(207 days)
Not Found
No
The device description details a standard enzymatic assay for ammonia detection based on spectrophotometry. There is no mention of AI or ML in the intended use, device description, or the "Mentions AI, DNN, or ML" section. The performance studies described are typical for a clinical chemistry assay and do not suggest the use of AI/ML.
No
This device is an in vitro diagnostic assay used for quantitative determination of ammonia in human plasma, which aids in the diagnosis and treatment of certain liver disorders. It does not directly treat or prevent a disease, but rather provides information for diagnostic purposes.
Yes
The text explicitly states, "The Sentinel Ammonia Ultra Diagnostic Assay described in this 510(k) submission is composed by reagent, calibrator and controls... The Ammonia Ultra is an enzymatic in vitro diagnostic assay for the quantitative determination of ammonia in human plasma." It also mentions its use in the "diagnosis and treatment of severe liver disorders."
No
The device description clearly states it is composed of reagent, calibrator, and controls, which are physical components, not software. It describes an enzymatic in vitro diagnostic assay involving chemical reactions and absorbance measurements.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states the device is intended for the "in vitro quantitative determination of Ammonia (NH3) in human plasma." "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The description further clarifies that the device is an "enzymatic in vitro diagnostic assay."
- Professional Use: The device is intended for "professional use," which is typical for IVDs used in clinical laboratories.
- Components: The device is composed of reagents, calibrators, and controls, which are standard components of IVD kits used for laboratory testing.
- Purpose: The purpose is to measure a substance (Ammonia) in a biological sample (human plasma) to aid in the diagnosis and treatment of medical conditions.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ammonia Ultra is intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye's syndrome.
The Ammonia Controls are intended as a means of monitoring Sentinel Ammonia Ultra assay method.
Product codes (comma separated list FDA assigned to the subject device)
JIF, JJX
Device Description
The Sentinel Ammonia Ultra Diagnostic Assay described in this 510(k) submission is composed by reagent, calibrator and controls, packaged and distributed in different kits. The device is intended to be sold as an in-vitro test for professional use.
The Ammonia Ultra is an enzymatic in vitro diagnostic assay for the quantitative determination of ammonia in human plasma. Ammonia, in the presence of glutamate dehydrogenase (GLDH), combines with alpha-ketoglutarate and NADH to yield glutamate and NAD*. The decrease in absorbance due to the NADH oxidation, at 340 nm, is proportional to the ammonia concentration in the examined plasma. The reagent contains lactate dehydrogenase (LDH) in excess, to rapidly reduce endogenous pyruvate so that it does not interfere with the assay system. The actual concentration of ammonia is determined multiplying the rate of absorbace per the calibration factor obtained during the calibration with the ammonia standard of 500 µg/dL included in the kit.
To ensure a correct determination during quantification of ammonia samples, a quality control procedure is required. The Ammonia Controls are liquid controls at 3 levels, prepared in bovine albumin matrix, and are used to verify the performance of the Ammonia Ultra assay. The value and range assigned to each level is specific for each lot and has been determined in rigorously standardized condition by the calculation of the median obtained in multiple determinations using reagents and standard relative to the Ammonia Ultra.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human plasma
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use
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)
Performance evaluations included sensitivity, intra- and inter-assay imprecision, and method comparison.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
sensitivity, intra- and inter-assay imprecision
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.
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).
Not Found
§ 862.1065 Ammonia test system.
(a)
Identification. An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.(b)
Classification. Class I.
0
Image /page/0/Picture/0 description: The image shows the word "SENTINEL" in large, bold, black letters. Below the word "SENTINEL" is the word "DIAGNOSTICS" in smaller, thinner letters. The letters in "DIAGNOSTICS" are also black, but they are not as bold as the letters in "SENTINEL".
Kosm14
NOV 2 5 2005
510k Summary Sentinel Ammonia Ultra Diagnostic Assay
K Number:
| 1. Submitter's information: | Dr. Ugo De Luca
Managing Director
Sentinel CH Srl
Via Principe Eugenio
20155 Milan, Italy
Tel.: +39 02 345514 1
Fax: +39 02 345514 64
e-mail: sentinel@sentinel.it |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact person: | Mr. Davide Spada
Application Specialist
Sentinel CH Srl
Via Principe Eugenio
20155 Milan, Italy
Tel.: +39 02 345514 1
Fax: +39 02 345514 64
e-mail: spada@sentinel.it |
| 3. Date summary prepared: | 16 November 2005 |
Device name and classification 4.
The Sentinel Ammonia Ultra Diagnostic Assay described in this 510(k) consists of reagent and controls, packaged and distributed in two kits, but together making up the Ammonia assay. The device is intended to be sold as an in-vitro test for professional use.
Product name and classification information are provided in Table 4.1 below.
| Trade/Device Name | Regulation name | Classification
panel | Regulatory
class | Product
Code |
| ------------------- | ----------------- | ------------------------- | --------------------- | ----------------- |
|---|
| Trade/Device Name | Regulation name | Classification panel | Regulatory class | Product Code |
|---|---|---|---|---|
| Ammonia Ultra | Enzymatic Method, | |||
| Ammonia | Clinical | |||
| Chemistry | I | JIF | ||
| Ammonia Control | Single (Specified) | |||
| Analyte Controls | ||||
| (Assayed and | ||||
| Unassayed) | Clinical | |||
| Chemistry | I | JJX |
Page 62 of 74
1
Image /page/1/Picture/0 description: The image shows the logo for Sentinel Diagnostics. The logo is made up of two words, "SENTINEL" and "DIAGNOSTICS", stacked on top of each other. The word "SENTINEL" is in a larger, bolder font than the word "DIAGNOSTICS".
Device description 5.
The Sentinel Ammonia Ultra Diagnostic Assay described in this 510(k) submission is composed by reagent, calibrator and controls, packaged and distributed in different kits. The device is intended to be sold as an in-vitro test for professional use.
The Ammonia Ultra is an enzymatic in vitro diagnostic assay for the quantitative determination of ammonia in human plasma. Ammonia, in the presence of glutamate dehydrogenase (GLDH), combines with α-ketoglutarate and NADH to yield glutamate and NAD*. The decrease in absorbance due to the NADH oxidation, at 340 nm, is proportional to the ammonia concentration in the examined plasma. The reagent contains lactate dehydrogenase (LDH) in excess, to rapidly reduce endogenous pyruvate so that it does not interfere with the assay system. The actual concentration of ammonia is determined multiplying the rate of absorbace per the calibration factor obtained during the calibration with the ammonia standard of 500 µg/dL included in the kit.
To ensure a correct determination during quantification of ammonia samples, a quality control procedure is required. The Ammonia Controls are liquid controls at 3 levels, prepared in bovine albumin matrix, and are used to verify the performance of the Ammonia Ultra assay. The value and range assigned to each level is specific for each lot and has been determined in rigorously standardized condition by the calculation of the median obtained in multiple determinations using reagents and standard relative to the Ammonia Ultra.
Intended Use 6.
The Ammonia Ultra is intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma on automated system.
Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye's syndrome" CFR 862.1065
The Ammonia Controls are intended as a means of monitoring Sentinel Ammonia Ultra assay method.
Comparison with Predicate Devices 7.
Table 7.1 below provides a list of predicate devices for the Sentinel Ammonia Ultra Diagnostic Assay devices.
| # | Sentinel Trade Device Name | Predicate Device Name | Predicate Device Manufacturer | Predicate device (k) | FDA clearance date |
|---|---|---|---|---|---|
| 1 | Ammonia Ultra | Ammonia- | |||
| Incorporating | |||||
| Dynamic | |||||
| Stabilization | |||||
| Technology | Trace America, Inc | K974620 | 02 Jan. 1998 | ||
| 2 | Ammonia Controls | Quantimetrix | |||
| Ammonia Controls | Quantimetrix Corp. | K913346 | 25 Sep. 1991 |
Table 7.1 Predicate devices for Sentinel Ammonia Ultra Diagnostic Assay devices
2
Image /page/2/Picture/0 description: The image shows the logo for Sentinel Diagnostics. The word "SENTINEL" is in large, bold, black letters. Below that, in smaller letters, is the word "DIAGNOSTICS".
The Sentinel's Ammonia reagent and controls and the predicate devices are both used for the determination of ammonia. In addition, they use the same:
- Sample type: plasma .
- Technology: enzymatic .
- Detection method: NADH oxidation .
- Calibration: against aqueous standard .
However, Ammonia Ultra will be used with the Abbott ARCHITECT® c8000" analyzer, r over the Trace Ammonia labeling indicates that the product can be used with any automated clinical chemistry analyzer.
Performance Data 8.
Performance evaluations included sensitivity, intra- and inter-assay imprecision, and method comparison.
Conclusion 9.
The performance and safety data presented in this premarket notification support a finding of substantial equivalence between the Sentinel Ammonia Ultra Diagnostic Assay and the predicate devices specified in this submission.
Appendix E
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 5 2005
Mr. Davide Spada Application Specialist Sentinel CH. S.r.l. Via Principe Eugenio, 5 20155 Milan, Italy
K051114 Re:
Trade/Device Name: Sentinel Ammonia Ultra Regulation Number: 21 CFR 862.1065 Regulation Name: Ammonia test system Regulatory Class: Class I Product Code: JIF, JJX Dated: September 26, 2005 Received: November 8, 2005
Dear Mr. Spada:
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 bublish 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).
4
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your a substantial equivalence of your device to a legally premiuted 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) 276-0484. 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 I ou may of and Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto
Alberto Gutierrez, Ph.D.
Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): _ KOSIIIIY
Sentinel Ammonia Ultra Device Name:
Indications For Use:
The Ammonia Ultra is intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye's syndrome
Prescription Use X (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)
Carol Benam
Division Sign Off
Division Sian-C
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K051114
Page I of 7 -
6
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Ammonia Controls are intended as a means of monitoring Sentinel Ammonia Ultra assay method.
Prescription Use X (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)
Carol Buneen
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety
Page Lof 2 -
510(k) K051114