The Sentinel Plasmaproteins Cal 3x is a device intended for medical purpose for use in ceruloplasmin, kappa light chains and lambda light chains assay to establish points of reference that are used in the determination of values in the measurement of ceruloplasmin, kappa and lambda light chains in human serum and plasma.

Device Description

Sentinel Plasmaproteins Cal 3x contains analytes (plasmaproteins) in human serum matrix. The analytes consist of ceruloplasmin, kappa light chains, and lambda light chains.

AI/ML Overview

The provided text describes Sentinel Plasmaproteins Cal 3x, a calibrator for ceruloplasmin, kappa light chain, and lambda light chain assays. The device's performance is primarily assessed through its calibrator shelf-life stability.

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria	Reported Device Performance
Calibrator Shelf-life Stability (% Recovery)	100 ± 10 %	Kappa light chains: 101.5% at 25 months; Lambda light chains: 99.2% at 25 months; Ceruloplasmin: 98.9% at 25 months.

2. Sample size used for the test set and the data provenance:

Sample size: One lot (lot P0387) of Plasmaproteins Cal 3x was used for the shelf-life stability study.
Data provenance: Not explicitly stated, but it's a prospective study since it involves storing the calibrator and testing it at different time points to determine shelf-life. The country of origin is not specified for the data collection itself, but the submitter is from Milan, Italy.

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 as the study is for the stability of a calibrator, not a diagnostic device requiring expert interpretation for ground truth. The 'ground truth' here is the assigned value at manufacturing, which is determined by a value assignment process, not expert consensus.

4. Adjudication method for the test set:

This is not applicable as the study does not involve expert review or adjudication of results. The 'ground truth' is the initial assigned value, and results are compared against this instrumental determination.

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 is not applicable. The device is a calibrator, not an AI-powered diagnostic tool, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

This is not applicable. The device is a calibrator, not an algorithm.

7. The type of ground truth used:

The ground truth for the stability study is the assigned value at manufacturing time. This value is established through a specific value assignment process (testing five replicates per three runs for each analyte, with the assigned value being the average of all replicates).

8. The sample size for the training set:

This is not applicable. The device is a calibrator, not a machine learning model, so there is no training set in the conventional sense.

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

This is not applicable, as there is no training set. The "ground truth" for the calibrator's value itself (the assigned value at manufacturing) is established by:

Testing the new lot.
Assessing five replicates per three runs for Kappa light chain, Lambda light chain, and Ceruloplasmin assays.
Calculating the assigned value as the average of all replicates for each assay.
Using quality control materials to verify assay performance and fresh reagents/new calibrations at each run.

Summary

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JUL 25 2005

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510(k) Summary

Submitter's Name/Address Sentinel CH. Srl Via Principe Eugenio 5 20155 Milan - ITALY

Contact Person Mr. Davide Spada Application Specialist +39 02 345514.1 Telephone: +39 02 345514.64 Facsimile: spada@sentinel.it E-Mail:

Date of Preparation of this Summary:	May 28, 2005
Device Trade or Proprietary Name:	Sentinel Plasmaproteins Cal 3x
Device Common/Usual Name or Classification Name:	Calibrator
Classification Number/Class:	JIX/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: _ KOS 1457

Test Description:

The Sentinel Plasmaproteins Cal 3x is a device intended for medical purposes for use in ceruloplasmin, kappa light chain, and lambda light chain assays to establish points of reference that are used in the determination of values in the measurement of ceruloplasmin, kappa light chains, and lambda light chains in human serum and plasma.

Intended Use:

Sentinel Plasmaproteins Cal 3x must be used only for the calibration of plasmaprotein tests using the immunoturbidimetric methods.

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Description of the Calibrator Material:

Sentinel Plasmaproteins Cal 3x contains analytes (plasmaproteins) in human Schumer i lasthup been
serum matrix. The analytes consist of ceruloplasmin, kappa light chains, and lambda light chains.

Assigned Values and Value Assignment Process:

The Sentinel Plasmaproteins Cal 3x value assignment is assessed by testing the new lot The belief.

In the assignment testing, five replicates per three runs are assessed for Kappa light in the assigninent as a Ceruloplasmin assays. The assigned value is calculated is as the average of all the replicates for each assay.

Quality control materials are used to verify the assay performance at every step of the test. Fresh reagents and new calibrations are used at each run.

Directions for Use:

Refer to Draft Calibrator Labeling

Performance Characteristics:

1. Precision/Reproducibility
  N/A

2. Linearity/assay reportable range

N/A

3. Traceability (controls, calibrators, or method)

The Sentinel Plasmaproteins Cal 3x is traceable to the following referenced standards:

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Short Name	Analyte	Method	Standardization
Cerul	Ceruloplasmin	Turbidimetric	CRM 470
Kappa	Kappa Light Chains	Turbidimetric	CRM 470
Lambd	Lambda Light Chains	Turbidimetric	CRM 470

4. Detection limit (functional sensitivity)

N/A

5. Analytical specificity

N/A

6. Assay cut-off

N/A

7. Calibrator Shelf-life Stability

The calibrator shelf-life stability was determined by the recovery method on one lot of Plasmaproteins Cal 3x stored at 2 – 8 °C, compared with the value assigned at manufacturing time. Percent recovery was calculated for each calibrator level by dividing the result in conventional units (mg/dL) of the test calibrators by the assigned value (mg/dL) and multiplying the result by 100. Acceptance criteria is 100 ± 10 %. At each testing point. Data support a shelf life of 25 months. Claim will be 24 months. Results are reported in the table below.

Plasmaproteins Cal 3xlot P0387	AssignedValue	Found1 Monthat 2-8 °C	% Rec	Found25 Monthsat 2-8 °C	% Rec
Kappa light chains (mg/dL)	590	592	100.3%	599	101.5%
Lambda light chains (mg/dL)	356	354	99.4%	353	99.2%
Ceruloplasmin (mg/dL)	90	90	100.0%	89	98.9%

Sentinel Plasmaproteins Cal 3x (510k) May 28, 2005

510(k) Summary Page 11

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by a series of curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 25 2005

Mr. Davide Spada Applicantion Specialist SENTINEL CH. S.r.l Via Principe Eugenio, 5 20155 Milano- Italy

K051457 Re:

Trade/Device Name: Sentinel Plasmaproteins Cal 3x Regulation Number: 21 CFR 862. 1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: May 28, 2005 Reccived: June 2, 2005

Dear Mr. Spada:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section > ro(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars) to regard the Medical Device Amendments, or to commerce pror to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug, devices that have been reclassined in above approval of a premarket approval application (PMA). alle Cosment Act (11ct) that do novice, subject to the general controls provisions of the Act. The I ou may, merelore, market the act include requirements for annual registration, listing of general controls provisions of aactice, 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 your device is etassified (oos as ontrols. Existing major regulations affecting your device it may be subject to Such additions (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 can be found in Ther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be davilsed that I termination that your device complies with other requirements of the Act that i Dri has made a and regulations administered by other Federal agencies. You must or any I citizal statutes and regarations ancluding, but not limited to: registration and listing (21 CirR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice OFF Part 007), accessed in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) This icher will anow you to ough maniesting of substantial equivalence of your device to a legally premarket notification: "The PDF I marks gification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, rr you desire specific information and advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the v mo Diagnostic De Moo Handing by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may oount only gonetic gonerational 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,

Carol C. Benson

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology 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): Kos 1457

Device Name:_Sentinel Plasmaproteins Cal 3x

Indications For Use:

The Sentinel Plasmaproteins Cal 3x is a device intended for medical purpose for use in
telled in the supportunity in and larged light absins assay to establish points of The Sentinel Plasmaprotents cal Jx is a device internation in establish points of
ceruloplasmin, kappa light chains and lambda light chains as annonement of ceruloplasmin, Rappa ligit thans and idination of values in the measurement of
reference that are used in the determination in humans serum and plasma reference that are used in the determination of values in and plasma.
ceruloplasmin, kappa and lambda light chains in human serum and plasma.

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

Over-The-Counter Use _ (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)

Division Sign Off) Division of Clinical Laboratory Dev 510(k) Number

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.