(31 days)
No
The document describes a drug calibrator, a liquid human serum matrix with added drugs, used for calibrating clinical chemistry analyzers. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the chemical composition and stability of the calibrator.
No
The device is a calibrator for in vitro diagnostic tests, specifically for gentamicin and tobramycin levels, not a device used for treatment or diagnosis of a disease.
No
This device is a calibrator, used to ensure the accuracy of other diagnostic tests for gentamicin and tobramycin. It does not directly diagnose a condition or disease in a patient.
No
The device description explicitly states it is a "liquid human serum matrix" with added substances, indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "for the calibration of gentamicin and tobramycin" when used with specific reagents on SYNCHRON Systems. Calibration materials are essential components of in vitro diagnostic testing to ensure accurate results.
- Device Description: It is described as a "liquid human serum matrix to which gentamicin and tobramycin are added," designed for use with clinical chemistry analyzers. This description aligns with the nature of a calibrator used in laboratory testing.
- Context: The entire document describes a product used in a laboratory setting to calibrate instruments for measuring specific substances (gentamicin and tobramycin) in patient samples. This is the core function of an in vitro diagnostic device component.
- Predicate Device: The predicate device is also a "SYNCHRON Systems DRUG CALIBRATOR 3," further indicating its classification as an IVD.
Therefore, based on the provided information, the SYNCHRON Systems DRUG CALIBRATOR 3 PLUS is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SYNCHRON® Systems DRUG CALIBRATOR 3 PLUS, when used in conjunction with SYNCHRON Gentamicin Reagent and Tobramycin Reagent, is intended for use on the SYNCHRON Systems and for the calibration of gentamicin and tobramycin.
Product codes
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Device Description
The SYNCHRON Systems DRUG CALIBRATOR 3 PLUS is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems. The SYNCHRON Systems DRUG CALIBRATOR 3 PLUS is for use in the calibration of SYNCHRON Systems Gentamicin and Tobramycin chemistries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence of the SYNCHRON Systems DRUG CALIBRATOR 3 PLUS to the SYNCHRON Systems DRUG CALIBRATOR 3 and is stable for gentamicin and tobramycin. The value assignment process for each analyte demonstrates the ability to recover weighed in analyte levels which can be correlated to a known standard via the anchor method.
Stability Testing Summary:
- Stress Temperature 25°C, Duration of Incubation 60 Days, Predicted Stability 30 Months, Beckman Stability Claim* 24 Months
- Stress Temperature 37°C, Duration of Incubation 21 Days, Predicted Stability 30 Months, Beckman Stability Claim* 24 Months
- Stress Temperature 45°C, Duration of Incubation 10 Days, Predicted Stability 30 Months, Beckman Stability Claim* 24 Months
- Expiration dating placed on the package based on date of manufacture
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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MAY - 8 1997
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അവലംബം
പുറത്തിനും
Summary of Safety & Effectiveness SYNCHRON ® Systems DRUG CALIBRATOR 3 PLUS
1.0 Submitted By:
Sheri Hall Product Submissions Manager Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 993-8961 FAX: (714) 961-4457
2.0 Date Submitted:
1 April 1997
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® Systems DRUG CALIBRATOR 3 PLUS
Classification Name 3.2
(21 CFR § 862.1150) Calibrator
4.0 Predicate Device(s):
. . .
| SYNCHRON Systems
CAL 5 Plus | Predicate | Predicate Company | Docket
Number |
|-----------------------------------------------|---------------------------------------|------------------------------|------------------|
| SYNCHRON Systems
DRUG CALIBRATOR 3
PLUS | SYNCHRON Systems
DRUG CALIBRATOR 3 | Beckman
Instruments, Inc. | K955644 |
1
Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems DRUG CALIBRATOR 3 PLUS Summary of Safety & Effectiveness
5.0 Description:
The SYNCHRON Systems DRUG CALIBRATOR 3 PLUS is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems. The SYNCHRON Systems DRUG CALIBRATOR 3 PLUS is for use in the calibration of SYNCHRON Systems Gentamicin and Tobramycin chemistries.
6.0 Intended Use:
The SYNCHRON® Systems DRUG CALIBRATOR 3 PLUS, when used in conjunction with SYNCHRON Gentamicin Reagent and Tobramycin Reagent, is intended for use on the SYNCHRON Systems and for the calibration of gentamicin and tobramycin.
7.0 Comparison to Predicate(s):
The SYNCHRON Systems DRUG CALIBRATOR 3 PLUS is a liquid human serum matrix to which gentamicin and tobramycin are added. The SYNCHRON Systems DRUG CALIBRATOR 3 (six level set) contained only centamicin. The SYNCHRON Systems DRUG CALIBRATOR 3 PLUS will contain both gentamicin and tobramycin into a single, six level, calibrator set. The SYNCHRON Systems DRUG CALIBRATOR 3 PLUS is intended to be used on Beckman's SYNCHRON Systems.
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence of the SYNCHRON Systems DRUG CALIBRATOR 3 PLUS to the SYNCHRON Systems DRUG CALIBRATOR 3 and is stable for gentamicin and tobramycin. The value assignment process for each analyte demonstrates the ability to recover weighed in analyte levels which can be correlated to a known standard via the anchor method.
| Stress
Temperature | Duration of
Incubation | Predicted
Stability | Beckman
Stability Claim* |
|-----------------------|---------------------------|------------------------|-----------------------------|
| 25°C | 60 Days | 30 Months | 24 Months |
| 37°C | 21 Days | 30 Months | 24 Months |
| 45°C | 10 Days | 30 Months | 24 Months |
SYNCHRON Systems DRUG CALIBRATOR 3 PLUS
Stability Testing Summary
- Expiration dating placed on the package based on date of manufacture
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 required 21 CFR 807.92.
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