(13 days)
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No
The summary describes a calibration verification material for an immunoassay analyzer, which is a standard laboratory control product. There is no mention of AI or ML in the intended use, device description, or any other section.
No
The device is described as a "calibration verification test set" used to verify the calibration curve of immunoassay analyzers, rather than directly treating a disease or condition.
No
Explanation: This device is clearly labeled as a "CalCheck" and is intended for "quantitative verification of the calibration curve established by the Elecsys T 3 reagents and calibrators". It is used to check the calibration of other diagnostic devices, not to diagnose a condition itself.
No
The device description clearly states it is a set of lyophilized, human-based materials, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "quantitative verification of the calibration curve established by the Elecsys T 3 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers." This indicates it's used in vitro (outside the body) to assess the performance of other diagnostic reagents and instruments.
- Device Description: It describes the device as "lyophilized, human based materials" that are "assayed in triplicate." This further supports its use in a laboratory setting for testing purposes.
- Predicate Device: The presence of a predicate device (Tosoh Medic AIA-Pack HCG Calibration Verification Test Set) with a K number (K924862) strongly suggests that this device is also an IVD, as predicate devices are typically other legally marketed IVDs.
While the document doesn't explicitly state "In Vitro Diagnostic," the combination of the intended use, device description, and the presence of a predicate device used for a similar purpose (calibration verification) makes it clear that this device falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
Elecsys CalCheck T 3 is intended for use in the quantitative verification of the calibration curve established by the Elecsys T 3 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.
Product codes
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Device Description
The Elecsys CalCheck T 3 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
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AUG 27 1996
510(k) Summary
Elecsys® CalCheck™ T 3
| 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 T 3 |
| | 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 T 3 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 T 3 is intended for use in the quantitative verification of the
calibration curve established by the Elecsys T 3 reagents and calibrators on
Elecsys 1010 or 2010 immunoassay analyzers. |
1
510(k) Summary, Elecsys® CalCheck™ T 3, Continued
The Boehringer Mannheim Elecsys CalCheck T 3 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 T 3 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.