(36 days)
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No
The document describes a standard in vitro diagnostic assay for measuring ammonia levels, with no mention of AI or ML technologies in the device description or performance studies.
No.
This device is an in vitro diagnostic device used to measure ammonia levels, which aids in assessing hepatic function and diagnosing Reye's syndrome. It does not provide any therapeutic intervention.
Yes
The device is explicitly referred to as "an in vitro diagnostic device" in both the "Intended Use / Indications for Use" and "Device Description" sections. Furthermore, its intended use is to measure ammonia levels for "assessing hepatic function and diagnosis of Reye's syndrome," which are diagnostic purposes.
No
The device is an in vitro diagnostic device that measures ammonia levels in plasma, indicating it is a chemical assay requiring physical reagents and likely hardware for analysis, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Bayer ADVIA 1650 Ammonia method and calibrator is an in vitro diagnostic device intended to quantitatively measure ammonia levels in human plasma..."
The "Device Description" section also states: "The Bayer ADVIA 1650 Ammonia assay is an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma..."
These statements clearly identify the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bayer ADVIA 1650 Ammonia assay is an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA).
The Bayer ADVIA 1650 Ammonia method and calibrator is an in vitro diagnostic device intended to quantitatively measure ammonia levels in human plasma (heparin or EDTA). Such measurements are used in assessing hepatic function and diagnosis of Reye's syndrome.
Product codes (comma separated list FDA assigned to the subject device)
JIF, JIT
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)
Imprecision:
| ADVIA 1650 | Roche | ||
|---|---|---|---|
| Level (ug/dL) | Within-run CV(%) | Level (ug/dL) | Within-run CV(%) |
| 69.7 | 3.8 | 67.5 | 3.9 |
| 150.6 | 1.7 | 496.8 | 0.7 |
| 387.9 | 0.7 | 574.8 | 7.33 |
Correlation:
| Specimen Type | Comparison System (x) | N | Regression Equation | Syx | r | Sample Range ug/dL |
|---|---|---|---|---|---|---|
| Plasma | Roche (On Hitachi) | 94 | Y = 1.05x + 7.19 | 62.18 | 0.98 | 26 - 1174 |
Interfering Substances:
| METHOD | Sample Concentration | Interferent | Interferent Concentration (mg/dL) | Sample+Interferent Concentration | Recovery % |
|---|---|---|---|---|---|
| Ammonia | 179.28 | hemoglobin | 250 | 188.57 | 105.18% |
| 176.71 | bilirubin conj | 18.75 | 168.4 | 95.30% | |
| 168.25 | bilirubin unconj | 25 | 169.05 | 100.48% | |
| 214.24 | Intralipid | 62.5 | 195.08 | 91.06% | |
| 187.56 | TRIG Concentrate | 62.5 | 204.4 | 108.98% |
Analytical Range: Serum/Plasma(Lithium heparin): 25 to 1300 ug/dL
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.
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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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§ 862.1065 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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Ammonia method for ADVIA® 1650TM
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K 0 2 3 8 4/
1. Intended Use
The Bayer ADVIA 1650 Ammonia assay is an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA).
2. Predicate Device
| Product Name | Reagent Part # | Calibrator Part # |
|---|---|---|
| Roche Ammonia | 1877984 | 166570 |
3. Device / Method
| Product Name | Reagent Part # | Calibrator Part # |
|---|---|---|
| Bayer ADVIA® 1650™ Ammonia | B01-4822-01 | B03-4827-01 |
Imprecision
| ADVIA 1650 | Roche | ||
|---|---|---|---|
| Level | |||
| (ug/dL) | Within- | ||
| run | |||
| CV(%) | Level | ||
| (ug/dL) | Within- | ||
| run | |||
| CV(%) | |||
| 69.7 | 3.8 | 67.5 | 3.9 |
| 150.6 | 1.7 | 496.8 | 0.7 |
| 387.9 | 0.7 | 574.8 | 7.33 |
Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen
Type | Comparison
System (x) | N | Regression
Equation | Syx | r | Sample Range
µg/dL |
|------------------|--------------------------|----|------------------------|-------|------|-----------------------|
| Plasma | Roche
(On Hitachi) | 94 | $Y = 1.05x + 7.19$ | 62.18 | 0.98 | 26 - 1174 |
Interfering Substances
| METHOD | Sample
Concentration | Interferent | Interferent
Concentration
(mg/dL) | Sample+Interferent
Concentration | Recovery
% |
|---------|-------------------------|------------------|-----------------------------------------|-------------------------------------|---------------|
| Ammonia | 179.28 | hemoglobin | 250 | 188.57 | 105.18% |
| | 176.71 | bilirubin conj | 18.75 | 168.4 | 95.30% |
| | 168.25 | bilirubin unconj | 25 | 169.05 | 100.48% |
| | 214.24 | Intralipid | 62.5 | 195.08 | 91.06% |
| | 187.56 | TRIG Concentrate | 62.5 | 204.4 | 108.98% |
1
Analytical Range Serum/Plasma(Lithium heparin):
。
25 to 1300 ug/dL
Sa Si Parc, Andres Holle
11-/15-02
Date
Date
Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
DEC 24 2002
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
Mr. Andres Holle Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097
Re:
K023841 Trade/Device Name: Ammonia Assay and Calibrator for the ADVIA® 1650 Regulation Number: 21 CFR 862.1065 Regulation Name: Ammonia test system Regulatory Class: Class II Product Code: JIF; JIT Dated: November 15, 2002 Received: November 18, 2002
Dear Mr. Holle:
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. Iisting 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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small 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/dsma/dsmamain.html.
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page
K023841 510(k) Number:
Device Name: Ammonia Assay and Calibrator for the ADVIA® 1650™
Indications for Use:
The Bayer ADVIA 1650 Ammonia method and calibrator is an in vitro diagnostic device intended to quantitatively measure ammonia levels in human plasma (heparin or EDTA). Such measurements are used in assessing hepatic function and diagnosis of Reye's syndrome.
tean
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K023841
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-CounterUse
(Optional Format 1-2-96)