(27 days)
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No
The summary describes a calibration verification material for an immunoassay analyzer and does not mention any AI or ML components.
No
This device is a calibration verification test set, used to confirm the accuracy of an immunoassay analyzer, not to treat or diagnose a disease.
No
This device is for quantitative verification of a calibration curve for Elecsys T Uptake reagents and calibrators. It is used to verify the performance of other diagnostic devices, not to diagnose a patient directly. Its function is quality control for diagnostic equipment.
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 clearly states it's for "quantitative verification of the calibration curve established by the Elecsys T Uptake reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers." This process is performed in vitro (outside the body) on samples (likely patient samples, although not explicitly stated for the CalCheck itself, it's used in conjunction with reagents and calibrators for patient testing).
- Device Description: It describes a "three level single analyte set of lyophilized, human based materials" that are "assayed." This aligns with the nature of materials used in in vitro diagnostic testing to ensure the accuracy of the testing system.
- Predicate Device: The mention of a predicate device (K924862, Tosoh Medic AIA-Pack HCG Calibration Verification Test Set) which is also a calibration verification test set, further supports its classification as an IVD. Calibration verification is a standard practice in IVD testing to ensure the accuracy and reliability of the results.
While the document doesn't explicitly state it's an IVD, the intended use and device description strongly indicate its role in the in vitro diagnostic process of verifying the calibration of an immunoassay analyzer used for patient testing.
N/A
Intended Use / Indications for Use
Elecsys CalCheck T Uptake is intended for use in the quantitative verification of the calibration curve established by the Elecsys T Uptake reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.
Product codes
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Device Description
The Elecsys CalCheck T Uptake 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.
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Image /page/0/Picture/0 description: The image shows the date SEP 10 1996. The letters SEP are in all caps and are followed by the number 10. The number 1996 is written after the number 10.
K9 63181
510(k) Summary
Elecsys® CalCheck™ T Uptake
| 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 Uptake |
| | 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 Uptake 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 Uptake is intended for use in the quantitative verification
of the calibration curve established by the Elecsys T Uptake reagents and
calibrators on Elecsys 1010 or 2010 immunoassay analyzers. |
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Image /page/1/Picture/0 description: The image shows a series of bold, black numbers and letters against a white background. The characters appear to be 'K963181'. The font is stylized and somewhat distorted, giving the impression of a handwritten or calligraphic style.
510(k) Summary, Elecsys® CalCheck™ T Uptake, Continued
The Boehringer Mannheim Elecsys CalCheck T Uptake 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 T Uptake 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.