The provided text is a 510(k) summary for the LOCI Thyroid Calibrator, a medical device for in vitro diagnostics. It outlines the device's description, intended use, and a comparison to a predicate device. However, it does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes for training/test sets, ground truth establishment, or expert involvement.

The document refers to "pre-defined acceptance criteria" in the stability section for the predicate device, but it does not specify what those criteria are or present any study data demonstrating compliance for the new device. The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo performance studies with detailed acceptance criteria and clinical validation.

Therefore, I cannot complete the requested tables and information based on the provided text, as the necessary details are absent.

To illustrate what would be provided if the information were available, here's a conceptual structure.

Conceptual Structure if Information was Present:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance	Meets Criteria?
FT4L Calibration	Specific values for accuracy, precision, linearity, and stability for FT4L calibration would be listed here.	Study results for accuracy, precision, linearity, and stability for FT4L calibration would be listed here.	Yes/No based on comparison
TSHL Calibration	Specific values for accuracy, precision, linearity, and stability for TSHL calibration would be listed here.	Study results for accuracy, precision, linearity, and stability for TSHL calibration would be listed here.	Yes/No based on comparison
Stability (e.g., 18 months)	Defined limits for deviation from initial values over the specified shelf-life.	Observed deviation over the specified shelf-life.	Yes/No based on comparison

2. Sample Sizes and Data Provenance

Test Set Sample Size: [Number of samples/patients]
Data Provenance (Test Set): [e.g., Country, Retrospective/Prospective, Type of samples (e.g., patient samples, spiked samples, reference materials)]
Training Set Sample Size: [Number of samples/patients]

3. Ground Truth Establishment for Test Set

Number of Experts: [Number]
Qualifications of Experts: [e.g., "Clinical chemists with 10+ years of experience in thyroid hormone analysis," or "Board-certified endocrinologists."]
Adjudication Method: [e.g., "Consensus discussion," "2-out-of-3 majority vote," "None, single expert determination."]

4. MRMC Comparative Effectiveness Study

Was an MRMC study done? [Yes/No]
Effect Size (if Yes): [e.e., "Human readers showed an X% improvement in diagnostic accuracy with AI assistance compared to without."]

5. Standalone Performance Study

Was a standalone study done? [Yes/No]
If Yes: The values in the performance table above would typically reflect standalone performance.

6. Type of Ground Truth Used

For Test Set: [e.g., "Reference method values from an independent lab," "Established true values of spiked samples," "Consensus of expert clinical assessment."]
For Training Set: [e.g., "Reference method values," "Manufacturer's internal reference materials."]

7. How Ground Truth for Training Set was Established

[Description of the process, e.g., "Using validated reference methods and commercially available reference materials with certified values," "Internal expert review and consensus."]

Based on the provided text alone, the following is all that can be extracted:

Device Name: LOCI Thyroid Calibrator
Intended Use: Calibration of FT4L and TSHL methods on the Dimension® EXL™ with LM system.
Predicate Device: LOCI Thyroid Calibrator (K073604)
Key difference from Predicate: The new device also calibrates the TSHL method and contains human thyroid stimulating hormone, and has an additional calibrator level (Level 2).
Stability Mention: "The stability of the calibrators is established through real-time data on 3 lots of product. Testing is conducted at multiple time points and must pass pre-defined acceptance criteria." (This refers to the predicate device in the comparison table, but implies similar processes for the new device without detailing specific criteria or results).
Traceability (New Device): Traceable to an internal master pool for FT4 and to the WHO standard for TSH.

Conclusion: The provided 510(k) summary is for a diagnostic calibrator and primarily focuses on demonstrating substantial equivalence. It does not include the detailed performance study results, acceptance criteria, or ground truth establishment information typically found in submissions for AI-powered diagnostic devices or other medical devices requiring extensive clinical validation against specific performance metrics.

Summary

{0}------------------------------------------------

510(k) Summary of Safety and Effectiveness LOCI Thyroid Calibrator

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation

Siemens Healthcare Diagnostics Inc. Manufacturer: P.O. Box 6101 Newark, DE 19714

Contact Information: Siemens Healthcarc Diagnostics Inc. P.O. Box 6101 Newark, DE 19714 Attn: Yuk-Ting Lewis Tel: 302-631-7626

Date of Preparation: April 14, 2008

2. Devicc Name / Classification

LOC1 Thyroid Calibrator / 21 CFR 862.1150 / Class 11

Identification of the Predicate Device 3.

LOCI Thyroid Calibrator, K073604

4. Device Description

The LOCI Thyroid Calibrator is a liquid, bovine serum albumin based product containing thyroid stimulating hormone and thyroxine. The calibrator levels and their assigned values are:

	evel	.Level 3	LA MARKELevel	Level	Level
135 11The Property of the Production of the Property of the Production of the Production of the Production of the Production of the Property of Property of Property of Property of		ng	noC- 24 ----A minimum a come of the a fine of the of the of the of the one of the one of the county	ng	no/i-
. TEU'		.1877	4,555	ﺎ ﮐﺎ00	--------

{1}------------------------------------------------

ട്. Device Intended Use

The LOCI Thyroid Calibrator is an in vitro diagnostic product for the calibration of the FT4L and TSHL methods on the Dimension® EXL™ with LM system.

.b Medical device to which equivalence is claimed and comparison information

The LOCI Thyroid Calibrator is substantially equivalent to the calibrator previously cleared under K073604. The LOCl Thyroid Calibrator contains human thyroid stimulating hormone and thyroxinc for calibrating the Dimension® TSHL and FT4L methods.

Feature	Predicate Device:LOCI Thyroid Calibrator	New Device:LOCI Thyroid Calibrator
Intended Use	The LOCI Thyroid Calibrator isused to calibrate theDimension® FT4L method onthe Dimension® EXL™ withLM system.	The LOCI Thyroid Calibrator isused to calibrate theDimension® FT4L and TSHLmethods on the Dimension®EXLT™ with LM system.
Analyte and Matrix	The LOCI Thyroid Calibratorcontains thyroxine in a bovineserum albumin matrix.	The LOCI Thyroid Calibratorcontains human thyroidstimulating hormone andthyroxine in a bovine serumalbumin matrix.
Form	The calibrators are in liquid form.
Calibrator levels	The LOCI Thyroid Calibratorkit contains Levels 3 through 6.	The LOCI Thyroid Calibratorkit contains Levels 2 through 6.Levels 3 through 6 are used tocalibrate the FT4L method.Levels 2 through 6 are used tocalibrate the TSHL method.
Stability	The stability of the calibrators is established through real-time dataon 3 lots of product. Testing is conducted at multiple time pointsand must pass pre-defined acceptance criteria.
Traceability	The calibrator is traceable to aninternal master pool for FT4.	The calibrator is traceable to aninternal master pool for FT4 andto the WHO standard for TSH.

{2}------------------------------------------------

Image /page/2/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 eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 3 2008

Siemens Healthcare Diagnostics, Inc. c/o Yuk-Ting Lewis P.O. Box 6101, M/S 514 Newark, DE 19714

Re: K081103 Trade/Device Name: LOCI Thyroid Calibrator Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: May 13, 2008 Received: May 14, 2008

Dear Ms. Lewis:

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).

{3}------------------------------------------------

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 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 Division 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

{4}------------------------------------------------

Indication for Use

510(k) Number (if known): < 08 | | 0 3

Device Name: LOCI Thyroid Calibrator

Indications For Use:

The LOCI Thyroid Calibrator is an in vitro diagnostic product for the calibration of the FT4L and TSHL methods on the Dimension® EXL™ with LM system.

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) K081103

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.