(84 days)
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No
The summary describes a standard ELISA assay and an automated instrument for running the assay. There is no mention of AI or ML in the intended use, device description, or any other section.
No
Explanation: This device is for in vitro diagnostic use to aid in the diagnosis of Coeliac Disease by detecting antibodies in human serum, rather than directly treating or mitigating a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the results "can be used as an aid in the diagnosis of Coeliac Disease" and that the device is "For in vitro diagnostic use only."
No
The device description clearly states it is an "Enzyme linked immunosorbent assay method," which is a laboratory test involving physical reagents and procedures, not solely software. It also mentions validation for use with an "automated EIA instrument," indicating hardware involvement.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states "For in vitro diagnostic use only."
- Method: It uses an "Enzyme linked immunosorbent assay method," which is a common technique for in vitro testing of biological samples.
- Sample Type: It analyzes "human serum," which is a biological sample taken from a patient.
- Purpose: The results are used "as an aid in the diagnosis of Coeliac Disease," indicating a medical diagnostic purpose.
- Analyte: It determines the presence and level of "specific IgG autoantibodies to tissue transglutaminase (tTg)," which are biomarkers in the serum.
N/A
Intended Use / Indications for Use
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to tissue transglutaminase (tTg) in human serum.
Uses: The results of the anti-fTg assay can be used as an aid in the diagnosis of Coeliac Disease. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
In addition to the manual assay protocol, this device has been validated for use with the HYCOR HY.TEC automated EIA instrument. For in vitro diagnostic use only.
Product codes
MVM
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three wing-like shapes.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 7 - 2005
Hycor Biomedical Ltd. c/o Ms. Danielle M. Knight Pentlands Science Park Bush Loan Penicuik EH26 OPL United Kingdom
Re: K043433
K043433
Trade/Device Name: AUTOSTAT™ II Anti-Tissue Transglutaminase IgG ELISA
Trade/Device Name: AUTOSTATTM II Regulation Number: 21 CFR 866.5660 Regulation Name: 21 OF Resolution immunological test system Regulatory Class: Class II Product Code: MVM Dated: December 7, 2004 Received: December 15, 2004
Dear Ms. Knight:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premanted is substantially equivalent (for the indications for referenced above and nave actemined the are devices marketed in interstate commerce
use stated in the enclosure) to legally marketed predicants, or to devices that use stated in the enclosure) to tegally manited proadine and mondments, or to devices that pror to May 28, 1976, the enactinent date of the Federal Food. Of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the CPMA >> have been reclassified in accordance with the provisional application (PMA). You may,
Act (Act) that do not require approval of a premarket approval application (Act (The yo Act (Act) that do not require approval of a provisions of the Act . The general therefore, market the device, subject to the general registration, list in the destices, good controls provisions of the netide requiritions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in h If your device is classified (sec above) into enaler regulations affecting your device can be may be subject to such additions, 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 Please be advised that FDA s Issualice of a substance of a subcures with other requirement of the Act or that FDA has made a decemination mar your as router Federal agencies. You must comply with (21) CED Port 807) any Federal Statules and regulations administered by two registration and listing (21 CFR Parts of the availity all ine Act s requirements, including, but no rise requirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturing practice the since duat reading rea labeling (21 CFR Part 801), good manazati.net production the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product systems (QS) regulation (21-542 of the Act); 21 CFR 1000-1050.
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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 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) 276-3084. 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 J. Backerh.
Robert L. Becker, Jr., M.D., PhD Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE.
510(k) Number (if known): K043433
Device Name: AUTOSTAT™ II Anti-Tissue Transglutaminase IgG ELISA
Indications For Use:
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to tissue transglutaminase (tTg) in human serum.
Uses:
The results of the anti-fTg assay can be used as an aid in the diagnosis of Coeliac Disease. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
In addition to the manual assay protocol, this device has been validated for use with the HYCOR HY.TEC automated EIA instrument.
For in vitro diagnostic use only.
ﮮ
Prescription Use Yes No (Part 21 CFR 801 Subpart D) Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
Mana M Chan
Division Sign-Off
Office of In Vitro Diagnosti Device Evaluation and SCIES
510(k) K043453