The provided document is a 510(k) summary for the Elecsys LH CalSet II, a calibrator. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, this is a calibrator, not a diagnostic device that performs clinical measurements or applies an algorithm to patient data. Therefore, the typical acceptance criteria and study designs outlined in your request (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, ground truth types) do not apply in the context of this specific device.

Instead, for a calibrator, the "acceptance criteria" and "study" would relate to its ability to accurately and consistently calibrate assays, its stability, and its equivalence to the predicate calibrator. The provided document focuses on demonstrating substantial equivalence based on intended use, matrix, storage form, levels, standardization, and stability compared to the predicate.

Here's how we can interpret your request in the context of this calibrator:

1. Table of acceptance criteria and the reported device performance:

Since this is a calibrator, the "acceptance criteria" revolve around its functional equivalence and performance characteristics compared to the predicate device.

Acceptance Criteria (Implied for Calibrator Equivalence)	Reported Device Performance (Elecsys LH CalSet II)
Intended Use: For calibrating the quantitative LH assay on Elecsys immunoassay systems.	Intended Use: "The Elecsys LH CalSet II is used for calibrating the quantitative LH assay on the Elecsys immunoassay systems." (Matches predicate's broader intended use, adapting to newer systems implied).
Matrix: Suitable for LH calibration.	Matrix: Human serum matrix (predicate used "Buffer/protein matrix"). While different, this is presented as an acceptable modification for the calibrator.
Storage form: Stable for intended use.	Storage form: Lyophilized (predicate was liquid). This is a different form but acceptable if stability is demonstrated.
Levels: Provides appropriate low and high calibration points (approx. 1 mIU/mL and 45 mIU/mL).	Levels: Same as predicate ("Low: approx. 1 mIU/mL; High: approx 45 mIU/mL").
Standardization: Calibrated against recognized international standard (NIBSC 80/552).	Standardization: Same as predicate ("Calibrated against 2nd International Standard (NIBSC) 80/552").
Stability: Maintains integrity over specified storage conditions and duration.	Stability: - Lyophilized: up to expiration date (at 2-8°C).- Reconstituted: 1 month at -20°C (freeze only once).- Onboard: use only once.(These are different from the predicate's stability profiles but are the claimed performance for the new form).

2. Sample size used for the test set and the data provenance:

Not Applicable. For a calibrator, "test set" in the sense of patient data for diagnostic algorithm validation is not relevant. The studies conducted would involve testing the calibrator's performance characteristics (e.g., accuracy, precision, stability) on the Elecsys immunoassay system. The document does not specify the number of calibration runs, batches, or instruments tested.
Data provenance: Not specified in this 510(k) summary. Given it's a Roche product, internal validation data would be expected.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. As this is a calibrator, there is no "ground truth" established by experts in the clinical sense (e.g., diagnosing a condition). The "truth" for a calibrator relates to its assigned values being traceable to an international standard.

4. Adjudication method for the test set:

Not Applicable. No clinical test set requiring expert adjudication is involved for this device.

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:

Not Applicable. This is a calibrator, not an AI-powered diagnostic device. MRMC studies are not relevant.

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

Not Applicable. This is a calibrator, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Standardization against International Standard. For a calibrator, the "ground truth" for its assigned values is established through traceability to internationally recognized standards. The document states: "Calibrated against 2nd International Standard (NIBSC) 80/552." This ensures consistency across different assays and laboratories.

8. The sample size for the training set:

Not Applicable. Calibrators do not have "training sets" in the context of machine learning.

9. How the ground truth for the training set was established:

Not Applicable. Calibrators do not have "training sets."

Summary

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K031299

MAY 12 2003

510(k) Summary - Elecsys LH CalSet II

Introduction	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence
Submitter name, address, contact	Roche Diagnostics Corporation9115 Hague RdIndianapolis IN 46250(317) 521-3831Contact person: Theresa M. AmbroseDate prepared: April 24, 2003
Device Name	Proprietary name: Elecsys LH CalSet IICommon name: CalibratorClassification name: Calibrator, secondary
Device description	Elecsys LH CalSet II consists of a lyophilized human serum matrix with added LH.
Intended use	The Elecsys LH CalSet II is used for calibrating the quantitative LH assay on the Elecsys immunoassay systems.
Predicate Device	We claim substantial equivalence to the currently marketed Elecsys LH CalSet . (K964694).

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510(k) Summary -- COBAS Integra Creatinine plus ver.2,

continued

The following table compares the Elecsys LH CalSet II and the predicate Reagent Summary device.

Topic	LH CalSet (K964694)	LHCalSet II (Modified Device)
Intended Use	The Elecsys LH CalSet is usedfor calibrating the quantitativeLH assay on the Elecsys1010/2010 and MODULARANALYTICS E170immunoassay system.	The Elecsys LH CalSet II is used forcalibrating the quantitative LH assayon the Elecsys immunoassay systems.
Matrix	Buffer/ protein matrix	Human serum matrix
Storage form	Liquid	Lyophilized
Levels	Low: approx. 1 mIU/mLHigh: approx 45 mIU/mL	Same
Standardization	Calibrated against 2ndInternational Standard (NIBSC)80/552	Same
Stability	Unopened at 2-8°C: up toexpiration dateAfter opening, in aliquots: 12weeks at 2-8°COnboard 2010/1010 (20-25 °C):up to 5 hours totalE170: use only once	Store at 2-8°CLyophilized calibrators : up toexpiration dateReconstituted: at -20 °C: 1 month(freeze only once)On board: use only once

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three curved lines representing its wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 2 2003

Theresa M. Ambrose, Ph.D., FACB Regulatory Principle, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

Re: K031299

Trade/Device Name: Elecsys LH CalSet II Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: April 24, 2003 Received: May 1, 2003

Dear Dr.Ambrose:

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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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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): N/A

Device Name: Elecsys LH CalSet II

Indications For Use:

The Elecsys LH CalSet II is used for calibrating the quantitative LH assay on the Elecsys immunoassay systems.

Lan Coogs.

(Division Sign-Off)
Division of Clinical Laborator
510(k) Number K031299.

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Concurrence of CDRH, Office of Device Evaluation (ODE) い Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

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.