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.

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. The SYNCHRON Systems DRUG CALIBRATOR 3 PLUS is a liquid human serum matrix to which gentamicin and tobramycin are added.

AI/ML Overview

This is a calibrator for a drug test, not an AI device. The requested information does not apply in this context.

Summary

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K971287

MAY - 8 1997

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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 SystemsCAL 5 Plus	Predicate	Predicate Company	DocketNumber
SYNCHRON SystemsDRUG CALIBRATOR 3PLUS	SYNCHRON SystemsDRUG CALIBRATOR 3	BeckmanInstruments, Inc.	K955644

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Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems DRUG CALIBRATOR 3 PLUS Summary of Safety & Effectiveness

5.0 Description:

6.0 Intended Use:

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.

StressTemperature	Duration ofIncubation	PredictedStability	BeckmanStability 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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Regulation Number and Section

§ 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.