(13 days)
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 intended for the quantitative verification of a calibration curve for Elecsys FT3 reagents and calibrators on immunoassay analyzers, rather than for treating a disease or condition.
No
The device is described as a "CalCheck" and is used to verify the calibration curve of other reagents and calibrators, not to diagnose a disease or condition in a patient.
No
The device description explicitly 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 FT 3 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers." This means it's 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 assays.
- 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, based on the provided information, the Elecsys CalCheck FT 3 is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Elecsys CalCheck FT 3 is intended for use in the quantitative verification of the calibration curve established by the Elecsys FT 3 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.
Product codes
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Device Description
The Elecsys CalCheck FT 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Andrews of Children
AJS 2 7 1995
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510(k) Summary
Elecsys® CalCheck™ FT 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 FT 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 FT 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 FT 3 is intended for use in the quantitative verification of
the calibration curve established by the Elecsys FT 3 reagents and calibrators
on Elecsys 1010 or 2010 immunoassay analyzers. |
r
1
510(k) Summary, Elecsys® CalCheck™ FT 3, Continued
The Boehringer Mannheim Elecsys CalCheck FT 3 is substantially equivalent 6) Comparison to other products in commercial distribution intended for similar use. Most to predicate 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 FT 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.