A lithium test system is a device intended to measure lithium levels in serum or plasma. Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder). For use on Architect and Aeroset analyzers.

Device Description

The Multigent Lithium test is a spectrophotometric method, which can be readily adapted to automated clinical chemistry analyzers. Lithium present in the sample reacts with a substituted porphyrin compound at an alkaline pH, resulting in a change of absorbance, which is directly proportional to the concentration of lithium in the sample.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Multigent Lithium device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric (Predicate Device: Infinity Lithium Liquid Stable Reagent assay on Hitachi 911 Analyzer)	Achieved Performance (Multigent Lithium)
Correlation	Correlation coefficient: Not explicitly stated for acceptance, but implied to be high for equivalence.	AEROSET System: 0.999
		ARCHITECT c8000 System: 0.999
Slope	Slope: Not explicitly stated for acceptance, but implied to be near 1 for equivalence.	AEROSET System: 1.013
		ARCHITECT c8000 System: 0.991
Y-intercept	Y-intercept: Not explicitly stated for acceptance, but implied to be near 0 for equivalence.	AEROSET System: -0.025 mmol/L
		ARCHITECT c8000 System: -0.004 mmol/L
Precision (%CV)	%CV: Not explicitly stated for acceptance, but implied to be functionally acceptable for clinical use.	AEROSET System: Level 1: 4.76%, Level 2: 3.67%, Level 3: 2.96%
		ARCHITECT c8000 System: Level 1: 2.53%, Level 2: 1.88%, Level 3: 2.02%
Linearity (Upper Limit)	Linearity: Not explicitly stated for acceptance, but implied to cover the clinical range.	Up to 3.51 mmol/L
Limit of Quantitation (Sensitivity)	Sensitivity: Not explicitly stated for acceptance, but implied to be clinically relevant.	0.10 mmol/L

Note: The acceptance criteria are implicitly defined by the claim of "similar Performance Characteristics" and "substantially equivalent" to the predicate device. Specific numerical thresholds for acceptance are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the comparative performance studies. It mentions "comparative performance studies were conducted," but details on the number of samples are absent.

Data Provenance: Not specified. It's unclear if the data was collected retrospectively or prospectively, or the country of origin.

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

Not applicable. This device is a diagnostic reagent for measuring lithium levels, which are typically determined by laboratory analysis and not by expert human interpretation of images or other subjective data. The "ground truth" in this context would be the actual concentration of lithium in the samples, as determined by the predicate device (Infinity Lithium Liquid Stable Reagent assay on the Hitachi 911 Analyzer) or a reference method.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this study involves objective chemical measurements, not subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for devices that involve human interpretation of diagnostic images (e.g., radiology AI), not for objective chemical assays like this lithium test.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this study is inherently a standalone performance evaluation of the Multigent Lithium assay. It compares the analytical performance of the new assay directly against a predicate device, without involving human interpretation as an outcome. The device itself performs the measurement.

7. The Type of Ground Truth Used

The ground truth for the device's performance comparison was the results obtained from the predicate device, the Infinity Lithium Liquid Stable Reagent assay on the Hitachi 911 Analyzer.

8. The Sample Size for the Training Set

Not applicable. For a diagnostic reagent intended for chemical measurement, there isn't typically a "training set" in the machine learning sense. The assay is developed based on chemical principles and extensively tested for analytical performance.

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

Not applicable, as there isn't a traditional "training set" with ground truth in this context. The development process would involve optimizing the reagent's formulation and reaction conditions to accurately measure lithium, with performance validated against reference methods and established predicate devices.

Summary

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510(k) Summary

AUG - 2 2007

Submitter's Name/Address SENTINEL CH. Via Robert Koch, 2 20152 Milan - Italy

Contact Person Fabio Rota Technical Director +39 02 3455148 Fax: +39 02 34551464

Date of Preparation of this Summary:	March 30, 2007
Device Trade or Proprietary Name:	Multigent Lithium
Device Common/Usual Name or Classification Name:	Lithium
Classification Number/Class:	NDW/Class II

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: 407098

Test Description:

Substantial Equivalence:

The Multigent Lithium assay is substantially equivalent to the Infinity Lithium Liquid Stable Reagent assay (K003583) on the Hitachi 911 Analyzer. These assays yield similar Performance Characteristics.

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Similarities:

. Both assays are in vitro clinical chemistry methods.
. Both assays can be used for the quantitative determination of lithium in serum or plasma.
. Both assays yield similar clinical results.
. Both assays claim similar assay ranges.

Differences:

None.

Intended Use:

The Multigent Lithium assay is used for the quantitation of lithium in serum or plasma.

Performance Characteristics:

Comparative performance studies were conducted using the AEROSET and ARCHITECT c8000 Systems. The Multigent Lithium assay method comparison yielded acceptable correlation with Infinity Lithium Liquid Stable Reagent assay on the Hitachi 911 Analyzer. The AEROSET System showed a correlation coefficient of 0.999, slope of 1.013, and Y-intercept of -0.025 mmol/L when compared to Infinity Lithium on the Hitachi 911. The ARCHITECT c8000 System showed a correlation coefficient of 0.999, slope of 0.991, and Y-intercept of -- 0.004 mmol/L when compared to Infinity Lithium on the Hitachi 911. Precision studies were conducted using the Multigent Lithium assay. On the AEROSET System the total %CV for Level 1 is 4.76%, Level 2 is 3.67%, and Level 3 is 2.96%. On the ARCHITECT c8000 System the total %CV for Level 1 is 2.53%, Level 2 is 1.88%, and Level 3 is 2.02%. The Multigent Lithium assay is linear up to 3.51 mmol/L. The limit of quantititation (sensitivity) of the Multigent Lithium assay is 0.10 mmol/L. These data demonstrate that the performance of the Sentinel Lithium assay is substantially equivalent to the performance of the Infinity Lithium Liquid Stable Reagent assay on the Hitachi 911 Analyzer.

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Conclusion:

The Multigent Lithium is substantially equivalent to the Infinity Lithium Liquid Stable Reagent assay on the Hitachi 911 Analyzer as demonstrated by results obtained in the studies.

Reagent Name 510(k)
July 13, 2007

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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 tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Sentinel CH. SpA c/o Mr. Fabio Rota, Technical Director Via Robert Koch, 2 20152 Milano Italy

AUG - 2 2007

Re: K070987 Trade/Device Name: Multigent Lithium Regulation Number: 21 CFR§862.3560 Regulation Name: Lithium Test System Regulatory Class: Class II Product Code: NDW Dated: June 21, 2007 Received: June 25, 2007

Dear Mr. Rota:

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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This letter will allow you to begin marketing your device as described in your Section 510(k) I this letter with anow your to begal finding of substantial equivalence of your device to a legally promative netireation - - e 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, n you desire specific mostion and advertising of your device, please contact the Office of In of quebtions on the prome Evaluation and Safety at (240) 276-0490. 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 Tou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jéan M. Cooper, M.S., 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): _070987

Device Name:

Indications For Use:

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)
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Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k)	K070987

Regulation Number and Section

§ 862.3560 Lithium test system.

(a)
Identification. A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).(b)
Classification. Class II.