(44 days)
Not Found
No
The summary describes a standard in vitro diagnostic test kit and does not mention any AI or ML components.
No
This device is an in vitro diagnostic test used for the quantitative determination of amylase, which aids in diagnosis and treatment, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic test" and "is used in the diagnosis and treatment of pancreatitis."
No
The device is an in vitro diagnostic test kit, which is a chemical reagent-based product used with laboratory hardware, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "IL Test™ Amylase is an in vitro diagnostic test for use with Instrumentation Laboratory's line of clinical chemistry systems in the quantitative determination of amylase in human serum, plasma or urine..."
The "Device Description" section also reiterates this: "IL Test™ Amylase is an in vitro diagnostic test for use with Instrumentation Laboratory's line of clinical chemistry systems in the quantitative determination of amylase in human serum, plasma or urine..."
These statements clearly identify the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
IL Test™ Amylase is an in vitro diagnostic test for use with Instrumentation Laboratory's line of clinical chemistry systems in the quantitative determination of amylase in human serum, plasma or urine by CNP-Maltotrioside methodology. Amylase is used in the diagnosis and treatment of Pancreatitis.
Product codes
JFJ
Device Description
IL Test™ Amylase is an in vitro diagnostic test for use with Instrumentation Laboratory's line of clinical chemistry systems in the quantitative determination of amylase in human serum, plasma or urine by CNP-Maltotrioside methodology.
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 47 serum samples, the correlation (r) of the new IL Test™ Amylase to the predicate IL Test™ Amylase was 1.000. In a separate study evaluating 71 urine samples, the correlation (r) of the new IL Test™ Amylase to the predicate IL Test™ Amylase was 0.999.
Within run precision for a serum sample accessed over multiple runs gave a CV of 1.6 % at a mean of 49 U/L and 1.0 % at a mean of 157 U/L. Within run precision for a urine sample accessed over multiple runs gave a CV of 1.5 % at a mean of 278 U/L and 1.6% at a mean of 302 U/L.
Key Metrics
Not Found
Predicate Device(s)
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
SECTION 3 IL Test™ Amylase - 510(k) SUMMARY (Summary of Safety and Effectiveness)
Submitted by:
Carol Marble Regulatory Affairs Engineer Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: (617) 861-4467 (617) 861-4464 Fax:
Contact Persons:
Carol Marble Phone: (617) 861-4467 DEC 17 1997
Alternate: Betty Lane Phone: (617) 861-4182
Summary Prepared:
October 31, 1997
Name of the device:
IL Test™ Amylase
Classification name(s):
| 862.1070 | Amylase test systems | Class II |
|---|---|---|
| 75CIJ | Saccharogenic, Amylase |
Identification of predicate device(s):
IL Test™ Amylase K932467 K943595 - Serum and Urine Claims Added
Description of the device/intended use(s):
IL Test™ Amylase is an in vitro diagnostic test for use with Instrumentation Laboratory's line of clinical chemistry systems in the quantitative determination of amylase in human serum, plasma or urine by CNP-Maltotrioside methodology. Amylase is used in the diagnosis and treatment of Pancreatitis.
Statement of how the Technological Characteristics of the Device compare to the Predicate device:
The new IL Test™ Amylase has the same intended use as the predicate II Test™ Amylase and is substantially equivalent in performance and safety and effectiveness.
Summary of Performance Data:
In a method comparison study evaluating 47 serum samples, the correlation (r) of the new IL Test™ Amylase to the predicate IL Test™ Amylase was 1.000. In a separate study evaluating 71 urine samples, the correlation (r) of the new IL Test™ Amylase to the predicate IL Test™ Amylase was 0.999.
Within run precision for a serum sample accessed over multiple runs gave a CV of 1.6 % at a mean of 49 U/L and 1.0 % at a mean of 157 U/L. Within run precision for a urine sample accessed over multiple runs gave a CV of 1.5 % at a mean of 278 U/L and 1.6% at a mean of 302 U/L.
Page 1 of 1 IL Test™ Amylase 510(k) Section 3
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Image /page/1/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 overlapping, curved lines representing its wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 17 1997
Carol Marble Regulatory Affairs Engineer Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173-3190
Re : K974125 IL Test™ Amylase Regulatory Class: II Product Code: JFJ October 31, 1997 Dated: November 3, 1997 Received:
Dear Ms. Marble:
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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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.
2
Page 2
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 regulation (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 Sitman
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
3
Indications for Use Statement
510(k) Number (if known): K974125
Device Name: IL Test™ Amylase
Indications for Use:
ଫ୍ରି
il. Test™ Amylase is an in vitro diagnostic test for use with Instrumentation Laboratory's line of clinical chemistry systems in the quantitative determination of amylase in human serum, plasma or urine by CNP-Maltotrioside methodology. Amylase is used in the diagnosis and treatment of pancreatitis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number |
| Prescription Use
| (Per 21 CFR 801.019) | OR Over-The-Counter Use |
|---|---|
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| Section 2 | IL Test™ Amylase 510(k) | Page 1 of 1 |
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