(84 days)
Not Found
No
The summary describes a standard clinical chemistry reagent and analyzer system for quantitative determination of transferrin. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The performance studies focus on traditional analytical chemistry metrics like method comparison, stability, and imprecision.
No
This device is a reagent for quantitative determination, used to aid in diagnosis, not to provide therapy.
Yes
The device is intended for the "quantitative determination of human transferrin in serum or plasma," which "aids in the diagnosis of malnutrition, acute inflammation, infection, assessment of renal function and red blood cell disorders, such as iron deficiency anemia." This clearly indicates a diagnostic purpose.
No
The device is a reagent intended for use with a clinical chemistry analyzer, which is a hardware system. The summary describes performance studies related to the reagent's chemical properties and its interaction with the analyzer, not software functionality.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of human transferrin in serum or plasma." This involves testing biological samples in vitro (outside the body).
- Purpose: The measurement of transferrin "aids in the diagnosis of malnutrition, acute inflammation, infection, assessment of renal function and red blood cell disorders, such as iron deficiency anemia." This clearly indicates a diagnostic purpose.
- Device Description: It's a "Reagent" used in conjunction with a "Calibrator" on "clinical chemistry analyzers." Reagents and calibrators are essential components of IVD test systems.
- Performance Studies: The performance studies describe method comparison, stability, and imprecision experiments, which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device" with a K number (K780913) indicates that this device is being compared to a previously cleared device, a common process for IVDs seeking regulatory clearance.
All these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SYNCHRON LX Systems Transferrin (TRFN) Reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human transferrin in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.
The measurement of transferrin in serum or other body fluids aids in the diagnosis of malnutrition, acute inflammation, infection, assessment of renal function and red blood cell disorders, such as iron deficiency anemia.
Product codes
DDG
Device Description
The SYNCHRON LX Systems Transferrin (TRFN) Reagent in conjunction with SYNCHRON LX Calibrator 1, is intended for use on Beckman's SYNCHRON LX™20 Clinical Systems.
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
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, stability, and imprecision experiments that relate results obtained from Beckman's Immunochemistry System TRFN Transferrin (on ARRAY) Reagent to the SYNCHRON LX Transferrin (TRFN) Reagent.
Method Comparison Study Results: SYNCHRON LX Transferrin (TRFN) Reagent vs. Beckman TRFN Transferrin Reagent (on ARRAY)
Reagent: The SYNCHRON LX Transferrin (TRFN) Reagent
Slope: 1.041
Intercept (mg/dL): -20.7
r: 0.9844
n: 80
Predicate Method: Beckman's TRFN Transferrin Reagent on the ARRAY® Systems
Stability Study Results:
Reagent: SYNCHRON LX Transferrin (TRFN) Reagent
Product Claim: 24 month shelf-life, 14 day calibration stability, 60 days on-board stability
Estimated Within-Run Imprecision:
Sample: SYNCHRON LX Transferrin (TRFN) Reagent
Level 1: Mean (mg/dL) 135.7, S.D. (mg/dL) 2.00, %C.V. 1.47, N 80
Level 2: Mean (mg/dL) 218.6, S.D. (mg/dL) 2.95, %C.V. 1.35, N 80
Level 3: Mean (mg/dL) 303.5, S.D. (mg/dL) 4.08, %C.V. 1.34, N 80
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5880 Transferrin immunological test system.
(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).
0
AUG 20 1997
Summary of Safety & Effectiveness SYNCHRON LX™ Systems Transferrin (TRFN) Reagent
1.0 Submitted By:
Lucinda Stockert Senior Regulatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4457
2.0 Date Submitted:
21 May 1997
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON LX™ Systems Transferrin (TRFN) Reagent
3.2 Classification Names
Transferrin immunological test system (21 CFR 866.5880)
4.0 Predicate Device(s):
| SYNCHRON LX
Reagents | Predicate | Predicate
Company | Docket
Number |
|-------------------------------|------------------------------------------|------------------------------|------------------|
| Transferrin (TRFN)
Reagent | Beckman
Transferrin
(TRFN) Reagent | Beckman
Instruments, Inc. | K780913 |
5.0 Description:
The SYNCHRON LX Systems Transferrin (TRFN) Reagent in conjunction with SYNCHRON LX Calibrator 1, is intended for use on Beckman's SYNCHRON LX™20 Clinical Systems.
1
Beckman Instruments, Inc., Section 510(K) Notification SYNCHRON LX™ Systems Transferrin (TRFN) Reagent Summary of Safety & Effectiveness
6.0 Intended Use:
The SYNCHRON LX Systems Transferrin (TRFN) Reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human transferin in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.
7.0 Comparison to Predicate(s):
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
Reagent | Aspect/Characteristic | Comments |
---|---|---|
SIMILARITIES | ||
SYNCHRON LX Systems | ||
(TRFN) Reagent | Intended use | Same as the ARRAY System |
TRFN reagent quantitative | ||
determination of human transferrin | ||
Chemical reaction | Same principle as the ARRAY | |
System TRFN reagent; formation | ||
of antigen-antibody complexes | ||
Antibody | Same source, antibody, | |
processing, and buffer as the | ||
ARRAY System TRFN reagent | ||
Calibration | Same as the ARRAY System | |
TRFN reagent; single point update | ||
of manufacturer determined | ||
calibration curve |
2
| Reagent | Aspect
/Characteristic | Comments |
|------------------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DIFFERENCES | | |
| SYNCHRON LX
Systems (TRFN)
Reagent | Methodology | The SYNCHRON LX reads turbidimetrically and the
ARRAY System reads nephelometrically |
| | Measurement method | The SYNCHRON LX runs the reaction at 37°C and
reads an endpoint at 340 nm, where the ARRAY
System runs at 26.5°C and reads the rate of increase
in light scatter at 670 nm |
| | Range expansion | The SYNCHRON LX TRFN reagent measures
transferrin concentrations at the initial range of 75 -
800 mg/dL; while the ARRAY TRFN reagent
measures transferrin concentrations at the initial range
of 75-800 mg/dL and expanded range of 12.5 - 4,500
mg/dL |
| | Type of specimen | The SYNCHRON LX TRFN reagent measures
transferrin concentrations in serum or plasma
samples; while the ARRAY Systems TRFN reagent
measures transferrin concentrations in serum (plasma
samples are not recommended) or urine samples. |
| | Antigen excess
checking | The SYNCHRON LX TRFN reagent was designed so
that high antigen concentrations will not report in
range; the ARRAY System adds extra antibody to
observe for additional activity |
| | Packaging | The SYNCHRON LX TRFN reagent is packaged in
polystyrene cartridges; the ARRAY System TRFN
reagent is packaged in glass bottles |
3
Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON LX™ Systems Transferin (TRFN) Reagent Summary of Safety & Effectiveness
Summary of Performance Data: 8.0
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, stability, and imprecision experiments that relate results obtained from Beckman's Immunochemistry System TRFN Transferrin (on ARRAY) Reagent to the SYNCHRON LX Transferrin (TRFN) Reagent.
Method Comparison Study Results SYNCHRON LX Transferrin (TRFN) Reagent vs. Beckman TRFN Transferrin Reagent (on ARRAY)
| Reagent
(Analyte) | Slope | Intercept
(mg/dL) | r | n | Predicate Method |
|--------------------------------------------------|-------|----------------------|--------|----|----------------------------------------------------------------|
| The SYNCHRON LX
Transferrin (TRFN)
Reagent | 1.041 | -20.7 | 0.9844 | 80 | Beckman's TRFN
Transferrin Reagent on the
ARRAY® Systems |
Stability Study Results
Reagent | Product Claim |
---|---|
SYNCHRON LX Transferrin (TRFN) | |
Reagent | 24 month shelf-life |
14 day calibration stability | |
60 days on-board stability |
Estimated Within-Run Imprecision
| Sample | Mean
(mg/dL) | S.D.
(mg/dL) | %C.V. | N |
|----------------------------------------|-----------------|-----------------|-------|----|
| SYNCHRON LX Transferrin (TRFN) Reagent | | | | |
| Level 1 | 135.7 | 2.00 | 1.47 | 80 |
| Level 2 | 218.6 | 2.95 | 1.35 | 80 |
| Level 3 | 303.5 | 4.08 | 1.34 | 80 |
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.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lucinda Stockert Senior Requlatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Boulevard, W-337 Brea, California 92822-8000
AUG 20 1997
K971958/S1 Re: Trade Name: SYNCHRON LX™ Systems Transferrin (TRFN) Reagent Regulatory Class: II Product Code: DDG Dated: July 31, 1997 Received: August 5, 1997
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 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, Druq, 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 GMF regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Piease 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 Regulations.
5
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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
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
6
page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
SYNCHRON LX™ Systems Transferrin (TRFN) Reagent Device Name:
Indications for Use: .........................................................................................................................................................
The SYNCHRON LX Systems Transferrin (TRFN) Reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human transferrin in serum or plasma. This assav is designed for use with clinical chemistry analyzers from Beckman instruments, such as the SYNCHRON LX20 Clinical System.
The measurement of transferrin in serum or other body fluids aids in the diagnosis of malnutrition, acute inflammation, infection, assessment of renal function and red blood cell disorders, such as iron deficiency anemia.
21 CFR 866.5880 Transferrin immunological test system
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Division of Clinical Laboratory Devices
510(k) Number
| Prescription Use
(per 21 CFR 801.109) | OR | Over-the-Counter Use
Optional Format 1-2-96 |
------------------------------------------ | ---- | ------------------------------------------------ |
---|