(17 days)
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No
The summary describes a chemical calibrator for a clinical chemistry system, with no mention of software, algorithms, or any technology that would suggest AI/ML.
No.
The device is a calibrator for a clinical chemistry system, used to ensure the accuracy of the HCG method, not to directly treat or diagnose a disease or condition in a patient.
No
Explanation: The device is a calibrator for an HCG method, not a diagnostic device itself. Its purpose is to calibrate a diagnostic system, not to directly provide diagnostic information about a patient.
No
The device description explicitly states it is a "lyophilized horse serum-based product" and a "kit consisting of ten vials," indicating it is a physical, chemical-based product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's used to "calibrate the HCG method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module." This indicates it's used in vitro (outside the body) to ensure the accuracy of a diagnostic test (HCG method).
- Device Description: The description details the composition of the calibrator, which is a "lyophilized horse serum-based product" containing "human unne chorionic gonadotropin." This is a reagent used in a laboratory setting for testing.
- Predicate Device: The mention of a "Predicate Device" which is also an "aca® plus Human Chorionic Gonadotropin Calibrator" strongly suggests that this type of product is regulated as an IVD. Predicate devices are used in the regulatory process for new IVDs.
Therefore, based on the provided information, the HCG Calibrator fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
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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 unne chorionic gonadotropin. The kit consists of ten vials; two at each of five levels.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
aca® plus Human Chorionic Gonadotropin Calibrator
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1150 Calibrator.
(a)
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.)(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.
0
DADE
FEB 20 1997
DADE INTERNATIONA
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 unne 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 |
1
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. Ayers
Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 1/31/97