ELECSYS CALLCHECK DIGOXIN by BOEHRINGER MANNHEIM CORP.

Elecsys® CalCheck™ DIGOXIN calibration verification solutions comprise three levels - low, mid, and high - each with a defined DIGOXIN concentration. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.

The Elecsys® CalCheck™ DIGOXIN is intended for use in periodic verification of the calibration of the Elecsys® DIGOXIN reagent.

Device Description

The Elecsys® CalCheck™ DIGOXIN is a three level single analyte set of stable liquid, bovine based materials. They are assayed in triplicate and the results compared to the target values.

AI/ML Overview

The provided document is a 510(k) summary for the Elecsys® CalCheck™ DIGOXIN, a calibration verification material. This type of device is used to check the calibration assignment of an in vitro diagnostic assay, not to produce diagnostic results directly from patient data. Therefore, the concepts of acceptance criteria as typically applied to diagnostic performance (e.g., sensitivity, specificity, AUC) and the detailed study elements you've requested (like sample size for test sets/training sets, expert ground truth, MRMC studies) are not directly applicable or are not detailed in this type of submission for this specific device.

Instead, the "performance" of such a device primarily relates to its ability to verify the calibration of the associated assay. The acceptance criteria would typically involve demonstrating that the CalCheck material, when run on the Elecsys® DIGOXIN assay, produces results that are consistent with its assigned target values, thereby verifying the assay's calibration over its measuring range.

Here's an attempt to address your questions based on the available information and the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in terms of ranges or tolerance limits for the CalCheck™ DIGOXIN material. However, its intended use implies that when tested, the measured values should fall within an acceptable range of its assigned target values.

Feature	Acceptance Criteria (Implied)	Reported Device Performance (Implied from Intended Use)
Primary Function	The Elecsys® CalCheck™ DIGOXIN should accurately verify the calibration assignment of the Elecsys® DIGOXIN assay.	The device is intended for use in periodic verification of the calibration of the Elecsys® DIGOXIN reagent. This implies it met performance expectations during validation.
Concentration Levels	Must comprise three distinct levels (low, mid, high) with defined DIGOXIN concentrations.	Low solution: near the lower detection limit. Mid solution: in the middle or at the clinically critical point. High solution: near the upper limit of the measuring range.
Stability	Must be a stable liquid material.	Described as a stable liquid, bovine-based material.
Matrix Type	Suitable for matrix match with the assay, or validated for its matrix effects.	Bovine serum (different from the predicate's horse serum, which was deemed acceptable).

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

This information is not provided in the 510(k) summary. For a calibration verification material, the "test set" would typically refer to the number of replicates or runs performed during the characterization and validation of the product, both for assigning its own values and for demonstrating its ability to verify the associated assay. The document states it is "assayed in triplicate," which likely refers to the method for determining its target values, but not necessarily the full validation sample size. The provenance of this data (e.g., country of origin) is also not specified. It is a Boehringer Mannheim product, likely developed and tested in a regulated environment relevant to its manufacturing locations.

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

This type of information is not applicable or not provided for a calibration verification material. The "ground truth" for such a device is typically its assigned concentration, which is determined through a rigorous analytical process using reference methods and materials, not by expert consensus in a clinical sense.

4. Adjudication Method for the Test Set

This is not applicable or not provided. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of clinical data, which is not the function of this device classification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that are interpreted by human readers (e.g., radiologists, pathologists) and aims to assess the impact of AI assistance on their performance. The Elecsys® CalCheck™ DIGOXIN is a laboratory reagent, not an imaging or interpretive diagnostic AI device, so such a study is not relevant to its function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device's function involves an "algorithm" in the sense of the chemical reaction and measurement process of the Elecsys® DIGOXIN assay, the concept of "standalone performance" as typically discussed for AI devices (algorithm only without human-in-the-loop performance) is not applicable here. The CalCheck material itself does not have an "algorithm" in that AI sense; its performance is linked to its assigned values and its interaction with the Elecsys® DIGOXIN assay.

7. The Type of Ground Truth Used

The "ground truth" for the Elecsys® CalCheck™ DIGOXIN is its assigned DIGOXIN concentration values. These values are established through an analytical process, likely calibrated against internationally recognized reference materials or methods to ensure accuracy and traceability. It is not based on expert consensus, pathology, or patient outcomes data, as these are clinical endpoints.

8. The Sample Size for the Training Set

This information is not applicable or not provided. The concept of a "training set" is relevant for machine learning algorithms that learn from data. This device is a chemical reagent, not a learning algorithm. Its "manufacture" involves established chemical and production processes, not data training.

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

This is not applicable as there is no "training set" in the context of this device. The assigned values of the CalCheck material (its "ground truth" for verification purposes) would be established through:

Reference methods.
Assaying against known primary standards.
Interlaboratory studies.
Statistical analysis of repeated measurements (e.g., "assayed in triplicate" mentioned in the description).

In summary, the provided 510(k) pertains to a calibration verification material, not a clinical diagnostic device that interprets patient data or uses AI. Therefore, many of the requested study details like test set size, expert consensus, MRMC studies, and training set information are not relevant or typically found in submissions for this class of product. The "study" that proves the device meets its acceptance criteria involves analytical validation demonstrating that the material performs as intended to verify the calibration of the associated Elecsys® DIGOXIN assay.

Summary

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NOV 트'4 1997

11-11-173

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510(k) Summary
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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.

1. Submitter name, address, contact	Boehringer Mannheim Corporation4300 Hacienda DrivePleasanton, CA 94588-2722(510) 730 - 8415Fax number: (510) 225 - 0654
	Contact Person: Jody J. SavageDate Prepared: October 17, 1997
2. Device Name	Proprietary name: Elecsys® CalCheck™ DIGOXINCommon name: Calibration Verification MaterialClassification name: Single (specified) analyte controls (assayed + unassayed)
3. Predicate device	The Elecsys® CalCheck™ DIGOXIN is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH (K963147).
4. Device Description	The Elecsys® CalCheck™ DIGOXIN is a three level single analyte set of stable liquid, bovine based materials. They are assayed in triplicate and the results compared to the target values.

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510(k) Summary, Continued

5.Intended use	The Boehringer Mannheim Elecsys CalCheck DIGOXIN is used to verify thecalibration assignment for the Boehringer Mannheim Elecsys DIGOXIN assay.
6.Comparison topredicate device	The Elecsys® CalCheck™ DIGOXIN is substantially equivalent to thecurrently marketed Elecsys® CalCheck™ TSH (K963147).The following table compares the Elecsys® CalCheck™ DIGOXIN with thepredicate devices, Elecsys® CalCheck™ TSH. Specific data on theperformance of the test have been incorporated into the draft labeling inattachment 5. Labeling for the predicate devices is provided in attachment 6.
	Similarities:
	• Configuration: Three CalCheck levels: low, mid, and high
	• Intended use: To verify calibration
	Differences:

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and the first of the first of the state of the state of the state of the state of the states and the states of the states of the states and

Feature	CalCheck DIGOXIN	CalCheck TSH
Matrix type	Bovine serum	Horse serum
Analyte	DIGOXIN	TSH

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with outstretched arms, overlaid with three horizontal lines that suggest movement or energy. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure, indicating the organization's name and country.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Jody J. Savage .Consultant, Regulatory Affairs Boehringer Mannheim 4300 Hacienda Drive 94588-2722 Pleasanton, California

NOV - 4 1997

Re : K973973 Elecsys® CalCheck™ DIGOXIN Requlatory Class: I Product Code: DMP October 17, 1997 Dated: Received: October 20, 1997

Dear Ms. Savage:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (chin oo), chip device maj uquifical you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asborized in 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours,
Steven Litman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Device Name: Elecsys® CalCheck™ DIGOXIN

Indications For Use:

The Elecsys® CalCheck™ DIGOXIN is intended for use in periodic verification of the calibration of the Elecsys® DIGOXIN reagent.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number	K973973
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Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use(Optional Format 1-2-96)
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Regulation Number and Section

§ 862.3280 Clinical toxicology control material.

(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general 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.