(32 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The intended use and device description (though not found) point towards a quantitative laboratory assay.
No
The device is for the quantitative determination of Amylase, which is a diagnostic measurement, not a therapy for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Amylase measurements are used primarily for the diagnostics and treatment of pancreatitis," indicating the device's role in diagnosis.
No
The provided text describes a device for the quantitative determination of Amylase in human serum and urine, which implies a laboratory or point-of-care testing device that would involve hardware for sample analysis. There is no mention of software as the primary or sole component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the quantitative determination of Amylase in human serum and urine." This indicates that the device is designed to analyze biological samples (serum and urine) outside of the body.
- Purpose: The purpose of the measurement is "for the diagnostics and treatment of pancreatitis." This clearly links the device's function to providing information for medical diagnosis and treatment decisions.
These are key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the quantitative determination of Amylase in human serum and urine. Amylase measurements are used primarily for the diagnostics and treatment of pancreatitis.
Product codes
JFJ
Device Description
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1070 Amylase test system.
(a)
Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).(b)
Classification. Class II.
0
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 stylized eagle with three stripes above it, all enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 0 2004
Mr. Jian Vaeches TECO Diagnostics 1268 North Lakeview Avenue Anaheim, CA 92807
K040920 Re: Trade/Device Name: Amylase Liquid Reagent Regulation Number: 21 CFR 862.1070 Regulation Name: Amylase test system Regulatory Class: Class II Product Code: JFJ Dated: March 26, 2004 Reccived: April 20, 2004
Dear Mr. Vaeches:
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).
1
Page 2
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 (301) 594-3084. 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,
Jean M. Cooper, US, DVM.
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
2
TECO DIAGNOSTICS
Image /page/2/Picture/2 description: The image shows a black hexagon with the letters "TC" in white inside. The letters are in a simple, sans-serif font and are centered within the hexagon. The overall design is clean and minimalist, suggesting a logo or emblem.
1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 693-7788 Toll Free: 1-800-222-9880 Fax: (714) 693-3838 www.tecodiag.com Email:tecodiag@tecodiag.com
ATTACHMENT 3
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):_K040920
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use: For the quantitative determination of Amylase in human serum and urine. Amylase measurements are used primarily for the diagnostics and treatment of pancreatitis.
Prescription Use Over-The-Counter Use AND/OR V (Part 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
Page I of 1 - 1
siok) K040920