The Calibrator for Automated Systems (C.f.a.s.) consists of liquid human serum with biological materials added as required to obtain desired component levels. Values for constituent analytes are provided in product labeling.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called "Calibrator for Automated Systems (C.f.a.s.) Lipids." This document focuses on establishing substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in terms of performance metrics.

Here's an analysis based on the provided text, addressing your points where possible, and noting where information is not available:

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

The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., accuracy, precision, sensitivity, specificity) for the C.f.a.s. Lipids device itself. Instead, it focuses on demonstrating substantial equivalence to a predicate device, "Roche Diagnostic Calibrator for Automated Systems (C.f.a.s.) HDL/LDL-C plus (K974825)".

The "acceptance criteria" in this context are implicitly that the proposed device:

Shares the same intended use as the predicate.
Has similar features (format, stability, levels, matrix).
Differences in features (constituent analytes) do not raise new questions of safety or effectiveness.

Table of Substantial Equivalence Comparison (from the provided text):

Feature	C.f.a.s. Lipids (Proposed)	C.f.a.s. HDL/LDL-C plus (Predicate Device)
Intended Use	For use in the calibration of Roche lipid methods on automated clinical chemistry analyzers.	For use in the calibration of homogeneous Roche methods for the quantitative determination of HDL-cholesterol and LDL-cholesterol on automated clinical chemistry analyzers.
Format	Pooled human sera with constituents added as required to obtain component levels.	Pooled human sera with constituents added as required to obtain desired component levels.
Stability	Lyophilized calibrator at 2-8°C until expiration date. Reconstituted: 8 hours at 15-25°C, 5 days at 2-8°C, 1 month at -20°C.	Lyophilized calibrator at 2-8°C until expiration date. Reconstituted: 1 day at 15-25°C, 5 days at 2-8°C, 1 month at -20°C.
Levels	Single Level	Single Level
Matrix	Lyophilized	Lyophilized
Constituent Analytes	Apolipoprotein A1, Apolipoprotein B, Cholesterol, HDL-cholesterol, LDL-cholesterol, Phospholipids, Triglycerides	HDL-cholesterol, LDL-cholesterol

The "reported device performance" in this document is effectively the demonstration that the features and intended use are sufficiently similar to the predicate device, and where there are differences (e.g., additional analytes), these differences are acceptable for substantial equivalence. No specific numerical performance results (like accuracy percentages or coefficients of variation) for the new device are provided in this summary.

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

This information is not provided in the 510(k) summary. This type of summary focuses on the comparison of the device's characteristics with a predicate device, not on specific clinical or analytical studies that would involve test sets and data provenance. For a calibrator, studies typically involve testing its ability to consistently calibrate instruments across a range of values, but details of such studies are absent here.

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)

This information is not applicable and not provided. This device is a calibrator, not a diagnostic tool requiring expert interpretation of images or patient data to establish ground truth.

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

This information is not applicable and not provided. As a calibrator, it doesn't involve subjective interpretations that would require adjudication.

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

This information is not applicable and not provided. This device is a calibrator, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

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

This information is not applicable and not provided. This device is a chemical calibrator; it does not involve an algorithm in the sense of AI or image processing.

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

For a calibrator, the "ground truth" would typically be derived from highly accurate reference methods or certified reference materials used to assign target values to the calibrator vials. The document states that "Values for constituent analytes are provided in product labeling," implying that these values are established and accepted as accurate. However, the method for establishing this "ground truth" (e.g., using a traceability chain to a primary reference method) is not detailed in this summary.

8. The sample size for the training set

This information is not applicable and not provided. As a calibrator, there isn't a "training set" in the context of machine learning or classification algorithms.

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

This information is not applicable and not provided for the same reasons as point 8.

Summary

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K01658

JUL 3 1 2001

510(k) Summary

According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence.

Submitter name, address, contact

Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46250 (317) 576-7643

and the comments of the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the con

Contact Person: Helen T. Torney

Date Prepared: May 24, 2001

Device Name

Proprietary name: Calibrator for Automated Systems (C.f.a.s.) Lipids

Common name: C.f.a.s. Lipids

Classification name: Calibrator, Multi-analyte mixture

and the comments of the comments of the comments of the comments of

Device Description The Calibrator for Automated Systems (C.f.a.s.) consists of liquid human serum with biological materials added as required to obtain desired component levels. Values for constituent analytes are provided in product labeling.

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510(k) Summary, Continued

Intended use	For use in the calibration of Roche lipid methods on automated clinicalchemistry analyzers.
SubstantialEquivalence	The Calibrator for Automated Systems (C.f.a.s.) Lipids is substantiallyequivalent to other devices legally marketed in the United States. We claimequivalence to the Roche Diagnostic Calibrator for Automated Systems(C.f.a.s.) HDL/LDL-C plus (K974825). The intended use of both devices isthe establishment of calibration curves for their respective test systems.

Substantial equivalence similarities

The following table compares the Calibrator for Automated Systems (C.f.a.s.) Lipids with the predicate device.

Feature	C.f.a.s. Lipids	C.f.a.s. HDL/LDL-C plus(Predicate Device)
Intended Use	For use in the calibration ofRoche lipid methods onautomated clinical chemistryanalyzers.	For use in the calibration ofhomogeneous Roche methodsfor the quantitativedetermination of HDL-cholesterol and LDL-cholesterol on automatedclinical chemistry analyzers.
Format	Pooled human sera withconstituents added asrequired to obtain-component levels.	Pooled human sera withconstituents added as requiredto obtain desired componentlevels.
Stability	Stability of lyophilizedcalibrator at 2-8°C. untilexpiration date. Stability of reconstitutedcalibrator:8 hours at 15-25°C.5 days at 2-8°C.1 month at -20°C.	Stability of lyophilizedcalibrator at 2-8°C untilexpiration date. Stability of reconstitutedcalibrator:1 day at 15-25°C.5 days at 2-8°C.1 month at -20°C.
Levels	Single Level	Single Level
Matrix	Lyophilized	Lyophilized

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510(k) Summary, Continued

Substantial equivalence differences

Comparison of proposed Calibrator for Automated Systems (C.f.a.s.) Lipids and predicate device. .

Feature	C.f.a.s. Lipids	C.f.a.s. HDL/LDL-C plus(Predicate Device)
ConstituentAnalytes	Apolipoprotein A 1	HDL-cholesterol
	Apolipoprotein B	LDL-cholesterol
	Cholesterol
	HDL-cholesterol
	LDL-cholesterol
	Phospholipids
	Triglycerides

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 3 1 2001

Ms. Helen T. Torney Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road PO Box 50457 Indianapolis, IN 46250-0457

510(k) Number: K011658 Re: JTO(K) Nambor. 110. Calibrator for Automated Systems (C.f.a.s.) Lipids Regulation Number: 862.1150 Regulatory Class: II Product Code: JIX Dated: May 24, 2001 Received: May 29, 2001

Dear Ms. Torney:

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 to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device microlate commored pror to tray 20, 20, 2011, 2017 11:40 pm
Amendments, or to devices that have been reclassified in accordance with the provisions of the Amendinone, of to avrieosmetic Act (Act). You may, therefore, market the device, subject to r coolar Food, Brag, and Common the Act. The general controls provisions of the Act include the general of 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 regulations (1 remarket rippt of ally in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing i A substantially ogal rates and (GMP) regulation (21 CFR Part 820) and that, through I faction inspections, the Food and Drug Administration (FDA) will verify such penodio GMP mispections with the GMP regulation may result in regulatory action. In assumptions: T andre to oblight further announcements concerning your device in the Federal addition, I Dri may pather sesponse to your premarket notification submission does not affect reeister. Flease noter thave under sections 531 through 542 of the Act for devices under the ally obtigation you inight in Control provisions, or other Federal laws or regulations.

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Page 2

This letter will allow you to begin marketing your device as described in your 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 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, (Jease contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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Indications for Use Statement

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

Device Name: Calibrator for Automated Systems (C.f.a.s.) Lipids

Indications For Use:

For use in the calibration of Roche lipid methods on automated clinical chemistry analyzers.

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Joan Cooper
(Division ign-Off)
Division of Clinical Laboratory vices
510(k) Number KD11658

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.