The LOCI NTP CAL is an in vitro diagnostic product for the calibration of the Nterminal pro-brain natriuretic peptide (NTP Cat. No. RF623) method on the Dimension® EXL™ integrated chemistry system with LOCI® Module.

Device Description

AI/ML Overview

The provided document is a 510(k) summary for a calibrator device, not a diagnostic device that performs a clinical assessment. Therefore, the typical acceptance criteria and study designs described for diagnostic or AI-powered devices (such as sensitivity, specificity, MRMC studies, or multi-reader studies) are not applicable here.

The document primarily focuses on demonstrating substantial equivalence to an existing predicate device by comparing the product's features and intended use. The "performance" in this context refers to the calibrator's ability to provide accurate values for the calibration of a specific N-terminal pro-brain natriuretic peptide (NTP) method.

Here's an analysis based on the information provided, tailored to a calibrator device:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not explicitly state quantitative "acceptance criteria" in terms of performance metrics like accuracy, precision, or detection limits for the calibrator itself, as one might for a diagnostic assay. Instead, the primary "acceptance criterion" for this 510(k) submission is substantial equivalence to the predicate device.

Feature/Criterion	Predicate Device (Dimension Vista® PBNP Flex® Calibrator (KC676A))	Reported Performance (LOCI NTP CAL - RC623)	Notes/Comparison
Intended Use	Calibration of PBNP method on Dimension Vista® System.	Calibration of NTP method on Dimension® EXL™ integrated chemistry system with LOCI® Module.	Although the specific systems differ, the core intended use (calibration of similar analytes) is deemed substantially equivalent.
Analyte	Synthetic PBNP	Synthetic PBNP	Identical.
Matrix	Bovine Albumin	Bovine Albumin	Identical.
Form	Liquid, frozen	Liquid, frozen	Identical.
Volume	Ten vials, two vials per level (A, B, C, D, and E), 1.0 mL per vial.	Ten vials, two vials per level (A, B, C, D, and E), 1.0 mL per vial.	Identical.
Levels	Five Levels (0, 250, 1500, 12,000, 36,750 pg/mL)	Five Levels (0, 250, 1500, 12,000, 36,750 pg/mL)	Identical.
Overall Performance	Cleared under K080578, implying its performance met regulatory standards for a calibrator.	"Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance."	The submission asserts that the new device performs equivalently to the predicate based on unspecified "comparative testing." Details of this testing are not provided in the summary.

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

The document does not provide details on the sample size used for any "test set" in the traditional sense of evaluating a diagnostic algorithm. For a calibrator, "testing" would involve evaluating its stability, accuracy of assigned values, and its ability to properly calibrate the associated assay. The summary mentions "Comparative testing described in the protocol included in this submission," but no specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) are given for this testing.

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

This is not applicable for a calibrator device. Ground truth, in the context of clinical diagnostics, refers to definitive patient diagnoses or outcomes. For a calibrator, the "truth" is its assigned value, which is determined through a manufacturing and value assignment process, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set:

This is not applicable for a calibrator device. Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies among expert readers in diagnostic studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable as the device is a calibrator, not a diagnostic or AI-powered system that human readers would use or interact with.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable as the device is a calibrator, and there is no "algorithm" in the sense of a standalone diagnostic or interpretative system. Its performance is tied directly to its chemical and physical properties and its ability to correctly standardize an assay.

7. The Type of Ground Truth Used:

For a calibrator, the "ground truth" is its assigned value (e.g., specific concentrations of NTP). This is established through rigorous analytical methods (e.g., gravimetric preparation, reference methods, or comparison to established reference materials) during the manufacturing and value assignment process, not through expert consensus, pathology, or outcomes data in the clinical sense. The document states "Description of the manufacturing, value assignment and stability testing process are provided in this submission report," indicating that these processes define the "truth" of the calibrator.

8. The Sample Size for the Training Set:

This is not applicable. Calibrators are not "trained" like machine learning algorithms. Their properties are determined during manufacturing and quality control.

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

This is not applicable. There is no "training set" for a calibrator. The "truth" of its assigned values is established through the analytical and quality control processes mentioned above (manufacturing, value assignment, stability testing).

Summary

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OCT 1 0 2008

510(k) Summary of Safety and Effectiveness for the Dimension® EXL™ LOCI® NTP Calibrator (RC623)

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.

Ko82680

B. Date of Preparation: August 26, 2008

C. Proprietary and Established Names:

Dimension® EXL™ LOCI N-terminal Pro-Brain Natriuretic Peptide Calibrator (LOCI NTP Calibrator - RC623)

D. Applicant:

A. 510(k) Number: _

Siemens Healthcare Diagnostics Inc., P.O. Box 6101, Newark, DE 19714-6101 Victor M. Carrio, Senior Manager, Regulatory Affairs Office: (302) 631-0376 Fax: (302) 631-6299

E. Regulatory Information:

1. Regulation section: 21 CFR § 862.1150 Calibrator, Secondary
1. Classification: Class II
1. Product Code: JIT, Calibrator, Secondary
1. Panel: Clinical Chemistry

F. Predicate Device:

The LOCI NTP Calibrator (RC623) is substantially equivalent to the Dimension Vista® PBNP Calibrator (KC676A) cleared under K080578.

G. Device Description:

The LOCI NTP CAL is a frozen liquid product containing synthetic human N-terminal pro-brain natriuretic peptide in bovine albumin matrix with stabilizers and preservative. The kit consists of ten vials, two vials per level (A, B, C, D, and E), 1.0 mL per vial. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.

H. Intended Use:

I. Substantial Equivalence Information:

The LOCI NTP Calibrator (RC623) and the predicate Dimension Vista® PBNP Calibrator (KC676A) were compared. A comparison of the important similarities and differences between the devices and the predicates is provided in the following table:

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Feature	LOCI NTP CAL	Dimension Vista® PBNP Flex®Calibrator (KC676A)(K080578)
IntendedUse	The LOCI NTP CAL is an in vitrodiagnostic product for the calibrationof the N-terminal pro-brain natriureticpeptide (NTP Cat. No. RF623)methods on the Dimension® EXL™integrated chemistry system withLOCI® Module.	The PBNP CAL is an in vitrodiagnostic product for the calibrationof the N-Terminal Pro-BrainNatriuretic Peptide (PBNP) method forthe Dimension Vista® System.
Analyte	Synthetic PBNP	Synthetic PBNP
Matrix	Bovine Albumin	Bovine Albumin
Form	Liquid, frozen	Liquid, frozen
Volume	Ten vials, two vials per level (A, B, C,D, and E), 1.0 mL per vial.	Ten vials, two vials per level (A, B, C,D, and E), 1.0 mL per vial.
Levels	Five Levels, (0, 250, 1500, 12,000,36,750 pg/mL)	Five Levels, (0, 250, 1500, 12,000,36,750 pg/mL)

J. Conclusion:

The Dimension® EXL™ LOCI N-terminal Pro-Brain Natriuretic Peptide Calibrator (RC623) is substantially equivalent to the predicate Dimension Vista® PBNP Calibrator (KC676A) cleared under K0080578. Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle-like emblem with three stylized lines forming its body and wings. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A.", arranged in a circular fashion around the emblem.

Public Health Service

OCT 1 0 2008

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Siemens Healthcare Diagnostics, Inc. c/o Mr. Victor Carrio Senior Manager of Regulatory Affairs P.O. Box 6101, Mail Stop 514 Newark, DE 19714-6101

Re: K082680

Trade Name: LOCI N-Terminal Pro-Brain Natriuretic Peptide Calibrator (RC623) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIT Dated: September 12, 2008 Received: September 15, 2008

Dear Mr. Carrio:

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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Page 2 -

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.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please not 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 Division of Small Manufacturers, International and Consumer Assistance at its tollit the (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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Indication for Use

K 7 8 2 6 8 3 510(k) Number (if known):

Device Name:

LOCI N-Terminal Pro-Brain Natriuretic Peptide Calibrator (RC623)

Indication For Use:

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Benson

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

510(k) K082680

Page 1 of 1

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.