The CHEM III CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (EC02) and Ethyl Alcohol (ETOH) assays on the Dimension® clinical chemistry system.

Device Description

The Chemistry III Calibrator (CHEM III CAL) is a three level, liquid calibrator. It is packaged as a kit of six vials, two vials each of Levels 1, 2 and 3 with 2.5 mL per vial. CHEM III CAL is a multianalyte, aqueous product containing ammonium bicarbonate, sodium carbonate and ethyl alcohol.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Dimension® Chemistry III Calibrator (CHEM III CAL). It details the device's intended use and compares it to a predicate device for substantial equivalence. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the way typically expected for an AI/CADe device.

This document is for a calibrator, which is a reference material used to ensure the accuracy of assays on a clinical chemistry system. The performance characteristics discussed here relate to the stability of the calibrator itself, not to the diagnostic performance of an AI algorithm based on patient data.

Therefore, many of the requested fields (like sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size, and how training ground truth was established) are not applicable to this type of device and FDA submission.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

The document describes performance characteristics related to the stability of the calibrator, which can be interpreted as demonstrating its functional acceptance.

Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Opened Vial Stability (on Dimension® system)	Stable for a specified duration	Stable for 7 days
Opened Vial Stability (recapped & stored at 2-8°C)	Stable for a specified duration	Stable for 30 days
Shelf Life	Stable for a specified duration	12 months

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Applicable. This device is a calibrator, and its performance is evaluated in terms of its stability and ability to maintain assigned values over time and under specific storage conditions. It does not analyze patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not Applicable. Ground truth for this device relates to the accurately assigned values of the analytes within the calibrator (Ammonia, Carbon Dioxide, Ethyl Alcohol), which are established through certified reference materials and analytical chemistry methods, not expert consensus on patient data. The traceability to ASC Grade Ammonium Sulfate, NIST SRM 351, and USP Grade Ethyl Alcohol for the analytes (AMM, ECO2, ETOH) is mentioned, indicating the origin of the referent values.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. Adjudication methods are relevant for subjective interpretations of data, typically in AI/CADe diagnostic device studies. This is a chemical calibrator.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This is not an AI/CADe device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is not an AI/CADe device or an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The closest equivalent to "ground truth" for this device is the traceability of the analyte values to recognized standards:
- AMM - ASC Grade Ammonium Sulfate
- EC02 - NIST SRM 351
- ETOH - USP Grade Ethyl Alcohol
  These standards ensure the accuracy of the assigned values in the calibrator.

8. The sample size for the training set:

Not Applicable. This device does not use a training set in the context of machine learning.

9. How the ground truth for the training set was established:

Not Applicable. This device does not use a training set.

Study/Evidence that Proves the Device Meets Acceptance Criteria:

The document states: "The shelf life of the Dimension® CHEM III CAL is 12 months." and "For opened products, once the cap is removed, assigned values are stable for 7 days . stored on the Dimension® clinical chemistry system." and "Once cap is removed, assigned values are stable for 30 days when recapped immediately after use and stored at 2-8°C."

The "study" or evidence for these claims would typically involve a stability study, designed according to recognized guidelines such as CLSI EP25-A, "Evaluation of Stability of In Vitro Diagnostic Reagents." This guideline, which is referenced in the document, outlines protocols for determining the shelf life and in-use stability of diagnostic reagents and calibrators by measuring the analyte concentrations at various time points under different storage conditions and comparing them to initial values or reference standards. The acceptance criteria would be that the measured values remain within a pre-defined acceptable range (e.g., ±X% of the assigned value) throughout the claimed stability period.

While the document references the CLSI guideline, it does not provide the specific raw data, methodology details of the stability study (e.g., number of lots tested, analytical methods used for measurements), or the exact acceptance limits used to determine the stated stability claims (7 days, 30 days, 12 months). It only reports the results of such studies.

Summary

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(123321

510k Summary

FEB 1 5 2013

Dimension® Chemistry III Calibrator (CHEM III CAL)

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

1. 510(k) Number

1. Applicant: Rose T. Marinelli Siemens Healthcare Diagnostics, Inc. P.O. Box 6101, Newark, DE 19714-6101. Office Number: 302-631-8805; Fax Number: 302-631-6299

Date: October 25, 2012

4. Proprietary and Established Names:

Dimension® Chemistry III Calibrator (CHEM III CAL)

5. Requlatory Information:

Chemistry III Calibrator (CHEM III CAL)

Requlation section: 21 CFR 862.1150 Calibrator, Multi-Analyte Classification: Class II Product Code: JIX. Panel: Clinical Chemistry

6. Predicate Devices:

The predicate device used to demonstrate substantial equivalence to the Dimension® Chemistry III Calibrator (CHEM III CAL) is the Dimension Vista® Chemistry 3 Calibrator (CHEM 3 CAL) previously cleared under K062334.

7. Device Description:

8. Intended Use:

The CHEM III CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (ECO2) and Ethyl Alcohol (ETOH) assays on the Dimension® clinical chemistry svstem.

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9. Indication(s) for Use:

The CHEM III CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (ECO2) and Ethyl Alcohol (ETOH) assays on the Dimension® clinical chemistry system.

10. Substantial Equivalence Information:

Similarities for Dimension® CHEM III CAL

Feature	New Device: Dimension®Chemistry III Calibrator (CHEM IIICAL) (DC130)	Predicate: Dimension Vista®Chem 3 Calibrator (CHEM 3CAL) (KC130) K062334
Preparation	Liquid:Provided ready to use.	Liquid:Provided ready to use.
Storage	2 – 8 °C	2 - 8 °C
Matrix	Aqueous product containing ethylalcohol, ammonium bicarbonateand sodium carbonate.	Aqueous product containingethyl alcohol, ammoniumbicarbonate and sodiumcarbonate.
Traceability	AMM - ASC Grade AmmoniumSulfateEC02 -- NIST SRM 351ETOH - USP Grade Ethyl Alcohol	AMM - ASC Grade AmmoniumSulfateEC02 - NIST SRM 351ETOH - USP Grade EthylAlcohol

Differences for Dimension® CHEM III CAL

Feature	New Device: Dimension®Chemistry III Calibrator (CHEM3 CAL) (DC130)	Predicate: Dimension Vista®Chem 3 Calibrator (CHEM 3 CAL)(KC130)
Intended Use	The CHEM III CAL is an in vitrodiagnostic product for thecalibration of Ammonia (AMM),Carbon Dioxide (EC02) andEthyl Alcohol (ETOH) assays onthe Dimension® clinicalchemistry system.	The CHEM 3 CAL is an in vitrodiagnostic product for the calibration.of Ammonia (AMON), CarbonDioxide (C02) and Ethyl Alcohol(ETOH) methods on the DimensionVista® System.
Units	µg/dL and µmol/L	µmol/L
CalibratorLevels	3 levels	2 levels
CalibratorLevels forAMM only	Calibrator Level 3 – 1405 µg/dL[825 µmol/L]	Calibrator Level 3 – 1050 µmol/L

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11. Standard/Guidance Document Reference:

· CLSI, EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline; 2009.

12. Performance Characteristics

Calibrator

For opened products, once the cap is removed, assigned values are stable for 7 days . stored on the Dimension® clinical chemistry system.
. Once cap is removed, assigned values are stable for 30 days when recapped immediately after use and stored at 2-8°C.

The shelf life of the Dimension® CHEM III CAL is 12 months.

Conclusion: The Dimension® Chemistry III Calibrator (CHEM III CAL) is substantially equivalent in principle and performance to the Dimension Vista® Chemistry 3 Calibrator.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 15.2013

Siemens Healthcare Diagnostics, Inc. c/o Rose T. Marinelli 500 GBC Drive P.O. Box 6101/MS 514 Newark, DE 19714-6101

Re: K123321

Trade/Device Name: Dimension Chemistry III Calibrator (CHEM III CAL) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIX Dated: February 01, 2013 Received: February 07, 2013

Dear Ms. Marinelli:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2—Ms. Marinelli

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carol C. Benson for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123321

Device Name: Dimension® Chemistry III Calibrator (CHEM III CAL)

Indications for Use:

The CHEM III CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (C02) and Ethyl Alcohol (ETOH) methods on the Dimension® clinical chemistry system.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Denise Johnson-lyles -S 2013.02.15 10:17:42 -05'00'

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

K123321 510(k)

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
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.)(b)
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.