The Elecsys® CA 19-9 CalCheck™ is intended for use in the verification of the calibration established by the Elecsys® CA 19-9 reagent on the Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.

Device Description

The Elecsys® CA 19-9 CalCheck™ is a lyophilized product consisting of CA 19-9 in a buffered human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.

AI/ML Overview

The provided document describes the Elecsys® CA 19-9 CalCheck™ and its substantial equivalence to a predicate device. However, it does not contain the detailed performance study information requested in your prompt. This document is a 510(k) summary submitted to the FDA, which typically focuses on demonstrating substantial equivalence to a legally marketed device rather than detailing extensive performance studies with specific statistical acceptance criteria and ground truth establishment methods.

The "Performance Characteristics" section simply states: "The Elecsys® CA 19-9 CalCheck™ was evaluated for value assignment and stability." This is a very high-level statement and lacks the specifics you are looking for.

Therefore, for your request, I can only provide the information that is present in the document.

Missing Information:

The document does not provide the following details:

A table of acceptance criteria and reported device performance (beyond the general statement that it was "evaluated").
Sample size used for the test set.
Data provenance (country of origin, retrospective/prospective).
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size with AI assistance.
Specific details of a standalone (algorithm only) performance study.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
Sample size for the training set.
How the ground truth for the training set was established.

Information Available from the Document:

Here's what can be extracted from the provided text, related to the device and its intended use:

Device: Elecsys® CA 19-9 CalCheck™
Intended Use: For use in the verification of the calibration established by the Elecsys® CA 19-9 reagent on the Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.
Performance Evaluation: The device "was evaluated for value assignment and stability."

Because the requested granular details regarding acceptance criteria, study design, ground truth, and sample sizes for performance evaluations are not present in the provided 510(k) summary, I cannot fill in the table or answer most of your specific questions. Regulatory submissions for diagnostic controls often focus on demonstrating that the control material performs as expected in terms of its assigned values and stability, rather than extensive clinical efficacy or reader studies like those for AI-powered diagnostic devices.

Summary

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K 051185

510(k) Summary

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 Diagnostics9115 Hague RoadIndianapolis, IN 46250317-521-3723
	Contact Person: Corina Harper
	Date Prepared: May 6, 2005
Device Name	Proprietary name: Elecsys® CA 19-9 CalCheck™
	Common name: CA 19-9 CalCheck
	Classification name: Single (specified) analyte controls (assayed and unassayed)
Predicate device	The Elecsys® CA 19-9 CalCheck™ is substantially equivalent to the currently marketed Elecsys® C-Peptide CalCheck™ (K040157).
Device Description	The Elecsys® CA 19-9 CalCheck™ is a lyophilized product consisting of CA 19-9 in a buffered human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
Intended use	Elecsys® CA 19-9 CalCheck™ is intended for use in the verification of the calibration established by the Elecsys® CA 19-9 reagent on the Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.
	Continued on next page

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510(k) Summary, Continued

Comparison topredicatedevice	The Elecsys® CA 19-9 CalCheck™ is substantially equivalent to thecurrently marketed Elecsys® C-Peptide CalCheck™ (K040157). The belowtables compare Elecsys® CA 19-9 CalCheck™ with the predicate device,Elecsys® C-Peptide CalCheck™ (K040157).
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Similarities

Characteristic	Elecsys® CA 19-9CalCheck™	Predicate deviceElecsys® C-PeptideCalCheck™
Intended Use	Elecsys® CA 19-9CalCheck™ is intendedfor use in the verificationof the calibrationestablished by theElecsys® CA 19-9reagent on the Elecsys®1010/2010/MODULARANALYTICS E170immunoassay analyzers.	Elecsys® C-PeptideCalCheck is intended foruse in the verification ofthe calibration establishedby the Elecsys® C-Peptidereagent on the Elecsys®immunoassay systems.
Levels	Three	same
Format	Lyophilized	same
Handling	Reconstitute with exactly1.0 mL distilled ordeionized water andallow standing closed for15 minutes, then mixinggently.	same
Stability	Unopened:• Store at 2-8°C untilexpiration dateReconstituted:• 20 - 25°C : 4 hrs	same

Continued on next page

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510(k) Summary, Continued

Differences

Characteristic	Elecsys® CA 19-9CalCheck™	Predicate deviceElecsys® C-PeptideCalCheck™
Matrix	Human serum with addedCA 19-9	Buffered horse serum withadded C-Peptide

Performance	The Elecsys® CA 19-9 CalCheck™ was evaluated for value assignment and
Characteristics	stability.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circle around the caduceus symbol.

Public Health Service

JUL 6 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Roche Diagnostics Corp. c/o Ms Corina Harper 9115 Hague Rd. Indianapolis, IN 46250

Re: K051185

Trade/Device Name: Elecsys CA 19-9 CalCheck Regulation Number: 21 CFR 866.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: May 6, 2005 Received: May 9, 2005

Dear Ms Harper:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 -

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) 276-0484. 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/industry/support/index.html

Sincerely yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, Director Division of Immunology and Hematology 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): __K051185

Device Name:_Elecsys® CA_19-9 CalCheck™

Indications For Use:

Maria Chen

Division Sign-Off

Office of In Vitro Diagne Device Evaluation and Sately

510(k) K'o.s.j.i.l.s

Prescription Use XX = __

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

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

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.