Quantia IqE is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of Immunoglobulin E concentration in human serum or plasma (EDTA, heparin, citrate) on the AEROSET System. Measurement of IgE is useful in the clinical diagnosis of IgE-mediated allergies, if used in conjunction with other clinical studies.

Quantia Ferritin / Myoglobin / IgE control is intended for use in monitoring the quality control of results obtained with Quantia Ferritin, Quantia Myoglobin and Quantia IgE reagents by turbidimetry. (NOTE: These controls were previously FDA cleared for use with quantex Ferritin, reference K040879 and also cleared for use with quantex Myoglobin K042982). For in vitro diagnostic use.

Quantia IgE Standard is intended for use in establishing the calibration curve for the Quantia IgE reagents by turbidimetry. For in vitro diagnostic use.

Device Description

Quantia IgE is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of Immunodobulin E concentration in human serum or plasma (EDTA, heparin, citrate) on the AEROSET System. Measurement of IgE is useful in the clinical diagnosis of IgE-mediated allergies, if used in conjunction with other clinical studies.

Quantia Ferritin / Myoglobin / IgE control is intended for use in monitoring the quality control of results obtained with the Quantia Ferritin, the Quantia Myoglobin and the Quantia IgE reagents by turbidimetry. (NOTE: These controls were previously FDA cleared for use with quantex Ferritin. reference K040879 and also cleared for use with quantex Myoglobin K042982) For in vitro diagnostic use.

Quantia IgE Standard is intended for use in establishing the calibration curve for the Quantia IgE reagents by turbidimetry. For in vitro diagnostic use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Quantia IgE device based on the provided text:

Acceptance Criteria and Reported Device Performance

The document implies acceptance criteria by demonstrating substantial equivalence to the predicate device. The key performance indicators used for this determination are related to method comparison and precision.

Acceptance Criteria (Implied)	Reported Device Performance
Method Comparison: Good correlation with predicate device (Quantia IgE vs. UniCAP Total IgE Fluoroimmunoassay)	Slope: 0.9650
	Correlation Coefficient (r): 0.9750
Precision (Within-run): Low Coefficient of Variation (CV)	CV at 47.3 IU/mL: 6.4 %
	CV at 406.5 IU/mL: 0.7 %
	CV at 228.4 IU/mL (Control I + Control II): 1.0 %

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: 101 samples
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved evaluating IgE levels ranging from 10 to 2269 IU/mL. It is likely retrospective, comparing an existing set of samples against two different assays.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of in vitro diagnostic device study. The "ground truth" for the method comparison is the measurement obtained from the predicate device.
Adjudication method for the test set:
- Not applicable. This is a quantitative assay comparison, not an interpretation-based study requiring adjudication.
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, an MRMC comparative effectiveness study was not done. This is an in vitro diagnostic device measuring a biomarker, not an imaging or interpretive AI system involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this study represents a standalone performance evaluation of the Quantia IgE assay (an algorithm in the sense of an automated test system) as it directly measures IgE levels and compares them to a predicate device without human intervention in the measurement process itself.
The type of ground truth used:
- For the method comparison study, the measurement obtained from the UniCAP Total IgE Fluoroimmunoassay (K964152) was used as the reference or "ground truth" for comparison. The precision study used known control materials.
The sample size for the training set:
- Not applicable as this is not a machine learning / AI model that requires a discrete training set. The "training" for such a system would involve the assay's development and optimization, which isn't described in terms of a specific data set size here.
How the ground truth for the training set was established:
- Not applicable for the reason stated above.

Summary

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Koso493

AUG 1 6 2005

Section 3 Quantia IgE 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:

June 29, 2005

Name of the device:

Quantia IgE

Classification name(s):

866.5510 Immunoqlobulins A, G, M, D and E immunological test system Class II DGC IgE, Antigen, Antiserum, Control

ldentification of predicate device(s):

K964152 UniCAP Total IgE Fluoroimmunoassay (Pharmacia)

Description of the device/intended use(s):

Quantia IgE Standard is intended for use in establishing the calibration curve for the Quantia IgE reagents by turbidimetry. For in vitro diagnostic use.

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

Quantia IgE is substantially equivalent to the commercially available predicate device, Quantia Tg= 16 Oabstantian) Sessay (Pharmacia), in performance and intended use.

Summary of Performance Data:

In a method comparison study evaluating 101 samples with IgE levels ranging from 10 to 2269 Il /mL on the Abbott AEROSET® instrument, the slope was 0.9650 and the correlation coefficient (r) was 0.9750 for Quantia IgE versus the UniCAP Total IgE Fluoroimmunoassay (K964152).

Within run precision assessed over multiple runs using Quantia Ferritin / Myoglobin / IgE Control on an Abbott AEROSET®, gave a CV of 6.4 % (at a mean of 47.3 IU/mL) and 0.7 % (at a mean of 406.5 IU/mL). A third control (control I + control II) gave a CV of 1.0 % (at a mean of 228.4 IU/mL).

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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 features a stylized depiction of an eagle with three overlapping, curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.

Public Health Service

AUG 1 6 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Biokit S.A. c/o Ms. Joan Guixer OA & RA Director Can Malé Llicà d'Amunt Barcelona, 08186 Spain

Re: K050493

Trade/Device Name: Quantia IgE Quantia Ferritin/Myoglobin/IgE Control Quantia IgE Standard Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A,G,M,D,E Immunological Test System Regulatory Class: Class II Product Code: DGC, JJX, JJS Dated: February 24, 2005 Received: March 1, 2005

Dear Ms. Guixer:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have leviewed your becalled is substantially equivalent (for the indications for referenced above and harve to legally marketed predicate devices marketed in interstate commerce use stated in the enorment date of the Medical Device Amendments, or to devices that provision way 26, 1970, the character with the provisions of the Federal Food, Drug, and Cosmetic have been roctablines an vire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mainter and as a set include requirements for annual registration, listing of devices, good controls provibitions or allabeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de vice to such additional controls. Existing major regulations affecting your device can be may of subject to sail adarate and Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act or that I Dry has made a acterinations 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); an the Aot of equirements) ; good manufacturing practice requirements as set forth in the quality

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Page 2

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.

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 vours,

Robert A. Becker

Robert L. Becker, Jr., M.D., & Director Division of Immunology and Hematology Devices 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): K050493

Device Name: Quantia IgE. .

Indications for Use:

Quantia IgE Standard is intended for use in establishing the calibration curve for the Quantia IgE reagents by turbidimetry. For in vitro diagnostic use.

Prescription Use X (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 Chan

Division Sign-Off

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) K0550493

Regulation Number and Section

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).