(51 days)
Not Found
No
The summary describes a chemical reagent for quantitative determination of ammonia in plasma using standard laboratory analyzers, with no mention of AI or ML.
No
The device is a reagent for the quantitative determination of ammonia in plasma, which is used for diagnostic purposes, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" states that the device is "intended for the quantitative determination of ammonia concentration in plasma," which directly aligns with the definition of a diagnostic device (determining the presence or state of a disease or condition).
No
The device description clearly states it is a "reagent," which is a chemical substance used in a chemical reaction, not a software-only component. It is intended for use on specific hardware systems (SYNCHRON CX and LX Systems).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "intended for the quantitative determination of ammonia concentration in plasma". This indicates a test performed on a biological sample (plasma) outside of the body to provide information about a patient's health.
- Device Description: The description confirms it's a "reagent" used for "quantitative determination of ammonia in plasma". Reagents are key components of IVD tests.
- Performance Studies: The performance studies describe method comparison and imprecision experiments, which are standard evaluations for IVD devices to demonstrate their accuracy and reliability.
- Predicate Device: The mention of a "Predicate Device" (Ammonia reagent on the Dade aca clinical analyzer) is a strong indicator that this device is being compared to an existing IVD device for regulatory purposes.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SYNCHRQN® Systems Ammonia (AMM) Reagent, in conjunction with SYNCHRON® Systems Ammonia Calibrators, is intended for the quantitative determination of ammonia concentration in plasma on SYNCHRON® Systems.
Product codes
JIF
Device Description
The SYNCHRON System Ammonia Reagent is designed for optimal performance on the SYNCHRON CX and LX Systems. It is intended for use in the quantitative determination of ammonia in plasma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
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
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, and imprecision experiments.
Method Comparison Study Results SYNCHRON® Systems Digoxin (DIGN) Reagent:
SYNCHRON CX System: Sample Type = Plasma, Slope = 1.018, Intercept = -5.3 µmol/L, r = 0.9991, n = 82, Predicate Method = Dade aca
SYNCHRON LX System: Sample Type = Plasma, Slope = 1.003, Intercept = -2.2 µmol/L, r = 0.9986, n = 82, Predicate Method = Dade aca
Estimated Within-Run Imprecision:
CX System:
Level 1: Mean = 48 µmol/L, S.D. = 2.6 µmol/L, %C.V. = 4.2, N = 15
Level 2: Mean = 128 µmol/L, S.D. = 3.0 µmol/L, %C.V. = 2.3, N = 15
Level 3: Mean = 644 µmol/L, S.D. = 5.3 µmol/L, %C.V. = 0.8, N = 15
LX System:
Level 1: Mean = 48 µmol/L, S.D. = 2.3 µmol/L, %C.V. = 4.9, N = 15
Level 2: Mean = 128 µmol/L, S.D. = 2.8 µmol/L, %C.V. = 2.2, N = 15
Level 3: Mean = 644 µmol/L, S.D. = 4.9 µmol/L, %C.V. = 0.8, N = 15
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
JAN 29 1999
Image /page/0/Picture/1 description: The image contains a logo for Beckman Coulter. The logo consists of a stylized circular graphic to the left of the company name, which is written in bold, sans-serif font. The word "BECKMAN" is stacked on top of the word "COULTER". The letters are all capitalized. There is also the abbreviation "JAN" in the upper right corner of the image.
Summary of Safety & Effectiveness SYNCHRON® Systems Ammonia (AMM) Reagent
- 1.0 Submitted By:
Lucinda Stockert Staff Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4123
2.0 Date Submitted:
December 7, 1998
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® Systems Ammonia (AMM) Reagent
3.2 Classification Name
Ammonia (21CFR §862.1065)
4.0 Predicate Device(s):
| SYNCHRON Systems
Reagent | Predicate | Manufacturer | Docket
Number |
|---------------------------------------|-----------------------------------------------------------|-------------------|------------------|
| SYNCHRON®
Systems Ammonia
(AMM) | Ammonia reagent on the
Dade aca®* clinical
analyzer | Dade Behring, Inc | K770363 |
*Trademark of Dade Behring Inc. - formerly DuPont
5.0 Description:
The SYNCHRON System Ammonia Reagent is designed for optimal performance on the SYNCHRON CX and LX Systems. It is intended for use in the quantitative determination of ammonia in plasma.
Beckman Coulter, Inc. 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000
Telephone: (714) 993-5321 (714) 961-4165 Facsimile: Internet: www.beckmancoulter.com
1
Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® Systems Ammonia (AMM) Reagent Summary of Safety & Effectiveness
6.0 Intended Use:
The SYNCHRON® Systems Ammonia (AMM) Reagent, in conjunction with SYNCHRON® Systems Ammonia Calibrators, is intended for the quantitative determination of ammonia concentration in plasma on SYNCHRON® Systems.
7.0 Comparison to Predicate(s):
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| SIMILARITIES | ||
|---|---|---|
| SYNCHRON® | ||
| Systems | ||
| Ammonia | SYNCHRON assay uses GLDH | |
| enzymatic method for measuring | ||
| ammonia at 37°C. | Same as Dada aca Reagent | |
| GLDH source is beef liver | ||
| The reagent is ready to load onto the | ||
| instrument (requires no user preparation). | ||
| Reagent measures ammonia in human | ||
| plasma. | ||
| DIFFERENCES | ||
| Reagent components | All components of the SYNCHRON | |
| Ammonia reagent are liquid | ||
| Some components of the Dade aca | ||
| Ammonia reagent are in tablets and | ||
| others are liquid. | ||
| Sample Volume | SYNCHRON Ammonia assay | |
| requires 25 µL of sample. | ||
| aca assay requires 500 µL of | ||
| sample. | ||
| Type of measurement | SYNCHRON Ammonia is a timed | |
| endpoint assay. | ||
| Dade aca is a rate assay. |
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, and imprecision experiments.
| SYNCHRON
DIGN Reagent | Sample
Type | Slope | Intercept
(μmol/L) | r | n | Predicate
Method |
|--------------------------|----------------|-------|-----------------------|--------|----|---------------------|
| SYNCHRON
CX System | Plasma | 1.018 | -5.3 | 0.9991 | 82 | Dade aca |
| SYNCHRON LX
System | Plasma | 1.003 | -2.2 | 0.9986 | 82 | Dade aca |
Method Comparison Study Results SYNCHRON® Systems Digoxin (DIGN) Reagent
2
| SYNCHRON System | Sample | Mean (µmol/L) | S.D. (µmol/L) | %C.V. | N |
|---|---|---|---|---|---|
| CX | Level 1 | 48 | 2.6 | 4.2 | 15 |
| Level 2 | 128 | 3.0 | 2.3 | 15 | |
| Level 3 | 644 | 5.3 | 0.8 | 15 | |
| LX | Level 1 | 48 | 2.3 | 4.9 | 15 |
| Level 2 | 128 | 2.8 | 2.2 | 15 | |
| Level 3 | 644 | 4.9 | 0.8 | 15 |
Estimated Within-Run Imprecision
.
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three curved lines representing the head, body, and legs. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular pattern around the figure.
JAN 29 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Lucinda Stockert Staff Regulatory Specialist, Product Submissions BECKMAN COULTER, INC. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000
K984402 Re: Trade Name: SYNCHRON® Systems Ammonia (AMM) Reagent Regulatory Class: I Product Code: JIF December 7, 1998 Dated: December 9, 1998 Received:
Dear Ms. Stockert:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Butman
Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
page | of |
K984402 510(k) Number (if known):
Device Name: SYNCHRON® Systems
Ammonia (AMM) Reagent
Indications for Use:
The SYNCHRQN® Systems Ammonia (AMM) Reagent, in conjunction with SYNCHRON® Systems Ammonia Calibrators, is intended for the quantitative determination of ammonia concentration in plasma on SYNCHRON® Systems.
Clinical Significance:
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.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K984402
(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-Counter Use Optional Format 1-2-96
(