(118 days)
No
The description details a spectrophotometric chemical reaction and standard performance metrics for a laboratory assay, with no mention of AI or ML.
No
The device measures lithium levels to aid in management, but it does not directly treat or restore health.
Yes
Explanation: The device is intended to measure lithium levels to "aid in the management of individuals taking lithium for the treatment of mental disturbances," which directly contributes to understanding a patient's medical condition and guiding treatment decisions.
No
The device description clearly states it is a "spectrophotometric method" and a "reagent assay," indicating it involves chemical reagents and a physical measurement process, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to measure lithium levels in serum or plasma." This is a diagnostic measurement performed on biological samples in vitro (outside the body).
- Purpose of Measurement: The measurements are used "to aid in the management of individuals taking lithium for the treatment of mental disturbances." This indicates a diagnostic purpose related to patient care and treatment monitoring.
- Device Description: The description details a "spectrophotometric method" that reacts with a sample to produce a measurable change, which is characteristic of an in vitro assay.
- Sample Type: The device measures lithium in "serum or plasma," which are biological samples.
These characteristics align directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
The Multigent Lithium assay is used for the quantitation of lithium in serum or plasma. 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.
Product codes
NDW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
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.
Key Metrics
AEROSET System: correlation coefficient of 0.999, slope of 1.013, Y-intercept of -0.025 mmol/L. Total %CV: Level 1 is 4.76%, Level 2 is 3.67%, and Level 3 is 2.96%.
ARCHITECT c8000 System: correlation coefficient of 0.999, slope of 0.991, Y-intercept of -- 0.004 mmol/L. Total %CV: Level 1 is 2.53%, Level 2 is 1.88%, and Level 3 is 2.02%.
Linearity: up to 3.51 mmol/L.
Limit of quantitation (sensitivity): 0.10 mmol/L.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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:
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.
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.
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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:
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.
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)
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| 510(k) | K070987 |