HUMAN CHORIONIC GONADOTROPIN CALIBRATOR

K970396 · Dade Chemistry Systems, Inc. · JIW · Feb 20, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970396
• Device Name: HUMAN CHORIONIC GONADOTROPIN CALIBRATOR
• Applicant: Dade Chemistry Systems, Inc.
• Product Code: JIW · Clinical Chemistry
• Decision Date: Feb 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The HCG Calibrator is intended to be used to calibrate the HCG method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

Device Story

Lyophilized horse serum-based calibrator kit; contains human urine chorionic gonadotropin (levels 2-5); level 1 contains no detectable hCG. Used on Dimension® RxL clinical chemistry system with heterogeneous immunoassay module. Provides reference points for assay calibration; ensures accuracy of clinical chemistry measurements. Used in clinical laboratory settings by trained laboratory personnel.

Technological Characteristics

Lyophilized horse serum matrix; contains human urine chorionic gonadotropin; 5-level kit; 2.0 mL reconstituted volume per vial.

Indications for Use

Indicated for use as a calibrator for the HCG method on the Dimension® RxL clinical chemistry system to facilitate quantitative measurement of human chorionic gonadotropin.

Regulatory Classification

Identification

A 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. (See also § 862.2 in this part.)

Special Controls

*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.

Predicate Devices

• aca® plus Human Chorionic Gonadotropin Calibrator

Submission Summary (Full Text)

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DADE
K970396
FEB 20 1997
DADE INTERNATIONAL
Summary of Safety and Effectiveness Information
Chemistry Systems
P.O. Box 6101
Newark, DE 19714

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter's Name:
Rebecca S. Ayash
Dade International Inc.
Building 500, Mailbox 514
P.O. Box 6101
Newark, DE 19714-6101

Date of Preparation:
1/31/97

Name of Product:
Human Chorionic Gonadotropin Calibrator

FDA Classification Name:
Calibrator

Predicate Device:
aca® plus Human Chorionic Gonadotropin Calibrator

Device Description: The Human Chorionic Gonadotropin (HCG) Calibrator for the Dimension® RxL system is a lyophilized horse serum-based product. The Level 1 calibrator contains no detectable hCG. Levels 2 through 5 contain human urine chorionic gonadotropin. The kit consists of ten vials; two at each of five levels.

Intended Use: The HCG Calibrator is intended to be used to calibrate the HCG method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

Comparison to Predicate Device:

| | Dimension® RxL HCG Calibrator | aca® plus HCG Calibrator |
| --- | --- | --- |
| Intended Use | Calibrator | Calibrator |
| Analytes | Human Chorionic Gonadotropin | Human Chorionic Gonadotropin |
| Matrix | horse serum | horse serum |
| Form | lyophilized | lyophilized |
| Volume | 2.0 mL per vial, reconstituted | 3.0 mL per vial, reconstituted |
| Levels | 5 levels | 3 levels |

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Printed on recycled paper with 25% post-consumer fiber

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# Comments on Substantial

Equivalence: Both the HCG Calibrator for the Dimension® RxL system and the aca® plus HCG Calibrator are horse serum based products containing human urine chorionic gonadotropin as the analyte source and are intended to be used as calibrators for human chorionic gonadotropin assays.

Conclusion: The HCG Calibrator for the Dimension® RxL system is substantially equivalent to the aca® plus HCG Calibrator based on the comparison summarized above.

Rebecca S. Ayash
Regulatory Affairs and
Compliance Manager
Date: 1/31/97