The Quantia Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or plasma (EDTA, Heparin, Citrate) on the Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation.

Quantia Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Quantia Lp(a) reagents by turbidimetry.

Quantia Lp(a) Standard is intended for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry.

Device Description

Quantia Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Quantia Lp(a) reagents by turbidimetry.

Quantia Lp(a) Standard is intended for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry.

AI/ML Overview

Here's an analysis of the provided text regarding the Quantia Lp(a) device, structured to address your specific points:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state pre-defined acceptance criteria for the Quantia Lp(a) device. Instead, it presents performance data and compares it to a predicate device to demonstrate substantial equivalence.

Performance Metric	Reported Device Performance (Quantia Lp(a) vs Predicate)	Implicit Acceptance Criteria (based on predicate equivalence)
Method Comparison
Slope	1.121	Close to 1 (indicating proportional agreement)
Correlation Coeff. (r)	0.9754	High (indicating strong linear relationship)
Within-run Precision (CV)
Control Level 1 (mean 16.1 mg/dL)	2.3%	Low CVs (indicating good reproducibility)
Control Level 2 (mean 57.9 mg/dL)	0.9%	Low CVs (indicating good reproducibility)
Control Level 3 (mean 38.1 mg/dL)	1.5%	Low CVs (indicating good reproducibility)

Study to Prove Device Meets Acceptance Criteria:

The study proving the device meets the implicit acceptance criteria is a method comparison study and within-run precision assessment, detailed in the "Summary of Performance Data" section.

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

Test Set Sample Size: 104 samples for the method comparison study.
Data Provenance: Not explicitly stated, but originating from Biokit S.A. in Spain. The study compares the Quantia Lp(a) device to a predicate device, which implies the 104 samples were run on both systems. The document doesn't specify if the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable. The "ground truth" for the method comparison study was established by the predicate device (K013128 N-latex Lp(a) from Dade Behring).
Qualifications of Experts: N/A, as expert consensus was not used to establish the ground truth.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. The comparison is directly to a predicate device, not against an adjudicated ground truth from multiple human readers.

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 study was not done. This device is an in-vitro diagnostic (IVD) assay, not an AI-powered image analysis tool or decision support system that would involve human readers.

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

Standalone Performance: Yes, the performance data presented (method comparison and precision) represents the standalone performance of the Quantia Lp(a) assay system, as it's an automated immunoturbidimetric assay. There is no "human-in-the-loop" component in the direct measurement process.

7. The type of ground truth used:

Type of Ground Truth: The "ground truth" for comparative effectiveness in this context is the results obtained from the predicate device, K013218 N-latex Lp(a) (Dade Behring).

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This document describes the validation of a laboratory assay, not a machine learning algorithm that requires a distinct training set. The assay's "training" or calibration would involve its own internal standards (Quantia Lp(a) Standard), not a separate dataset in the machine learning sense.

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

Ground Truth for Training Set: Not applicable in the machine learning sense. The Quantia Lp(a) Standard is used for establishing the calibration curve. The "ground truth" for these standards would have been established by the manufacturer through rigorous analytical methods (e.g., using reference materials and established metrological traceability) to determine their assigned values. This process is distinct from establishing ground truth for a machine learning training set.

Summary

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Kosoy487

APR 2 6 2005

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Section 3 Quantia Lp(a) 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

Biokit S.A. Can Male, Llissa d'Amunt Barcelona

08186 Spain

Contact Person:

Contact: Joan Guixer, Quality Assurance and Regulatory Affairs Director

Phone: 34 - 93 860 90 00

Summary Prepared:

February 15, 2005

Name of the device:

Quantia Lp(a)

Classification name(s):

Class II Low-density lipoprotein immunological test system 866.5600 DFC lipoprotein, low-density, antigen, antiserum, control

ldentification of predicate device(s):

K013128 N-latex Lp(a) (Dade Behring)

Description of the device/intended use(s):

Quantia Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Quantia Lp(a) reagents by turbidimetry.

Quantia Lp(a) Standard is intended for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry.

Statement of Technological Characteristics of the Device Compared to Predicate Device:

Quantia Lp(a) is substantially equivalent to the commercially available predicate device, N-latex Lp(a) (Dade Behring), in performance and intended use.

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L'050487
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Summary of Performance Data:

In a method comparison study evaluating 104 samples with Lp(a) levels ranging from 2.4 to 188 mg/dL on the Abbott AEROSET® instrument, the slope was 1.121 and the correlation coefficient (r) was 0.9754 for Quantia Lp(a) versus the predicate device.

Within run precision was assessed over multiple runs using three different levels of control: (Quantia Lp(a) controls I and II and a mixture of control I and control II) on an Abbott (Gaamille The precision assessed gave a CV of 2.3% (at a mean of 16.1 mg/dL) and 0.9% (at a mean of 57.9 mg/dL). The third control (control II) gave a CV of 1.5 % (at a mean of 38.1 mg/dL).

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Image /page/2/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 with its wings spread.

APR 2 6 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Joan Guixer Ouality Assurance &Regulatory Affairs Director Biokit S.A. Can Male Llissa D'Amunt Barcelona, Spain 08186

K050487 Trade/Device Name: Quantia Lp(a) Regulation Number: 21 CFR 866.5600 Regulation Name: Low-density lipoprotein immunological test system Regulatory Class: Class II Product Code: DFC, JIS, JJX Dated: February 22, 2005 Received: February 25, 2005

Dear Ms. Guixer:

Re:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth 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) 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 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,

Sean M. Cooper MS, DUM

Jean M. Cooper, MS, D.V.M. 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 Statement

510(k) Number (if known): K050481

Device Name: Quantia Lp(a)

Indications for Use:

The Quantia Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a]] concentration in human serum or plasma (EDTA, heparin, citrate) on Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation.

Quantia Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Quantia Lp(a) reagents by turbidimetry.

Quantia Lp(a) standard is intended for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry.

Prescription Use
(Part 21 CFR 801 Subpart D)

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)

ctay

(Division Sign-Off)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K050487

Regulation Number and Section

§ 866.5600 Low-density lipoprotein immunological test system.

(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).