(26 days)
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No
The summary describes a calibration verification test for an assay, focusing on chemical composition and quality control, with no mention of AI or ML.
No
This device is a calibration verification product used to verify the calibration of an assay, not for treating or diagnosing a medical condition.
No
The device is used to verify calibration of an assay, not to diagnose a condition or disease in a patient. It is a quality control tool for an diagnostic assay.
No
The device description clearly states it is manufactured using human serum albumin and human Prolactin, indicating it is a physical reagent, not software.
Based on the provided information, the Boehringer Mannheim Elecsys® CalCheck™ Prolactin is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's used to "verify the calibration assignment for the Boehringer Mannheim Elecsys Prolactin assay." This indicates it's used in vitro (outside the body) to assess the performance of a diagnostic test (the Prolactin assay).
- Device Description: It's manufactured using human serum albumin and human Prolactin, and the analyte is spiked into a matrix. This describes a reagent or control material used in laboratory testing.
- Predicate Device: The mention of a predicate device (K924863 Tosoh Medics AIA-Pack FSH Calibration Verification Test) which is also a calibration verification test, further supports its classification as an IVD. Calibration verification materials are a common type of IVD used to ensure the accuracy of diagnostic instruments and assays.
While the document doesn't explicitly state "IVD," the intended use and nature of the device strongly align with the definition of an In Vitro Diagnostic product.
N/A
Intended Use / Indications for Use
The Boehringer Mannheim Elecsys® CalCheck™ Prolactin is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Prolactin assay.
Product codes
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Device Description
The Boehringer Mannheim Elecsys CalCheck Prolactin is manufactured using human serum albumin and human Prolactin. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled.
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 Elecsys® CalCheck™ Prolactin was evaluated for value assignment and stability.
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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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
K970147 FEB 10 1997
BOEHRINGER Summary
MANNHEIM
CORPORATION
Introduction According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence.
| 1. | Boehringer Mannheim Corporation |
|---|---|
| Submitter | 2400 Bisso Lane |
| name, | |
| address, | |
| contact | Concord, CA 94524-4117 |
| (510) 674-0690 extension 8413 | |
| Fax number: (510) 674-0690, x8413 |
Contact Person: Yvette Lloyd
Date Prepared: January 13, 1997
Proprietary name: Elecsys CalCheck Prolactin Device Name
Common name: Calibration Verification Material
Classification name: Single (specified) analyte controls (assayed + unassayed)
The Boehringer Mannheim Elecsys CalCheck Prolactin is substantially Predicate equivalent to the currently marketed Tosoh Medics AIA-Pack FSH device Calibration Verification Test. (K924863)
-
Device Description
The Boehringer Mannheim Elecsys CalCheck Prolactin is manufactured using human serum albumin and human Prolactin. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled.
Continued on next page
1
BOEHRINGER)
MANNHEIM
CORPORATION Summary, Continued
| 5.
| Intended use | The Boehringer Mannheim Elecsys® CalCheck™ Prolactin is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Prolactin assay. |
|---|---|
| 6. | |
| Comparison | |
| to predicate | |
| device | The Boehringer Mannheim Elecsys® CalCheck™ Prolactin is substantially equivalent to other products in commercial distribution intended for similar use. |
| Most notably, it is substantially equivalent to the currently marketed Tosoh Medics AIA-Pack FSH Calibration Verification Test. (K924863) | |
| Both products are intended to be used for the verification of calibration for analytes on automated immunoassay analyzers. | |
| 7. Performance | |
| Characteristics | The Elecsys® CalCheck™ Prolactin was evaluated for value assignment and stability. |
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