The Sentinel Ceruloplasmin assay is used for the quantitation of ceruloplasmin (copper-transporting serum protein) levels in human serum or plasma. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorder.

Device Description

Sentinel Ceruloplasmin is an in vitro diagnostic assay for the quantitative determination of ceruloplasmin in serum or plasma. The Sentinel Ceruloplasmin assay is a two-reagent format based on the immunological reaction between anti-ceruloplasmin antibonds specific for ceruloplasmin. The turbidity of the immunocomplex is proportional to the concentration of the analyte in the sample.

AI/ML Overview

Here's an analysis of the provided text regarding the Sentinel Ceruloplasmin assay, broken down according to your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Sentinel Ceruloplasmin)
Method Correlation (Slope)	Close to 1.0 (indicating good agreement)	1.0256
Method Correlation (Y-intercept)	Close to 0 (indicating no systematic bias)	-1.0205 mg/dL
Total %CV (Precision) - Level 1	Comparable to predicate (not explicitly stated, but generally <10% for clinical assays)	3.69%
Total %CV (Precision) - Level 2	Comparable to predicate	5.33%
Total %CV (Precision) - Level 3	Comparable to predicate	4.53%
Linearity (Upper Limit)	At least comparable to predicate assay	Up to 110 mg/dL
Limit of Quantitation (Sensitivity)	At least comparable to predicate assay	2 mg/dL

Study Proving Device Meets Acceptance Criteria:

The study conducted to prove the device meets the acceptance criteria is a comparative performance study against a legally marketed predicate device, the Roche Ceruloplasmin assay on the Roche/Hitachi 911 Analyzer. This study focused on demonstrating substantial equivalence in performance characteristics.

Detailed Information about the Study:

Test Description: "Sentinel Ceruloplasmin is an in vitro diagnostic assay for the quantitative determination of ceruloplasmin in serum or plasma."
Substantial Equivalence Claim: "The Sentinel Ceruloplasmin assay is substantially equivalent to the Roche Ceruloplasmin assay (which was exempted from the Premarket Notification) on the Roche/Hitachi 911 Analyzer (Previously named Boehringer Mannheim Hitachi 911 Analyzer, K921661). These assays yield similar Performance Characteristics."
Study Execution: "Comparative performance studies were conducted using the AEROSET® System."

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

Sample Size for Test Set: The document does not explicitly state the sample size used for the comparative performance study or the precision studies.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the nature of in vitro diagnostic device studies, it's typically prospective data collected in a controlled laboratory setting, but this is not confirmed in the text.

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

This information is not applicable to this type of device and study. The "ground truth" for this in vitro diagnostic assay is established by the direct measurement of ceruloplasmin concentration using the predicate device, not by expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable to this type of in vitro diagnostic device study. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology studies where multiple readers interpret images to establish a consensus ground truth). Here, the comparison is between two quantitative assays.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers and is relevant for AI-powered diagnostic tools, not for a standalone in vitro diagnostic assay like Sentinel Ceruloplasmin.
Effect Size of AI Improvement: This is not applicable as there is no AI component or human-in-the-loop scenario described for this device.

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

Yes, a standalone performance study was done. The "comparative performance studies" and "precision studies" evaluate the Sentinel Ceruloplasmin assay as a standalone device, comparing its quantitative results directly to the predicate device's quantitative results. There is no human interpretation or human-in-the-loop component mentioned.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the Sentinel Ceruloplasmin assay was the results obtained from the legally marketed predicate device, the Roche Ceruloplasmin assay on the Roche/Hitachi 911 Analyzer. This is considered a "reference method" or "comparator" for establishing substantial equivalence.

8. The Sample Size for the Training Set

The document does not mention a training set. This is because the Sentinel Ceruloplasmin assay is a traditional in vitro diagnostic device (immunological reaction leading to turbidity measurement), not a machine learning or AI-based algorithm that requires a training set.

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

This question is not applicable as there is no training set for this traditional in vitro diagnostic device.

Summary

{0}------------------------------------------------

OCT 2 1 2005

510(k) Summary

Submitter's Name/Address Sentinel CH. S.r.l. via Principe Eugenio, 5 20155 Milan, Italy

Contact Person Davide Spada Application Specialist +39 02 345514.1 Fax +39 02 345514.64

Date of Preparation of this Summary:	August 30, 2005
Device Trade or Proprietary Name:	Sentinel Ceruloplasmin
Device Common/Usual Name or Classification Name:	ceruloplasmin
Classification Number/Class:	JFR/Class II

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Test Description:

Substantial Equivalence:

The Sentinel Ceruloplasmin assay is substantially equivalent to the Roche Ceruloplasmin assay (which was exempted from the Premarket Notification) on the Roche/Hitachi 911 Analyzer (Previously named Boehringer Mannheim Hitachi 911 Analyzer, K921661). These assays yield similar Performance Characteristics.

Page 2 of 4

{1}------------------------------------------------

Similarities:

Both assays are in vitro clinical chemistry methods. .
Both assays can be used for the quantitative determination of analyte name. .
Both assays yield similar clinical results. .
Both assays have the same reference range. .

Differences:

There is a difference between the assay ranges.

Intended Use:

The Sentinel Ceruloplasmin assay is used for the quantitation of ceruloplasmin in serum or plasma.

Performance Characteristics:

Comparative performance studies were conducted using the AEROSET® System. The Sentinel Ceruloplasmin assay method comparison yielded acceptable correlation with the Roche Ceruloplasmin assay on the Roche/Hitachi 911 Analyzer. The Passing & Bablok regression was: slope = 1.0256, and Y-intercept = -1.0205 mg/dL. Precision studies were conducted using the Sentinel Ceruloplasmin assay. Within-run and between-run studies were performed using three levels of control material. The total %CV for Level 1 is 3.69%, Level 2 is 5.33%, and Level 3 is 4.53%. The Sentinel Ceruloplasmin assay is linear up to 110 mg/dL. The limit of quantititation (sensitivity) of the Sentinel Ceruloplasmin assay is 2 mg/dL. These data demonstrate that the performance of the Sentinel Ceruloplasmin assay is substantially equivalent to the performance of the Roche Ceruloplasmin assay on the Roche/Hitachi 911 (Previously named Boehringer Mannheim Hitachi 911 Analyzer, K921661). S

{2}------------------------------------------------

Conclusion:

The Sentinel Ceruloplasmin assay is substantially equivalent to the Roche Ceruloplsmin assay on the Roche/Hitachi 911 Analyzer as demonstrated by results obtained in the studies.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Sentinel CH. S.r.l. c/o Mr. Davide Spada Application Specialist Via Principe Eugenio, 5 20155 Milano, Italy

OCT 2 1 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: K051456

Trade/Device Name: Sentinel Ceruloplasmin Regulation Number: 21 CFR 866.5210 Regulation Name: Ceruloplasmin Immunological Test System Regulatory Class: Class II Product Code: JFR Dated: May 28, 2005 Received: June 2, 2005

Dear Mr. Spada:

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.

{4}------------------------------------------------

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,

Robert Beckerh

Robert L. Becker, Jr., MD, PAD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

510(k) Number (if known): 长 0514576

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 801 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)

Marie Chan
Division Sign-Off

Office of In Vitro Diagne Device Evaluation and So

510(k) ko51456

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 866.5210 Ceruloplasmin immunological test system.

(a)
Identification. A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.(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 § 866.9.