The Quantia A1-AT is intended for the in vitro quantitative determination of alpha-1-antitrypsin concentration in human serum or plasma (heparin with or without gel separator, EDTA) on the AEROSET® system as an aid in the diagnosis of juvenile and adult cirrhosis of the liver and pulmonary emphysema.

Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia A1-AT reagents by turbidimetry. (NOTE: This control has been also FDA 510(k) submitted for use with Quantia Beta-2 Microglobulin). For in vitro diagnostic use.

Quantia PROTEINS standard is intended for use in establishing the calibration curve for the Quantia A1-AT reagents by turbidimetry. For in vitro diagnostic use.

Device Description

The Quantia A1-AT is intended for the in vitro quantitative determination of alpha-1-antityypsin concentration in human serum or plasma (heparin with or without gel separator, EDTA) on the AEROSET® system as an aid in the diagnosis of juvenile and adult cirrhosis of the liver and pulmonary emphysema.

Quantia PROTEINS standard is intended for use in establishing the calibration curve for the Quantia A1-AT reagents by turbidimetry. For in vitro diagnostic use.

AI/ML Overview

Here's an analysis of the provided text regarding the Quantia A1-AT device, structured to answer your questions about acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance

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

Performance Metric	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Quantia A1-AT)
Method Comparison	Substantially equivalent to predicate device (N Antisera to Human alpha-1-Antitrypsin). Implies acceptable correlation, slope, and intercept.	Slope: 1.002 (vs. predicate device)
		Correlation Coefficient (r): 0.9890 (vs. predicate device)
Precision (CV%) - Low Control	Acceptable precision for clinical use (specific thresholds not stated, but implied by predicate equivalence).	Within Run: 1.2%
		Between Run: 0.2%
		Total: 1.4%
Precision (CV%) - Control (I + II)	Acceptable precision for clinical use.	Within Run: 0.7%
		Between Run: 0.1%
		Total: 0.8%
Precision (CV%) - High Control	Acceptable precision for clinical use.	Within Run: 1.3%
		Between Run: 0.6%
		Total: 1.8%

Note on Acceptance Criteria: The document primarily focuses on demonstrating "substantial equivalence" to a predicate device. For in-vitro diagnostic devices like this, substantial equivalence means demonstrating that the new device is as safe and effective as a legally marketed predicate device. This typically involves showing comparable performance across key metrics. The specific numerical acceptance criteria (e.g., minimum 'r' value, maximum CV%) are not explicitly stated in the summary but are implied by the successful demonstration of substantial equivalence and the comparison to the predicate. The provided performance data (slope, correlation, precision) would have met the FDA's unstated, but understood, thresholds for equivalence.

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

Sample Size (Test Set): 111 samples
Data Provenance: Not explicitly stated. The submitting company (Biokit S.A.) is located in Barcelona, Spain. It's not clear from this summary if the samples themselves were from Spain, generated in specific clinical settings, or their origin. It is also not specified if the study was retrospective or prospective.

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 device is an in-vitro diagnostic test for quantitative determination of alpha-1-antitrypsin concentration. The "ground truth" in this context is established by the predicate device's measurement and the assigned values of control materials, not by expert human interpretation of images or other subjective assessments.
Therefore, the concept of "experts" to establish ground truth as described in the prompt (e.g., radiologists) is not applicable here. The comparison is made against the performance of an established, legally marketed device (N Antisera to Human alpha-1-Antitrypsin) and standardized control materials with known A1-AT levels.

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

Not applicable. This is not a study involving human interpretation or adjudication of cases. The comparison is between the quantitative results of two different assay methods (the new device vs. the predicate 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an automated in-vitro diagnostic test, not an AI-assisted diagnostic tool that would involve human readers.

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

Yes, the performance study effectively represents a "standalone" assessment of the device's accuracy and precision. The "method comparison study" directly compares the results of the Quantia A1-AT system (algorithm/reagents only) to the predicate device's results. The precision studies also evaluate the device in isolation, without human-in-the-loop performance influencing the measurement itself.

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

The "ground truth" for the method comparison study was the results obtained from the predicate device (N Antisera to Human alpha-1-Antitrypsin). For the precision studies, the ground truth was the known, assigned values of the control materials (Low Control, Control (I + II), High Control).

8. The sample size for the training set

The document does not mention a separate "training set." For an in-vitro diagnostic device like this, the development process (which would include internal validation and optimization) would involve various samples, but a distinct "training set" in the machine learning sense is not typically described in 510(k) summaries for such devices unless AI/ML is a core component, which is not the case here. The 111 samples described were for the performance evaluation (test set) to demonstrate equivalence.

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

Not applicable, as a distinct "training set" in the context of an AI/ML system with its associated ground truth establishment is not mentioned or relevant for this type of device. The device's calibration and performance would be based on established reference materials and comparison to a predicate, rather than a "training set" with expert-derived ground truth.

Summary

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

K050596

Section 3 Quantia A1-AT 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

MAY 1 3 2005

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 24, 2005

Name of the device:

Quantia A1-AT

Classification name(s):

866.5130	Alpha-1-antitrypsin immunological test system
DEM	Alpha-1-Antitrypsin, Antigen, Antiserum, Control

Class II

ldentification of predicate device(s):

N Antisera to Human alpha-1-Antitrypsin (Dade Behring) K860894

Description of the device/intended use(s):

Quantia PROTEINS standard is intended for use in establishing the calibration curve for the Quantia A1-AT reagents by turbidimetry. For in vitro diagnostic use.

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

Statement of Technological Characteristics of the Device Compared to Predicate Device: Quantia A1-AT is substantially equivalent to the commercially available predicate device, N Antisera to Human alpha-1-Antitrypsin, in performance and intended use.

Summary of Performance Data:

In a method comparison study evaluating 111 samples with alpha-1-antitrypsin levels ranging from 42.0 to 442.5 mg/dL on the Abbott AEROSET® instrument, the slope was 1.002 and the correlation coefficient (r) was 0.9890 for Quantia A1-AT versus the predicate device.

The studies performed on the Abbott AEROSET® system with Quantia A1-AT reagents support the following precision claims:

Material	Samples/Runs	Mean(mg/dL)	CV(%)Within Run	CV(%)BetweenRun	CV(%)Total
Low Control(I)	2/40	77.7	1.2	0.2	1.4
Control (I + II)	2/40	156.9	0.7	0.1	0.8
High Control(II)	2/40	229.7	1.3	0.6	1.8

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

Public Health Service

Food and Drug Administrati 2098 Gaither Road Rockville MD 20850

MAY 1 3 2005

Biokit S.A. c/o Ms. Joan Guixer Llissa d'Amunt Barcelona, Spain 08186

Re: K050596

Trade/Device Name: Quantia A1-AT Quantia Proteins Control Quantia Proteins Standard Regulation Number: 21 CFR 866.5130 Regulation Name: Alpha 1-antitrypsin Immunological Test System Regulatory Class: Class II Product Code: DEM, JJS, JJX

Dear Ms. Guixer:

Dated: February 24, 2005 Received: March 8, 2005

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.

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

Page 2 - Ms. Joan Guixer

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 premated 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) 276-0131. 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,

Robert A. Becker/

Robert L. Becker, Jr., M.D., Ph2 Director

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

Enclosure

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

Indications for Use Statement

510(k) Number (if known): K050596

Device Name: Quantia A1-AT

Indications for Use:

Quantia PROTEINS standard is intended for use in establishing the calibration curve for the Quantia A1-AT reagents by turbidimetry. For in vitro diagnostic use.

Prescription Use × (Part 21 CFR 801 Subpart D) 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)

Maria M Chan

Division Slan-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K020596

Regulation Number and Section

§ 866.5130

Alpha -1-antitrypsin immunological test system.(a)
Identification. Analpha -1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition,alpha -1-antitrypsin deficiency has been associated with pulmonary emphysema.(b)
Classification. Class II (performance standards).