ROCHE DIAGNOSTICS ELECSYS AFP CALSET II by ROCHE DIAGNOSTICS CORP.

The provided text describes a 510(k) summary for the "Elecsys® AFP CalSet II" device, which is a calibrator for an immunoassay system. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy for diagnosing conditions.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Elecsys® AFP Calset, K981282) by comparing their intended use, matrix, storage form, levels, standardization, and stability.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an analysis based on the information provided:

1. A table of acceptance criteria and the reported device performance

Not Available: The document does not specify acceptance criteria for clinical or analytical performance metrics (e.g., accuracy, precision, bias) for the calibrator itself. The comparison table focuses on the characteristics of the calibrator device and its predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Available: The document describes a calibrator and its characteristics, not a diagnostic test with a "test set" in the traditional sense of patient samples. Therefore, no information on sample size or data provenance for a test set is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable/Not Available: This question is relevant for diagnostic devices that interpret patient data, where expert review is used to establish ground truth for a test set. This document describes a calibrator; therefore, this information is not relevant or provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable/Not Available: As with point 3, this is not relevant for a calibrator 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 document describes a calibrator, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related information is provided.

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

Not Applicable: This is a calibrator, not an algorithm, so a standalone performance study is not relevant.

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

Not Applicable: The concept of "ground truth" in the context of diagnostic accuracy for patient samples does not apply to a calibrator itself. The calibrator is standardized against a reference standard (1st IRp WHO reference standard 72/225), which serves as its "truth" for concentration determination.

8. The sample size for the training set

Not Applicable/Not Available: This information pertains to machine learning models, which are not described in the context of this calibrator product.

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

Not Applicable/Not Available: See point 8.

Summary

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NOV 2 3 2004

K043095

510(k) Summary - Elecsys® AFP 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 Diagnostics9115 Hague RdIndianapolis IN 46250(317) 521-3544Contact person: Kay A. TaylorDate prepared: November 8, 2004
Device Name	Proprietary name: Elecsys® AFP CalSet IICommon name: CalibratorClassification name: Calibratory, secondary
Device description	The Elecsys® AFP CalSet II consists of a lyophilized human serum matrix with added AFP in two concentrations.
Intended use	The Elecsys AFP CalSet II is used for calibrating the quantitative AFP assay on the Elecsys immunoassay systems.
Predicate Device	We claim substantial equivalence to the currently marketed Elecsys® AFP Calset. (K981282).

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510(k) Summary - Elecsys® AFP CalSet II, continued

Reagent Summary The following table describes the similarities and differences between the Elecsys® AFP CalSet II and the Elecsys AFP CalSet.

Topic	Elecsys® AFP CalSet(K981282)	Elecsys® AFP CalSet II(Modified Device)
Intended Use	The Elecsys AFP CalSet is used for calibrating the quantitative AFP assay on the Elecsys immunoassay systems.	The Elecsys AFP CalSet II is used for calibrating the quantitative AFP assay on the Elecsys immunoassay systems.
Matrix	Buffer	Human serum
Storage Form	Liquid	Lyophilized
Levels	Low: approx. 5-6 ng/mlHigh: approx. 50-60 ng/ml	Same
Standardization	Standardized against the 1st IRp WHO reference standard 72/225.	Same
Stability	12 wks at 2-8°C:20-25°C:	6 wks at 2-8°C:6 wks at -20°C: (freeze once)20-25°C:
	up to 5 hours on 1010/2010use only once on E170	up to 5 hours on 1010/2010use only once on E170

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The text is in all caps and is relatively small compared to the caduceus symbol.

Public Health Service

NOV 2 3 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms Kay Taylor MT (ASCP), RAC Regulatory Program Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

Re: K043095

Trade/Device Name: Roche Diagnostics Elecsys® AFP CalSet II Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: November 8, 2004 Received: November 9, 2004

Dear Ms Taylor:

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.

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Page 2 -- Ms Kay Taylor

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-3084. 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,

H.M. Beaty

Robert L. Becker, Jr, M.D., PhD Director Division of Immunology and Hematology Devices

Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

K43095 510(k) Number (if known): N/A

Device Name: Elecsys® AFP CalSet II

Indications For Use:

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

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

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

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)(21 CFR 807 Subpart C) Over-The-Counter Use

Maria In Chan

Dideler, Clerk-Off

Islon Slan-

Office of In Vitro Diagno ice Evaluation and Safety

510(k) K043095

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.