(109 days)
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No
The description details a standard clinical chemistry assay based on enzymatic reaction and spectrophotometric measurement. There is no mention of AI/ML algorithms for data analysis, interpretation, or decision support.
No.
This device is an in vitro diagnostic assay used for the quantitative determination of amylase in biological samples (serum, plasma, or urine) to aid in the diagnosis and treatment of pancreatitis. It does not directly provide therapy or treatment to a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis." This directly indicates that the device is used for diagnostic purposes.
No
The device is an in vitro diagnostic assay, which is a chemical reagent kit used with a specific hardware system (AEROSET System) to measure amylase levels in biological samples. It is not solely software.
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 Amylase assay is used for the quantitation of amylase in serum, plasma, or urine. These are biological samples taken from the body.
- Device Description: The "Device Description" further clarifies that it is an "in vitro diagnostic assay for the quantitative determination of amylase in serum, plasma, or urine." It describes a chemical reaction that occurs outside the body to measure a substance in a biological sample.
- Clinical Chemistry Assay: The description also identifies it as a "clinical chemistry assay," which is a common category of IVD.
- Performance Studies: The performance studies describe testing the assay's performance using biological samples (serum and urine) and comparing it to a predicate device, which is typical for IVD submissions.
The core function of the device is to analyze biological samples in vitro (outside the living organism) to provide information for medical diagnosis and treatment. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Amylase assay is used for the quantitation of amylase in serum, plasma, or urine on the AEROSET System. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
Product codes
JFJ
Device Description
Amylase is an in vitro diagnostic assay for the quantitative determination of amylase in serum, plasma, or urine. The Amylase assay is a clinical chemistry assay. The amylase in the sample hydrolyzes the 2-chloro-4-nitrophenyl-alpha-D-maltotrioside (CNPG3) to release 2-chloro-4-nitrophenol (CPNP) and form 2-chloro-4-nitrophenylalpha-D-maltoside (CNPG2), maltotriose (G3), and glucose (G). The rate of formation of the 2-chloro-4-nitrophenol is measured as an increase in the absorbance at 405 nm and is directly proportional to the activity of amylase present in the sample.
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)
Comparative performance studies were conducted using the AEROSET System. The Amylase assay method comparison yielded acceptable correlation with the Boehringer Mannheim o-Amylase/EPS assay on the Hitachi 717 Analyzer for the serum and urine applications. For serum applications, the correlation coefficient = 0.9990, slope = 1.237, and Y-intercept = - 1.232 U/L. For urine applications, the correlation coefficient = 0.9963, slope = 1.042, and Y-intercept = 2.102 U/L. Precision studies were conducted using the Amylase assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 is 1.0% and Level 2/Panel 102 is 1.6% for serum applications, and 1.3% for Level 1/Panel 201, and 1.1% for Level 2/Panel 202 for urine applications. The Amylase assay is linear up to 3010.3 U/L. The limit of quantitation (sensitivity) for the Amylase assay is 1.8 U/L. These data demonstrate that the performance of the Amylase assay is substantially equivalent to the performance of the Boehringer Mannheim alpha-Amylase/EPS assay on the Hitachi 717 Analyzer for the serum and urine applications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient = 0.9990 (serum), correlation coefficient = 0.9963 (urine), slope = 1.237 (serum), slope = 1.042 (urine), Y-intercept = - 1.232 U/L (serum), Y-intercept = 2.102 U/L (urine), total %CV for Level 1/Panel 101 is 1.0% (serum), total %CV for Level 2/Panel 102 is 1.6% (serum), total %CV for Level 1/Panel 201 is 1.3% (urine), total %CV for Level 2/Panel 202 is 1.1% (urine), linear up to 3010.3 U/L, limit of quantitation (sensitivity) is 1.8 U/L.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a caduceus, a symbol associated with medicine and healthcare. The text on the right is the name of the agency, with "FDA" in a bold, square font and the rest of the name in a more traditional font.
May 20, 2019
Abbott Laboratories Mark Littlefield Section Manager, Regulatory Affairs Dept. 09va Lc-2 1920 Hurd Drive Irving, TX 75038
Re: K981653
Trade/Device Name: Amy Regulation Number: 21 CFR 862.1070 Regulation Name: Amylase test system Regulatory Class: Class II Product Code: JFJ Dated: May 8, 1998 Received: May 11, 1998
Dear Mark Littlefield:
This letter corrects our substantially equivalent letter of August 28, 1998.
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/bmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
K981653 - Mark Littlefield
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kellie B. Kelm -S
Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: _ Amylase
Indications For Use:
The Amylase assay is used for the quantitation of amylase in serum, plasma, or urine on the AEROSET System. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas) .
AtH AWM
(Division Sign-off)
Division of Clinical Laboratory Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concyrrence of CDRH, Office of Device Evaluation (ODE) Prescription Use J OR Over-The-Counter Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
S
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1981653
510(k) Summary
Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Contact Person Mark Littlefield Section Manager MS 1-8 ADD Regulatory Affairs (972) 518-6062
Fax (972) 753-3367
| Date of Preparation of this Summary: | May 8, 1998 |
|---|---|
| Device Trade or Proprietary Name: | Amy |
| Device Common/Usual Name or Classification Name: | Amylase |
| Classification Number/Class: | 75JFJ/Class II |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: __
Test Description:
Amylase is an in vitro diagnostic assay for the quantitative determination of amylase in serum, plasma, or urine. The Amylase assay is a clinical chemistry assay. The amylase in the sample hydrolyzes the 2-chloro-4-nitrophenyl-α-D-maltotrioside (CNPG3) to release 2-chloro-4-nitrophenol (CPNP) and form 2-chloro-4-nitrophenylα-D-maltoside (CNPG2), maltotriose (G3), and glucose (G). The rate of formation of the 2-chloro-4-nitrophenol is measured as an increase in the absorbance at 405 nm and is directly proportional to the activity of amylase present in the sample.
Amylase 510(k) May 8, 1998 Amylaf Iwp
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Substantial Equivalence:
The Amylase assay is substantially equivalent to the Boehringer Mannheim® a - Amylase/EPS assay (K882225) on the Hitachi® Analyzer for serum, plasma, or urine applications.
These assays vield similar Performance Characteristics.
Similarities to Boehringer Mannheim.
- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of amylase in serum, . plasma, or urine.
- . Both assays yield similar clinical results.
Differences to Boehringer Mannheim:
- There is a minor difference between the assay range. .
Intended Use:
The amylase assay is used for the quantitation of amylase in human serum, plasma, or urine.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ System. The Amylase assay method comparison yielded acceptable correlation with the Boehringer Mannheim o-Amylase/EPS assay on the Hitachi 717 Analyzer for the serum and urine applications. For serum applications, the correlation coefficient = 0.9990, slope = 1.237, and Y-intercept = - 1.232 U/L. For urine applications, the correlation coefficient = 0.9963, slope = 1.042, and Y-intercept = 2.102 U/L. Precision studies were conducted using the Amylase assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 is 1.0% and Level 2/Panel 102 is 1.6% for serum applications, and 1.3% for Level 1/Panel 201, and 1.1% for
Amviase 510(k) May 8, 1998 Amylaf Iwp
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Level 2/Panel 202 for urine applications. The Amylase assay is linear up to 3010.3 U/L. The limit of quantititation (sensitivity) for the Amylase assay is 1.8 U/L. These data demonstrate that the performance of the Amylase assay is substantially equivalent to the performance of the Boehringer Mannheim or-Amylase/EPS assay on the Hitachi 717 Analyzer for the serum and urine applications.
Conclusion:
The Amylase assay is substantially equivalent to the Boehringer Mannheim α-Amylase/EPS assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.
Amylase 510(k) May 8, 1998 Amylaf lwp
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