LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L

K121084 · Siemens Healthcare Diagnostics, Inc. · JJX · May 9, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121084
• Device Name: LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: May 9, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

LCTNI CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias in the quantitative determination of cardiac troponin-I (CTNI/TNI) on the Dimension Vista® System and Dimension® EXL™ integrated chemistry system with LOCI® module. LCTNI CON M is an assayed, mid level, intralaboratory quality control for assessment of precision and analytical bias in the quantitative determination of cardiac troponin-I (CTNI/TNI) on the Dimension Vista® System and Dimension® EXL™ integrated chemistry system with LOCI® module. LCTNI CON H is an assayed, high level, intralaboratory quality control for assessment of precision and analytical bias in the quantitative determination of cardiac troponin-I (CTNI/TNI) on the Dimension Vista® System and Dimension® EXL™ integrated chemistry system with LOCI® module.

Device Story

LOCI Cardiac Troponin-I Controls (Low, Medium, High) are liquid, frozen, human serum-based quality control materials containing native human cardiac troponin complex. Used in clinical laboratory settings to monitor the performance of the Dimension Vista and Dimension EXL integrated chemistry systems. The controls are processed by laboratory personnel alongside patient samples to verify the accuracy and precision of the cardiac troponin-I assay. By comparing measured control values against established target ranges, clinicians identify potential analytical bias or precision issues, ensuring the reliability of patient test results used for cardiac assessment.

Clinical Evidence

No clinical data. Bench testing only, including validation of traceability, value assignment, stability, and matrix effects.

Technological Characteristics

Liquid, frozen, human serum-based quality control material. Contains native human cardiac troponin complex. Three levels (low, medium, high). Packaged in 2.2 mL vials. Designed for use with Dimension Vista and Dimension EXL integrated chemistry systems utilizing the LOCI module.

Indications for Use

Indicated for use as an assayed, intralaboratory quality control material to assess precision and analytical bias in the quantitative determination of cardiac troponin-I on Siemens Dimension Vista and Dimension EXL integrated chemistry systems.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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K.121084

# 510(k) Summary of Safety and Effectiveness for the LOCI Cardlac Troponin-I Control (Low, Medium and High) (KC681, KC682, and KC683)

MAY - 9 2012

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.02.

### A. 610(k) Number:

#### B. Date of Proparation: April 5, 2012

## C. Proprietary and Established Names:

LOCI Cardlac Troponin-I Control (low), LCTNI CON L (KC881) LOCI Cardiac Troponin-I Control (medium), LCTNI CON M (KC682) LOCI Cardiac Troponin-I Control (high), LCTNI CON H (KC683)

### D. Applicant:

Siemens Healthcare Diagnostics Inc., P.O. Box 6101, Newark, DE 19714-6101 Prances A. Dillon, Sr. Manager. Regulatory Affairs Tel: [phone] Fax: [phone]

### E. Regulatory Information:

- 1. Regulation Section: 21 CFR § 862.1660 Quality Control Material (Assayed and Unassayed)
- 2. Classification: Class I, reserve
- Product Code: JJX Single (Specified) Analyte Controls (Assayed and Unassayed) જં
- Panel: Clinical Chemistry ব

#### F. Predicate Device:

The predicate device used to demonstrate substantial equivalence is the Abbott ARCHITECT STAT Troponin-I Controls, cleared under K041194.

#### G. Device Description:

#### LOCI Cardlac Troponin-I Control (low), LCTNI: CON L

LCTNI CON L is a liquid, frozen, low level, human serum based product containing native human cardiac troponin complex. LCTNI CON L is packaged as 12 vials containing 2.2 mL quality control material per vial.

### LOCI Cardiac Troponin-I Control (medium), LCTNI CON M

LCTNI CON M is a liquid, frozen, mid level, human serum based product containing native human cardlac troponin complex. LCTNI CON M is packaged as 12 vials containing 2.2 mL quality control material per vial.

#### LOCI Cardiac Troponin-I Control (high), LCTNI CON H

LCTNI CON H is a liguid, frozen, high level, human serum based product containing native human cardlac troponin complex. LCTNI CON H is packaged as 12 vials containing 2.2 mL quality control material per vial.

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### H. Intended Use:

# LOCI Cardiac Troponin-I Control (low). LCTNI CON L

LCTNI CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias in the quantitative determination of cardiac troponin-I (CTNI/TNI) on the Dimension Vista® System and Dimension® EXL™ integrated chemistry system with LOCI® module.

## LOCI Cardiac Troponin-I Control (medium), LCTNI CON M

LCTNI CON M is an assayed, mid level, intralaboratory quality control for assessment of precision and analytical bias in the quantitative determination of cardiac troponin-J (CTNI/TNI) on the Dimension Vista® System and Dimension® EXL™ integrated chemistry system with LOCI® module.

### LOCI Cardiac Troponin-I Control (high), LCTNI CON H

LCTNI CON L is an assayed, high level, intralaboratory quality control for assessment of precision and analytical bias in the quantitative determination of cardiac troponin-I (CTNI/TNI) on the Dimension Vista® System and Dimension® EXL™ integrated chemistry system with LOCI® module.

### l. Substantial Equivalence Information:

The LOCI Cardiac Troponin-I Control (Low, Medium and High) was compared to the predicate device, Abbott ARCHITECT STAT Troponin-I Controls, cleared under K041194. The following tables provide a comparison of the important similarities and differences between the devices:

| Feature | New Device<br>LOCI Cardiac Troponin-I<br>Control L, M and H | Predicate<br>ARCHITECT STAT Troponin-I<br>Controls, K041194 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | LCTNI CON L, M and H are<br>assayed, intralaboratory quality<br>controls for assessment of<br>precision and analytical bias in<br>the quantitative determination of<br>cardiac troponin-I (CTNI/TNI)) on<br>the Dimension Vista® System<br>and Dimension® EXLTM<br>integrated chemistry system with<br>LOCI® module. | The ARCHITECT STAT Troponin-<br>Controls are for verification of the<br>accuracy and precision of the<br>ARCHITECT i System with STAT<br>protocol capability when used for<br>the quantitative determination of<br>cardiac troponin-l (cTnl) in<br>human serum and plasma. |
| Product Code | JJX | JJX |
| Assayed<br>Control | Yes | Yes |
| Constituents | Native human cardiac troponin<br>complex | Recombinant human cardiac<br>troponin IC complex |
| Matrix | Human serum | BES buffer |
| Form | Liquid, frozen | Liquid, frozen |
| Levels<br>Available | Three - L, M and H | Three - L, M and H |
| Package<br>Configuration | 12 vials x 2.2 mL per vial.<br>One level per carton | 6 vials x 3.0 mL each level;<br>2 x 3 x 3.0 mL, 2 vials of each<br>level. |

#### Similarities and Differences

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# J. Performance:

The traceability, value assignment, stability and matrix effects of the LOCI Cardiac Troponin-I Control L, M and H have been validated following procedures of Siemens Healthcare Diagnostics, Inc.

# K. Conclusion:

LOCI Cardiac Troponin-I Control (low), LOCI Cardiac Troponin-I Control (medium) and LOCI Cardiac Troponin-I Control (high) are substantially equivalent in design and intended use to the previously cleared Abbott ARCHITECT STAT Troponin-I Controls (K041194).

.

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10903 New Hampshire Avenue Silver Spring, MD 20993

Siemens Healthcare Diagnostics, Inc c/o Frances A. Dillon P.O. Box 6101 Mailstop 514 Newark, Delaware 19714-6101

JUN - 1 2012

k121084 Re:

Trade Name: LOCI Cardiac Troponin-I Control (Low), LCTN1 Con L LOCI Cardiac Troponin-I Control (Medium), LCTNI CON M LOCI Cardiac Troponin-I Control (High), LCTNI CON H Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, Reserved Product Codes: JJX Dated: April 6, 2012 Received: April 10, 2012

Dear Ms. Dillon:

This letter corrects our substantially equivalent letter of May 9, 2012.

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section 510(x) promise is substantially equivalent (for the referenced above and have determined the do readly marketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed prodicel Douice indications for use stated in the enclosers, to he enactment date of the Medical Device interstate comments, or to way 20, 1270, and encordance with the provisions of
Amendments, or to devices that have been reclassified in accordance approvel of a premarket Amendments, or to devices that have been for at require approval of a premarket.
the Federal Food, Drug, and Cosmetic Act (Act) that do will as and contract the Federal Food, Drug, and Cosment Act (rice) that device, subject to the general
approval application (PMA). You may, therefore, market the det include approval application (1 MA). Tou may, more on ontrols provisions of the Act include controls provisions of the Act. The general of devices, good manufacturing practice, requirements for aniled rogginst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III
n affectived (see and the same the cases of the Esisting major regulations affec If your device is classified (sec additional controls. Existing major regulations affecting
(PMA), it may be subject to such additional CERS (CEP), Parts 800 to 895 (PMA), if may be subject to such additional controls. "CFR), Parts 800 to 895.
your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to Bederal your device can be found in Thie 21, Code of Poderal Regeralises (1) (1) = )
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 Please be advised that FDA S Issualice of a socures with other requirements
mean that FDA has made a determination that your device with other Federal agencies mean that FDA has made a decemination that your and instreed by other Federal agencies.
of the Act or any Federal statutes and regulations and not limited to: registration of the Act or any rederal statues and reginations, but not limited to: registration
You must comply with all the Act step of the Read 800) medical device You must comply with an the Act Sieques on the Act 801 and 809); medical device and listing (21 CFR 802); and oc and listing (21 CFR Fall 607), laboring (21 CFR 803); and good reporting (reporting of medical device-related adverse overling (S) regulation (21 CFR Part 820).

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# Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro 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/Medical

Devices/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 [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

N.

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices 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):

Device Name: LOCI Cardiac Troponin-I Control (Iow), LCTNI CON L LOCI Cardiac Troponin-I Control (medium), LCTNI CON M LOCI Cardiae Troponin-I Control (high), LCTNI CON H

### Indications for Use:

LOCI Cardiac Troponin-I Control (low), LCTNI CON L LCTNI CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical blas in the quantitative determination of cardiac troponin-l (CTNVTNI) on the Dimension Vista® System and Dimension® EXL ™ integrated chemistry system with LOCI® module.

LOCI Cardiac Troponin-I Control (medium), LCTNI CON M LCTNI CON M is an assayed, mid level, intralaboratory quality control for assessment of precision and analytical bias in the quantitative determination of cardiac troponin-l (CTNI/TNI) on the Dimension Vista@ System and Dimension® EXL ™ integrated chemistry system with LOCI® module.

LOCI Cardiac Troponin-I Control (high), LCTNI CON H LCTNI CON H is an assayed, high level, intralaboratory quality control for assessment of precision and analytical bias in the quantitative determination of cardiac troponin-l (CTNI/TNI) on the Dimension Vista® System and Dimension® EXL ™ integrated chemistry system with LOCI® module.

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 OF NEEDED)

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

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

510(k) ve 121084

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