(169 days)
No
The description focuses on a laboratory assay and its associated controls and standards, with no mention of AI or ML technologies.
No
The device is an in vitro diagnostic assay used for determining the concentration of Immunoglobulin E, which aids in the diagnosis of IgE-mediated allergies, but it does not provide therapy or treatment.
Yes
The intended use states that "Measurement of IgE is useful in the clinical diagnosis of IgE-mediated allergies". This indicates the device aids in diagnosis.
No
The device description clearly states it is an "immunoturbidimetric assay" and includes "reagents" and "standards," which are physical components, not software. It also mentions use on the "AEROSET System," which is a hardware analyzer.
Based on the provided text, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The text explicitly states "For in vitro diagnostic use" multiple times for the Quantia Ferritin / Myoglobin / IgE control and the Quantia IgE Standard.
- Intended Use: The intended use clearly describes the device as an "in vitro quantitative determination" of IgE in human serum or plasma. This means the test is performed outside of the body using biological samples.
- Clinical Diagnosis: The intended use also states that the measurement of IgE is "useful in the clinical diagnosis of IgE-mediated allergies," indicating its use in a clinical setting for diagnostic purposes.
- Control and Standard: The inclusion of controls and standards, explicitly labeled for "in vitro diagnostic use," further confirms the device's intended application in a diagnostic laboratory setting.
Therefore, the Quantia IgE assay, along with its associated control and standard, is intended for use in performing diagnostic tests on biological samples outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Quantia IgE 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 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.
Product codes
DGC, JJX, JJS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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).
Key Metrics
Not Found
Predicate Device(s)
K964152 UniCAP Total IgE Fluoroimmunoassay (Pharmacia)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 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.
1
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).
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 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
3
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
4
Indications for Use Statement
510(k) Number (if known): K050493
Device Name: Quantia IgE. .
Indications for Use:
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.
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