(137 days)
None
Not Found
No
The summary describes a reagent for a laboratory test, not a device that processes data or images using AI/ML. There are no mentions of AI, ML, or related concepts.
No
Explanation: This device is for the quantitative determination of a-Amylase, which is a diagnostic measurement, not a treatment.
Yes
The document states that the Amylase EPS Reagent is "used for the quantitative determination of a-Amylase... in human serum, plasma or urine" and that "a-Amylase is most frequently measured in the diagnosis of acute pancreatitis". This indicates its use in the diagnostic process.
No
The device is a reagent, which is a chemical substance used in a laboratory test, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the reagent is used for the "quantitative determination of a-Amylase... in human serum, plasma or urine". This is a classic definition of an in vitro diagnostic test, as it analyzes biological samples outside of the body to provide information about a person's health status.
- Purpose: The purpose of the test is for the "diagnosis of acute pancreatitis", which is a medical condition. IVDs are used to diagnose, monitor, or screen for diseases or conditions.
- Sample Type: The test is performed on "human serum, plasma or urine", which are biological specimens.
Therefore, based on the provided information, the Amylase EPS Reagent clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Amylase EPS Reagent is used for the quantitative determination of a-Amylase (1,4-α-D-glucan glucanohydrolase EC3.2.1.1) in human serum, plasma or urine on Beckman Coulter SYNCHRON CX ®/ LX ® Systems. a-Amylase is most frequently measured in the diagnosis of acute pancreatitis, when serum levels may be grossly elevated.
Product codes
JFJ
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
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 features a stylized depiction of an eagle or bird with three wing-like shapes extending upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Thermo Fisher Scientific c/o Ms. Melita Lambiris Quality Assurance Manager 189-199 Browns Road Noble Park, Victoria, 3174 Australia
MAY 2 2 2007
Re: K070064 Trade/Device Name: Amylase EPS Reagent
Regulation Number: 21 CFR 862.1070 Regulation Name: Amylase Test System. Regulatory Class: Class II Product Code: JFJ Dated: April 14, 2007 Received: April 23, 2007
Dear Ms. Lambiris:
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).
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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 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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., 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
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K070064
Amylase EPS Reagent Device Name:
Indications For Use:
The Amylase EPS Reagent is used for the quantitative (1,4-α-D-glucan determination of a-Amylase glucanohydrolase EC3.2.1.1) in human serum, plasma or urine on Beckman Coulter SYNCHRON CX ®/ LX ® Systems.
a-Amylase is most frequently measured in the diagnosis of acute pancreatitis, when serum levels may be grossly elevated.
X_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | |
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| Office of In Vitro Diagnostic Device Evaluation and Safety | |
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| K070064 |