(13 days)
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No
The summary describes a calibration verification material for an immunoassay analyzer, which is a standard laboratory control material and does not mention any AI or ML components.
No
The device is described as "intended for use in the quantitative verification of the calibration curve established by the Elecsys T4 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers." This indicates it's a calibration verification material for diagnostic instruments, not a device used for treating disease or maintaining health.
No
Explanation: The device is intended for the quantitative verification of the calibration curve for Elecsys T4 reagents and calibrators on immunoassay analyzers, meaning it is used to check the accuracy of other diagnostic tools, not to diagnose a patient directly.
No
The device description explicitly 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 T4 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers." This involves testing a sample (the CalCheck material) in vitro (outside the body) to assess the performance of a diagnostic test (the Elecsys T4 assay).
- Device Description: It describes a "three level single analyte set of lyophilized, human based materials" that are "assayed in triplicate." This is a typical description of a quality control or calibration verification material used in laboratory testing.
- Predicate Device: The predicate device listed (Tosoh Medic AIA-Pack HCG Calibration Verification Test Set) is also a calibration verification material, which falls under the category of IVDs.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use and device description clearly align with the definition of an IVD, specifically a quality control or calibration verification product used in laboratory settings to ensure the accuracy of diagnostic tests.
N/A
Intended Use / Indications for Use
Elecsys CalCheck T4 is intended for use in the quantitative verification of the calibration curve established by the Elecsys T4 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers
Product codes
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Device Description
The Elecsys CalCheck T4 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
K96 3178
.
AUG 27 1996
... ...
510(k) Summary
Elecsys® CalCheck™ T4
| 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 T4
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 T4 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 T4 is intended for use in the quantitative verification of the calibration curve established by the Elecsys T4 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers |
1
510(k) Summary, Elecsys® CalCheck™ T4, Continued
The Boehringer Mannheim Elecsys CalCheck T4 is substantially equivalent 6) Comparison to predicate to other products in commercial distribution intended for similar use. Most device 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 T4 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.