(31 days)
Not Found
Not Found
No
The summary describes a quantitative determination of amylase using automated chemistry analyzers, which is a standard laboratory technique and does not mention any AI/ML components.
No
This device is for in vitro diagnostic (IVD) determination of amylase, used in diagnosing pancreatitis, not for therapy or treatment.
Yes
Explanation: The device is intended for the quantitative determination of amylase, and amylase measurements are explicitly stated to be used in the "diagnosis and treatment of pancreatitis." This directly indicates a diagnostic purpose.
No
The 510(k) summary describes an in vitro diagnostic device for measuring amylase in human serum, which inherently involves laboratory equipment and reagents, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Intended for the In Vitro, quantitative determination of amylase in human serum". "In Vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Sample Type: The device analyzes "human serum," which is a biological sample taken from the body.
- Purpose: The purpose is to "quantitatively determine amylase," which is a measurement of a substance in the biological sample.
- Clinical Application: The measurements are used in the "diagnosis and treatment of pancreatitis," indicating a medical purpose.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended for the In Vitro, quantitative determination of amylase in human serum on automated chemistry analyzers.
Amylase measurements are used in the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
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 and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and two curved lines representing its tail feathers.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. David Johnston Technical Director JAS Diagnostics, Inc. 7220 N.W. 58th Street Miami, FL 33166
FEB 2 8 2002
Re: K020282
Trade/Device Name: Amylase Reagent Regulation Number: 21 CFR 862.1070 Regulation Name: Amylase Test System Regulatory Class: Class II Product Code: JFJ Dated: January 7, 2002 Received: January 28, 2002
Dear Mr. Johnston:
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.
1
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (Joase contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page
510(k) Number (if known): __ Ko20282 Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use:
Intended for the In Vitro, quantitative determination of amylase in human serum on automated chemistry analyzers.
Amylase measurements are used in the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sean Cooper
(Division Sign-Off)
SSA
2/21/02
Division of Clinical Laboratory Devices
282
Prescription Use _v (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)