV 0.98 %
Between Run Precision:
- Glucose (Sam #1): Mean 100 mg/dL, Standard Deviation 2.23, % CV 2.22%
- Glucose (Sam #2): Mean 302 mg/dL, Standard Deviation 4.86, % CV 1.61%
- Cholesterol (Sam #1): Mean 154 mg/dL, Standard Deviation 6.15, % CV 3.99%
- Cholesterol (Sam #2): Mean 263 mg/dL, Standard Deviation 4.17, % CV 1.58%
- Triglycerides (Sam #1): Mean 86 mg/dL, Standard Deviation 2.86, % CV 3.30%
- Triglycerides (Sam #2): Mean 208 mg/dL, Standard Deviation 5.56, % CV 2.67%
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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: 1 | |
| CFR: 21 CFR 862.2160 | ||
| Product Code: JJE | MAR 1 | |
| Manufacturer: | Stanbio Laboratory | |
| 1261 North Main Street | ||
| Boerne, Texas 78006 | ||
| 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
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:
| Assay | Mean
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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
4
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
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