(69 days)
None
Not Found
No
The summary describes a standard in vitro diagnostic reagent kit for measuring pancreatic α-amylase, with no mention of AI or ML in the intended use, device description, or any other section.
No
Explanation: The device is an in vitro diagnostic reagent used to measure pancreatic α-amylase levels in samples, which aids in the diagnosis of pancreatic disorders. It is not used for treating or modifying a disease state.
Yes
The "Intended Use / Indications for Use" states that it is an "in vitro diagnostic reagent".
No
The device is described as an in vitro diagnostic reagent test kit, which is a physical product used in a laboratory setting, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"Randox Laboratories Limited Pancreatic α - Amylase (Ethylidene Blocked - pNPGyme Colorimetric Test) is an in vitro diagnostic reagent for the quantitative ermination of pancreatic α - amylase in serum and urine samples."
This statement clearly identifies the device as an in vitro diagnostic reagent intended for use outside of the body to diagnose or aid in the diagnosis of a condition (pancreatic disorders).
N/A
Intended Use / Indications for Use
Randox Laboratories Limited Pancreatic α - Amylase (Ethylidene Blocked - pNPGyme Colorimetric Test) is an in vitro diagnostic reagent for the quantitative ermination of pancreatic α - amylase in serum and urine samples. This test kit measures pancreatic isoamylase and therefore has greater clinical specificity for the diagnosis of creatic disorders when compared to total amylase assessment. This test kit must be d by suitable qualified laboratory personnel under appropriate laboratory conditions.
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
suitable qualified laboratory personnel under appropriate laboratory conditions.
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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. P. Armstrong Randox Laboratories Ltd. Ardmore, · Diamond Road Crumlin Co, Antrim United Kingdom, BT29 4QY
K971825 Re : Pancreatic α - amylase Requlatory Class: II Product Code: JFJ Dated: July 3, 1997 Received: July 11, 1997
Dear Dr. Armstrong:
JUL 2 4 1997
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 requlation (21 CFR Part 801 and 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, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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 | 1 of 1 |
|---|---|
| ------ | -------- |
(k) Number (if known) K971825
PANCREATIC a - AMYLASE ce Name __
ETHYLIDENE BLOCKED - pNPG- ENZYME COLORIMETRIC TEST
cations For Use :
Randox Laboratories Limited Pancreatic α - Amylase (Ethylidene Blocked - pNPGyme Colorimetric Test) is an in vitro diagnostic reagent for the quantitative ermination of pancreatic α - amylase in serum and urine samples. This test kit measures pancreatic isoamylase and therefore has greater clinical specificity for the diagnosis of creatic disorders when compared to total amylase assessment. This test kit must be d by suitable qualified laboratory personnel under appropriate laboratory conditions.
EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
scription Use r 21 CFR 801.109)
OR
Over-The-Counter Use (Optional format 1-2-96)
(Division Sign-Off
Division Clinet Lahjatory des Ca
510(k) Numb. 977825