DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE

• K Number: K112142
• Device Name: DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
• Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS
• Date Cleared: 2011-11-04 ( 101 days)
• Product Code: NDW JIX
• Regulation Number: 862.3560

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.

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.

Predicate Devices

K011033, K011035

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a chemical reaction-based assay and a calibrator, with no mention of AI or ML technologies.

Therapeutic

No.
This device is an in vitro diagnostic test for measuring lithium levels, which helps assure proper drug dosage but does not directly treat a patient.

Diagnostic

Yes
The "Intended Use" section explicitly states that the LITH method is an "in vitro diagnostic test" used for the quantitative measurement of lithium to assure proper drug dosage in patients with mental disturbances. The "Drug 4 CAL" is also described as an "in vitro diagnostic product for the calibration" of this method.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a chemical reaction involving a chromoionophore and a liquid calibrator, indicating a hardware-based in vitro diagnostic test and associated calibrator, not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use/Indications for Use: The very first sentence explicitly states, "The LITH method is an in vitro diagnostic test..." and "The Drug 4 CAL is an in vitro diagnostic product...". This is the most direct confirmation.
• Device Description: The description details how the test works by analyzing a sample (human serum and plasma) outside of the body ("in vitro") to measure a substance (lithium).
• Purpose: The purpose is to provide quantitative measurements of lithium in human samples to aid in the treatment of patients with mental disturbances. This is a diagnostic purpose.
• Calibrator: The description of the Drug 4 Calibrator also identifies it as an "in vitro diagnostic product" used for calibrating the LITH method.

All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnostic, monitoring, or screening purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

NDW, JIX

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.

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.

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

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Comparative testing described in the submission report demonstrates substantial equivalent performance.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K011033, K011035

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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: [phone]; Fax Number: [phone]

E. Regulatory Information:

Lithium (LITH) Flex® Reagent Cartridge:

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

Drug 4 Calibrator:

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

1

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.

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.

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:

2

| Feature | Dimension Vista® Lithium (LITH)
K4150 | Predicate: Dimension® Lithium (LI)
K011033 - DF132 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 LI method used on the Dimension®
clinical chemistry systems is an in vitro
diagnostic test intended to quantitatively
measure lithium in human serum and
plasma (sodium heparin). 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). |
| Sample Type | Serum and Sodium Heparin Plasma | Serum and Sodium Heparin Plasma |
| Measuring
Range | 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 vitro
diagnostic product for the calibration of
the LOCI Digoxin (DIGXN) and
Lithium (LITH) methods on the
Dimension Vista® System. | The Drug 1 CAL is an in vitro
diagnostic product for the calibration
of 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. |
| Target
Concentrations | Level 1 (CAL A): ≤ 0.20 mmol/L
Level 2 (CAL B): 0.77 - 1.15 mmol/L
Level 3 (CAL C): 1.67 - 2.00 mmol/L
Level 4 (CAL D): 3.35 - 3.85 mmol/L
Level 5 (CAL E): 5.12 - 5.89 mmol/L | Level 1: ≤ 0.20 mmol/L
Level 2: 0.80 - 1.00 mmol/L
Level 3: 1.71 - 1.89 mmol/L
Level 4: 3.42 - 3.78 mmol/L
Level 5: 5.22 - 5.78 mmol/L |
| Storage | Store at 2 - 8 °C. | Store at 2 to 8 °C. |

J:

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.

3

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: [phone]; Fax Number: [phone]

E. Regulatory Information:

Lithium (LITH) Flex® Reagent Cartridge:

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

Drug 4 Calibrator:

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

4

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 nm) 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 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:

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:

5

| Feature | Dimension Vista® Lithium (LITH)
K4150 | Predicate: Dimension® Lithium (LI)
K011033 - DF132 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 LI method used on the Dimension®
clinical chemistry systems is an in vitro
diagnostic test intended to quantitatively
measure lithium in human serum and
plasma (sodium heparin). 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). |
| Sample Type | Serum and Sodium Heparin Plasma | Serum and Sodium Heparin Plasma |
| Measuring
Range | 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 vitro
diagnostic product for the calibration of
the LOCI Digoxin (DIGXN) and
Lithium (LITH) methods on the
Dimension Vista® System. | The Drug 1 CAL is an in vitro
diagnostic product for the calibration
of 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. |
| Target
Concentrations | Level 1 (CAL A): ≤ 0.20 mmol/L
Level 2 (CAL B): 0.77 - 1.15 mmol/L
Level 3 (CAL C): 1.67 - 2.00 mmol/L
Level 4 (CAL D): 3.35 - 3.85 mmol/L
Level 5 (CAL E): 5.12 - 5.89 mmol/L | Level 1: ≤ 0.20 mmol/L
Level 2: 0.80 - 1.00 mmol/L
Level 3: 1.71 - 1.89 mmol/L
Level 4: 3.42 - 3.78 mmol/L
Level 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.

6

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.

7

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 [phone]. 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 [phone]. 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 [phone] 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

8

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

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