(10 days)
No
The summary describes a calibration verification material for an immunoassay analyzer, which is a standard laboratory quality 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 quantitative verification of calibration curve for immunoassay analyzers, which is a diagnostic function, not a therapeutic one.
No.
The device is used for quality control and calibration verification of immunoassay analyzers, rather than for diagnosing diseases in patients. It verifies the performance of other diagnostic reagents and equipment.
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 TSH reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers." This describes a product used in vitro (outside the body) to assess the performance of a diagnostic test (the Elecsys TSH reagents and calibrators).
- Device Description: The description mentions it's a "three level single analyte set of lyophilized, human based materials" that are "assayed in triplicate." This further confirms it's a reagent or control material used in a laboratory setting for 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, strongly suggests this device falls under the same regulatory category, which is IVD.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use, device description, and the nature of the predicate device all point to it being an IVD. It's a product used in a laboratory to ensure the accuracy and reliability of a diagnostic test performed on patient samples.
N/A
Intended Use / Indications for Use
Elecsys CalCheck TSH is intended for use in the quantitative verification of the calibration curve established by the Elecsys TSH reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.
Product codes
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Device Description
The Elecsys CalCheck TSH 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
| AUG 23 1996 | 510(k) Summary |
|---|---|
| Elecsys® CalCheck™ TSH | |
| 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 TSH |
| 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 TSH 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 TSH is intended for use in the quantitative verification of |
| the calibration curve established by the Elecsys TSH reagents and calibrators | |
| on Elecsys 1010 or 2010 immunoassay analyzers. |
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1
510(k) Summary, Elecsys® CalCheck™ TSH, Continued
- Comparison The Boehringer Mannheim Elecsys CalCheck TSH is substantially equivalent 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 TSH 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.