(9 days)
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No
The summary describes a calibration verification material for an immunoassay analyzer, which is a standard laboratory quality control product. There is no mention of AI or ML in the intended use, device description, or any other section.
No
The device is a calibration verification test set used in laboratory immunoassay analyzers to verify the accuracy of the calibration curve for CK-MB reagents. It does not directly provide therapy or interact with a patient for therapeutic purposes.
No
Explanation: This device is for verifying the calibration curve of an immunoassay analyzer, not for directly diagnosing medical conditions in patients. It ensures the accuracy of other diagnostic tests.
No
The device description clearly states it is a set of lyophilized, human-based materials, which are physical components, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quantitative verification of the calibration curve established by the Elecsys CK-MB reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers." This describes a product used in vitro (outside the body) to assess the performance of other diagnostic reagents and instruments.
- Device Description: It describes a "set of lyophilized, human based materials" that are "assayed" and "results are compared to the target values." This is consistent with the nature of materials used in laboratory testing to verify the accuracy of diagnostic procedures.
- Predicate Device: The predicate device listed, "Tosoh Medic AIA-Pack HCG Calibration Verification Test Set," is also a calibration verification product, which falls under the category of IVDs.
Therefore, the Elecsys CalCheck CK-MB fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Elecsys CalCheck CK-MB is intended for use in the quantitative verification of the calibration curve established by the Elecsys CK-MB reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.
Product codes
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Device Description
The Elecsys CalCheck CK-MB is a three level single analyte set of lyophilized, human based materials. After reconstitution they are assayed in triplicate and the results are compared to the target values.
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
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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
AUG 23 1996
510(k) Summary
Elecsys® CalCheck™ CK-MB
| 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) Submitter
name, address,
contact | Boehringer Mannheim Corporation
9115 Hague Rd.
Indianapolis, IN 46250
(317) 845-2000 |
| | Contact Person: John D. Stevens |
| | Date Prepared: August 12, 1996 |
| 2) Device name | Proprietary name: Elecsys CalCheck CK-MB |
| | Common name: Calibration Verification Material |
| | Classification name: Single (specified) analyte controls (assayed + unassayed) |
| 3) Predicate
device | We claim substantial equivalence to the Tosoh Medic AIA-Pack HCG
Calibration Verification Test Set, K924862. The intended use for both
products is to verify the calibration curve of automated immunoassay
analyzers |
| 4) Device
Description | The Elecsys CalCheck CK-MB is a three level single analyte set of
lyophilized, human based materials. After reconstitution they are assayed in
triplicate and the results are compared to the target values. |
| 5) Intended use | Elecsys CalCheck CK-MB is intended for use in the quantitative verification
of the calibration curve established by the Elecsys CK-MB reagents and
calibrators on Elecsys 1010 or 2010 immunoassay analyzers. |
1
510(k) Summary, Elecsys® CalCheck™ CK-MB, Continued
The Boehringer Mannheim Elecsys CalCheck CK-MB is substantially 6) Comparison to predicate equivalent to other products in commercial distribution intended for similar device use. Most notably it is substantially equivalent to the currently marketed Tosoh Medics AIA-Pack HCG Calibration Verification Test Set, K924862.
The intended use of both the Elecsys CalCheck CK-MB and the predicate device are the same in that they are intended to be used for the calibration verification for their labeled analytes on automated immunoassay analyzers.