(13 days)
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No
The description focuses on a calibration verification material for an immunoassay analyzer and does not mention any AI/ML components or functions.
No
This device is for quantitative verification of calibration curves for immunoassay analyzers, not for treating a disease or condition.
No.
The device is intended for the quantitative verification of the calibration curve of an immunoassay analyzer, meaning it checks the performance of another diagnostic device, rather than directly diagnosing a patient's condition.
No
The device description clearly states it is a "three level single analyte set of lyophilized, human based materials," indicating it is a physical reagent kit, 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 FT4 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers." This is a diagnostic purpose, specifically related to ensuring the accuracy of a diagnostic test (Elecsys FT4).
- Device Description: It describes a "three level single analyte set of lyophilized, human based materials" that are "assayed in triplicate and the results are compared to the target values." This is a typical description of a quality control or calibration verification material used in in vitro diagnostic testing.
- 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.
While it doesn't directly test a patient sample, it is a critical component used with an in vitro diagnostic test (the Elecsys FT4 assay) to ensure the reliability and accuracy of the results obtained from patient samples. Therefore, it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
Elecsys CalCheck FT4 is intended for use in the quantitative verification of the calibration curve established by the Elecsys FT4 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Elecsys CalCheck FT4 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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AUG 27 1996
510(k) Summary
Elecsys® CalCheck™ FT4
| 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 FT4 |
| | 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 FT4 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 FT4 is intended for use in the quantitative verification of
the calibration curve established by the Elecsys FT4 reagents and calibrators
on Elecsys 1010 or 2010 immunoassay analyzers. |
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510(k) Summary, Elecsys® CalCheck™ FT4, Continued
- Comparison to predicate device
The Boehringer Mannheim Elecsys CalCheck FT4 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 HCG Calibration Verification Test Set, K924862.
The intended use of both the Elecsys CalCheck FT4 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.