(234 days)
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No
The summary describes reagents for chemical analysis, not a device that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or data analysis beyond basic measurement.
No
The device is described as reagents for measuring concentrations of substances in human samples, used as an aid in diagnosis. It is for "in vitro use in the clinical laboratory," indicating an analytic rather than a direct therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the obtained values from these reagents are useful "as an aid in the diagnosis" of various conditions (e.g., pancreatitis, liver disorders). This directly indicates a diagnostic purpose.
No
The device description is not provided, but the intended use clearly describes reagents for use with BioSystems BA analyzers. Reagents are chemical substances, not software.
Yes, based on the provided information, these devices are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use/Indications for Use: All the listed reagents are explicitly described as being for the "measurement of [substance] concentration in human serum, plasma or urine." They also state that the obtained values are "useful as an aid in the diagnosis" of specific conditions (pancreatitis, liver, hematological, and metabolic disorders). This clearly indicates they are intended for use on samples taken from the human body to provide information for diagnostic purposes.
- "Only for in vitro use in the clinical laboratory": This phrase is a strong indicator of an IVD. "In vitro" means "in glass" or "outside the body," and clinical laboratories are where diagnostic tests on biological samples are performed.
Therefore, the combination of measuring substances in human samples for diagnostic aid and the explicit "in vitro use" statement confirms that these devices are IVDs.
N/A
Intended Use / Indications for Use
alpha-AMYLASE DIRECT: Reagent for the measurement of alpha-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronic pancreatitis. This reagent institus of in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
alpha-AMYLASE EPS: Reagent for the measurement of alpha-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronic pancreatitis. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
alpha-AMYLASE PANCREATIC: Reagent for the measurement of pancreatic c-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronin pancreatitis. This reagentis for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
BILIRUBIN DIRECT: Reagent for the measurement of direct bilirubin concentration in human serum or plasma. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block. This reagent is for use in the BioSystems Blockers. Only for in vitro use in the clinical laboratory.
BILIRUBIN TOTAL: Reagent for the measurement of total bilirubin concentration in human serum or plasma. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, herrytological and metabolic disorders, including hepatitis and gall bladder block. This reagent is for nuse in the BioSystems Blockers. Only for in vitro use in the clinical laboratory.
Product codes (comma separated list FDA assigned to the subject device)
JFJ, CIG
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
Only for in vitro use in the clinical laboratory.
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): 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.
Not Found
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.
Not Found
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.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 2, 2019
BioSystems S.A. Noelia Gil Quality Assurance Specialist Costa Brava, 30 Barcelona, 08030 Spain
Re: K182474
Trade/Device Name: alpha-AMYLASE DIRECT alpha-AMYLASE EPS alpha-AMYLASE PANCREATIC BILIRUBIN DIRECT BILIRUBIN TOTAL Regulation Number: 21 CFR 862.1070 Regulation Name: Amylase test system Regulatory Class: Class II
Product Code: JFJ, CIG Dated: March 29, 2019 Received: April 1, 2019
Dear Noelia Gil:
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/pmn.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.
1
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 post marketing 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,
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182474
Device Name
alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN (DIRECT), BILIRUBIN (TOTAL)
Indications for Use (Describe)
alpha-AMYLASE DIRECT: Reagent for the measurement of alpha-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronic pancreatitis. This reagent institus of in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
alpha-AMYLASE EPS: Reagent for the measurement of alpha-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronic pancreatitis. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
alpha-AMYLASE PANCREATIC: Reagent for the measurement of pancreatic c-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronin pancreatitis. This reagentis for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
BILIRUBIN DIRECT: Reagent for the measurement of direct bilirubin concentration in human serum or plasma. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block. This reagent is for use in the BioSystems Blockers. Only for in vitro use in the clinical laboratory.
BILIRUBIN TOTAL: Reagent for the measurement of total bilirubin concentration in human serum or plasma. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, herrytological and metabolic disorders, including hepatitis and gall bladder block. This reagent is for nuse in the BioSystems Blockers. Only for in vitro use in the clinical laboratory.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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