The LITH method is an in vitro diagnostic test for the quantitative measurement of lithium in human serum and plasma on the Dimension Vista® System. 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).

The Drug 4 CAL is an in vitro diagnostic product for the calibration of the LOCI Digoxin (DIGXN) and Lithium (LITH) methods on the Dimension Vista® System.

Device Description

The LITH method employs a lithium-specific chromoionophore that forms a complex with the Li+ ion in an alkaline solution. The concentration of lithium in the sample is proportional to the increase in absorbance, which is due to the formation of the dye-lithium complex. The reaction is measured using a Bichromatic (510 and 700 mm) endpoint technique.

The Drug 4 Calibrator is a five (5) level, liquid calibrator. It is packaged as a kit of ten vials per level (A, B, C, D and E), 2.5 mL per vial. The product matrix is liquid human serum and contains digoxin and lithium. This product is sold separately from the Flex® reagent cartridge.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Dimension Vista® Lithium (LITH) Flex® Reagent Cartridge and Dimension Vista® Drug 4 Calibrator, based on the provided text:

Overview:

The submission focuses on demonstrating "substantial equivalence" to predicate devices. This means the new devices (Dimension Vista® Lithium Flex® Reagent Cartridge and Dimension Vista® Drug 4 Calibrator) perform similarly enough to existing, legally marketed devices (Dimension® Lithium Flex® Reagent Cartridge K011033 and Dimension® Drug Calibrator K011035) that they don't raise new questions of safety or effectiveness. The primary study type is comparative testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly met if the new device performs comparably to the predicate device, as demonstrated through comparative testing. The document states "Comparative testing described in the submission report demonstrates substantial equivalent performance."

Here’s a table summarizing the features compared, which serve as the basis for demonstrating substantial equivalence:

Dimension Vista® Lithium (LITH) Flex® Reagent Cartridge vs. Predicate (K011033)

Feature	Acceptance Criteria (Predicate: Dimension® Lithium (LI) K011033)	Reported Device Performance (Dimension Vista® Lithium (LITH) K4150)
Intended Use	Quantitative measurement of lithium in human serum and plasma on Dimension® systems for drug dosage assurance in mental disturbances.	Quantitative measurement of lithium in human serum and plasma on the Dimension Vista® System for drug dosage assurance in mental disturbances. (Identical)
Sample Type	Serum and Sodium Heparin Plasma	Serum and Sodium Heparin Plasma
Measuring Range	0.20 - 5.00 mmol/L	0.20 - 3.00 mmol/L
Sample Size	10 µL	2 µL
Measurement	Bichromatic endpoint (540 and 700 nm)	Bichromatic endpoint (510 and 700 nm)

Dimension Vista® Drug 4 Calibrator vs. Predicate (K011035)

Feature	Acceptance Criteria (Predicate: Dimension® Drug Calibrator K011035)	Reported Device Performance (Dimension Vista® DRUG 4 CAL KC460A)
Intended Use	Calibration of DIG, LI, PHNO, PTN, and THEO methods on Dimension Vista® System.	Calibration of LOCI Digoxin (DIGXN) and Lithium (LITH) methods on the Dimension Vista® System.
Matrix	Human serum based	Human serum based
Preparation	Liquid: Provided ready to use.	Liquid: Provided ready to use.
Target Concentrations	Level 1: ≤ 0.20 mmol/LLevel 2: 0.80 - 1.00 mmol/LLevel 3: 1.71 - 1.89 mmol/LLevel 4: 3.42 - 3.78 mmol/LLevel 5: 5.22 - 5.78 mmol/L	Level 1: ≤ 0.20 mmol/LLevel 2: 0.77 - 1.15 mmol/LLevel 3: 1.67 - 2.00 mmol/LLevel 4: 3.35 - 3.85 mmol/LLevel 5: 5.12 - 5.89 mmol/L
Storage	Store at 2 to 8 °C.	Store at 2 - 8 °C.

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

The document states "Comparative testing described in the submission report demonstrates substantial equivalent performance." However, the exact sample sizes for the test set (e.g., number of patient samples, controls) are not specified within the provided text.

The data provenance is also not explicitly stated (e.g., country of origin, retrospective/prospective). As an in vitro diagnostic device, it's highly likely that samples would be human serum and plasma, but the source specifics are missing.

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

This information is not applicable and not provided in the context of this device. This is a quantitative chemical assay, not an imaging device or diagnostic interpretation requiring expert human adjudication. The "ground truth" for calibrators and reagent cartridges like these is typically established through analytical methods, reference materials, and specified concentrations, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable and not provided. As explained in point 3, this is a quantitative chemical assay, not a diagnostic interpretation that would involve adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating a diagnostic aid that assists human readers (e.g., AI in radiology). The devices in question are reagents and calibrators for a laboratory instrument, not tools for human interpretation.

6. If a Standalone Performance Study was Done

Yes, in essence, standalone performance was assessed as part of the "comparative testing" mentioned. For an in vitro diagnostic device, demonstrating performance against a predicate device (rather than a human reader) is the standard. The device's performance properties (e.g., precision, measuring range, analytical specificity) would be evaluated when operating on its own as designed, and then these results would be compared to the predicate. The document states "Comparative testing described in the submission report demonstrates substantial equivalent performance," indicating the new device's performance was measured.

7. The Type of Ground Truth Used

The ground truth for these types of devices is based on analytical validation and reference methods.

For the Lithium Flex® Reagent Cartridge: The "ground truth" for lithium concentration in samples would be established by reference methods or validated comparative methods, against which the device's quantitative measurements are compared to assess accuracy, precision, and linearity.

For the Drug 4 Calibrator: The "ground truth" for the calibrator's target concentrations (Levels 1-5) is established by precise formulation and measurement against recognized standards. The matrix itself (human serum) is a specified component.

8. The Sample Size for the Training Set

Not applicable and not provided. These are chemical reagents and calibrators for an IVD assay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The development and optimization of such reagents involve experimental design, formulation studies, and analytical verification, rather than machine learning training.

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

Not applicable and not provided. As explained in point 8, there is no "training set" in the context of these devices.

Summary

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510(k) Summary of Safety and Effectiveness for the

Dimension Vista® Lithium (LITH) Flex® Reagent Cartridge

Dimension Vista® Drug 4 Calibrator

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.

A. 510(k) Number: k112142

B. Date of Preparation: July 25, 2011

C. Proprietary and Established Names:

Dimension Vista® Lithium (LITH) Flex® Reagent Cartridge (K4150)

Dimension Vista® Drug 4 Calibrator, DRUG 4 CAL (KC460A)

D. Applicant:

Siemens Healthcare Diagnostics Inc.

P.O. Box 6101, Newark, DE 19714-6101

Rose Marinelli, Regulatory Technical Specialist

Office Number: (302) 631-8805; Fax Number: (302) 631-6299

E. Regulatory Information:

Lithium (LITH) Flex® Reagent Cartridge:

1. Regulation section: 21 CFR § 862.3560 Lithium test system
1. Classification: Class II
1. Product Code: NDW
1. Panel: Clinical Toxicology Test Systems

Drug 4 Calibrator:

1. Regulation section: 21 CFR § 862.1150 Calibrator
1. Classification: Class II
1. Product Code: JIX Calibrator, Multi-Analyte Mixture
1. Panel: Clinical Chemistry Test Systems

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F. Predicate Device:

The predicate device used to demonstrate substantial equivalence to the Dimension Vista® Lithium (LITH) Flex® Reagent Cartridge is the Dimension® Lithium (LI) Flex® Reagent Cartridge previously cleared under K011033.

The predicate device used to demonstrate substantial equivalence to the Dimension Vista® Drug 4 Calibrator is the current commercial Dimension® Drug Calibrator previously cleared under K011035.

G. Device Description: The LITH method employs a lithium-specific chromoionophore that forms a complex with the Li+ ion in an alkaline solution.

Li+ + Lithium Dye > Dye - Li Complex (absorbs at 510 nm)

The concentration of lithium in the sample is proportional to the increase in absorbance, which is due to the formation of the dye-lithium complex. The reaction is measured using a Bichromatic (510 and 700 mm) endpoint technique.

H. Intended Use: The LITH method is an in virro diagnostic test for the quantitative measurement of lithium in human serum and plasma on the Dimension Vista® System. 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).

The Drug 4 CAL is an in vitro diagnostic product for the calibration of the LOCI Digoxin (DIGXN) and Lithium (LITH) methods on the Dimension Vista® System.

I. Substantial Equivalence Information:

The Dimension Vista® Lithium Flex® reagent cartridge, (LITH) K4150 and Dimension Vista® Drug 4 Calibrator (DRUG 4 CAL), KC460A were compared to the respective predicate devices, Dimension Lithium, (LI) DF132, cleared under K011033 and Dimension® Drug Calibrator (DRUG CAL) DC22B, cleared under K011035. A comparison of the similarities and differences between the devices is provided in the following tables:

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Feature	Dimension Vista® Lithium (LITH)K4150	Predicate: Dimension® Lithium (LI)K011033 - DF132
Intended Use	The LITH method is an in vitro diagnostictest for the quantitative measurement oflithium in human serum and plasma on theDimension Vista® System. Measurementsof lithium are used to assure that theproper drug dosage is administered in thetreatment of patients with mentaldisturbances, such as manic-depressiveillness (bipolar disorder).	The LI method used on the Dimension®clinical chemistry systems is an in vitrodiagnostic test intended to quantitativelymeasure lithium in human serum andplasma (sodium heparin). Measurements oflithium are used to assure that the properdrug dosage is administered in thetreatment of patients with mentaldisturbances, such as manic-depressiveillness (bipolar disorder).
Sample Type	Serum and Sodium Heparin Plasma	Serum and Sodium Heparin Plasma
MeasuringRange	0.20 - 3.00 mmol/L	0.20 - 5.00 mmol/L
Sample Size	2 µL	10 µL
Measurement	Bichromatic endpoint (510 and 700 nm)	Bichromatic endpoint (540 and 700 nm)

Feature	Dimension Vista® DRUG 4 CAL(KC460A)	Predicate: Dimension® DRUG CAL(DC22B) K011035
Intended Use	The Drug 4 CAL is an in vitrodiagnostic product for the calibration ofthe LOCI Digoxin (DIGXN) andLithium (LITH) methods on theDimension Vista® System.	The Drug 1 CAL is an in vitrodiagnostic product for the calibrationof the Digoxin (DIG), Lithium (LI),Phenobarbital (PHNO), Phenytoin(PTN) and Theophylline (THEO)methods on the Dimension Vista®System.
Matrix	Human serum based	Human serum based
Preparation	Liquid:Provided ready to use.	Liquid:Provided ready to use.
TargetConcentrations	Level 1 (CAL A): ≤ 0.20 mmol/LLevel 2 (CAL B): 0.77 - 1.15 mmol/LLevel 3 (CAL C): 1.67 - 2.00 mmol/LLevel 4 (CAL D): 3.35 - 3.85 mmol/LLevel 5 (CAL E): 5.12 - 5.89 mmol/L	Level 1: ≤ 0.20 mmol/LLevel 2: 0.80 - 1.00 mmol/LLevel 3: 1.71 - 1.89 mmol/LLevel 4: 3.42 - 3.78 mmol/LLevel 5: 5.22 - 5.78 mmol/L
Storage	Store at 2 - 8 °C.	Store at 2 to 8 °C.

J. Conclusion:

The Lithium (LITH) Flex® reagent cartridge is substantially equivalent to the Dimension® Lithium (LI) (K011033). The Dimension Vista® Drug 4 Calibrator (DRUG 4 CAL) is substantially equivalent to the Dimension® Drug Calibrator (DRUG CAL) (K011035). Comparative testing described in the submission report demonstrates substantial equivalent performance.

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510(k) Summary of Safety and Effectiveness for the

Dimension Vista® Lithium (LITH) Flex® Reagent Cartridge

Dimension Vista® Drug 4 Calibrator

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.

A. 510(k) Number:

B. Date of Preparation: July 25, 2011

C. Proprietary and Established Names:

Dimension Vista® Lithium (LITH) Flex® Reagent Cartridge (K4150)

Dimension Vista® Drug 4 Calibrator, DRUG 4 CAL (KC460A)

D. Applicant:

Siemens Healthcare Diagnostics Inc.

P.O. Box 6101, Newark, DE 19714-6101

Rose Marinelli, Regulatory Technical Specialist

Office Number: (302) 631-8805; Fax Number: (302) 631-6299

E. Regulatory Information:

Lithium (LITH) Flex® Reagent Cartridge:

1. Regulation section: 21 CFR § 862.3560 Lithium test system
1. Classification: Class II
1. Product Code: NDW
1. Panel: Clinical Toxicology Test Systems

Drug 4 Calibrator:

1. Regulation section: 21 CFR § 862.1150 Calibrator
1. Classification: Class II
1. Product Code: JIX Calibrator, Multi-Analyte Mixture
1. Panel: Clinical Chemistry Test Systems

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F. Predicate Device:

The predicate device used to demonstrate substantial equivalence to the Dimension Vista® Drug 4 Calibrator is the current commercial Dimension® Drug Calibrator previously cleared under K011035.

G. Device Description: The LITH method employs a lithium-specific chromoionophore that forms a complex with the Li+ ion in an alkaline solution.

Li+ + Lithium Dye > Dye - Li Complex (absorbs at 510 nm)

The Drug 4 Calibrator is a five (5) level, liquid calibrator. It is packaged as a kit of ten vials per level (A, B, C, D and E), 2.5 mL per vial. The product matrix is liguid human serum and contains digoxin and lithium. This product is sold separately from the Flex® reagent cartridge.

H. Intended Use: The LITH method is an in vitro diagnostic test for the quantitative measurement of lithium in human serum and plasma on the Dimension Vista® System. 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).

The Drug 4 CAL is an in vitro diagnostic product for the calibration of the LOCI Digoxin (DIGXN) and Lithium (LITH) methods on the Dimension Vista® System.

I. Substantial Equivalence Information:

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Feature	Dimension Vista® Lithium (LITH)K4150	Predicate: Dimension® Lithium (LI)K011033 - DF132
Intended Use	The LITH method is an in vitro diagnostictest for the quantitative measurement oflithium in human serum and plasma on theDimension Vista® System. Measurementsof lithium are used to assure that theproper drug dosage is administered in thetreatment of patients with mentaldisturbances, such as manic-depressiveillness (bipolar disorder).	The LI method used on the Dimension®clinical chemistry systems is an in vitrodiagnostic test intended to quantitativelymeasure lithium in human serum andplasma (sodium heparin). Measurements oflithium are used to assure that the properdrug dosage is administered in thetreatment of patients with mentaldisturbances, such as manic-depressiveillness (bipolar disorder).
Sample Type	Serum and Sodium Heparin Plasma	Serum and Sodium Heparin Plasma
MeasuringRange	0.20 - 3.00 mmol/L	0.20 - 5.00 mmol/L
Sample Size	2 µL	10 µL
Measurement	Bichromatic endpoint (510 and 700 nm)	Bichromatic endpoint (540 and 700 nm)

Feature	Dimension Vista® DRUG 4 CAL(KC460A)	Predicate: Dimension® DRUG CAL(DC22B) K011035
Intended Use	The Drug 4 CAL is an in vitrodiagnostic product for the calibration ofthe LOCI Digoxin (DIGXN) andLithium (LITH) methods on theDimension Vista® System.	The Drug 1 CAL is an in vitrodiagnostic product for the calibrationof the Digoxin (DIG), Lithium (LI),Phenobarbital (PHNO), Phenytoin(PTN) and Theophylline (THEO)methods on the Dimension Vista®System.
Matrix	Human serum based	Human serum based
Preparation	Liquid:Provided ready to use.	Liquid:Provided ready to use.
TargetConcentrations	Level 1 (CAL A): ≤ 0.20 mmol/LLevel 2 (CAL B): 0.77 - 1.15 mmol/LLevel 3 (CAL C): 1.67 - 2.00 mmol/LLevel 4 (CAL D): 3.35 - 3.85 mmol/LLevel 5 (CAL E): 5.12 - 5.89 mmol/L	Level 1: ≤ 0.20 mmol/LLevel 2: 0.80 - 1.00 mmol/LLevel 3: 1.71 - 1.89 mmol/LLevel 4: 3.42 - 3.78 mmol/LLevel 5: 5.22 - 5.78 mmol/L
Storage	Store at 2 - 8 °C.	Store at 2 to 8 °C.

J. Conclusion:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized emblem featuring an abstract representation of an eagle or bird-like figure.

10903 New Hampshire Avenue Silver Spring, MD 20993

NOV 04 2011

Siemens Healthcare Diagnostics c/o Rose T. Marinelli P.O. Box 6101 Newark, DE 19714

Re: K112142

Trade/Device Name: Dimension Vista® Lithium (LITH) Flex® Reagent Cartridge, Dimension Vista® Drug 4 Calibrator Regulation Number: 21 CFR 862.3560 Regulation Name: Lithium test system Regulatory Class: II Product Code: NDW, JIX Dated: October 4, 2011 Received: October 5, 2011

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.

If your device is classified (see above) into class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Pari 801), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

ﺴﻴﺔ

Sincerely yours.

. 17

Courtney H. Lias, Ph.D. 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 Form

510(k) Number (if known): K112142

Device Name: Dimension Vista® Lithium Flex® reagent cartridge, (LITH) K4150

Indications for Use: The LITH method is an in vitro diagnostic test for the quantitative measurement of lithium in human serum and plasma on the Dimension Vista® System. 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).

Device Name: Dimension Vista® Drug 4 Calibrator, (DRUG 4 CAL) KC460A

Indications for Use: The Drug 4 Calibrator is an in vitro diagnostic product for the calibration of the LOCI Digoxin (DIGXN) and Lithium (LITH) methods on the Dimension Vista® System.

Prescription Use V -----------------------------------------------------------------------------------------------------------------------------------------------------------

AND/OR

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

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Oude Chere

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 112142

Page 1 of 1

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.