(15 days)
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No
The summary describes a calibration verification material for a laboratory assay, not a device that processes data or images using AI/ML.
No
The device is used to verify the calibration of a testosterone assay, not to diagnose, treat, or prevent a disease or condition. It is a calibration verification product, falling under the category of laboratory quality control materials.
No
Explanation: A diagnostic device is used to detect, diagnose, or monitor a disease or condition. This device, the Elecsys CalCheck Testosterone, is used to verify the calibration of an assay, not to diagnose a patient's medical condition directly. It's a quality control material for an analytical test, not a diagnostic test itself.
No
The device description clearly states it is manufactured using physical components (human serum albumin, testosterone, stabilizers, and preservatives) and is a physical calcheck used to verify calibration, not a software application.
Based on the provided information, the Boehringer Mannheim Elecsys CalCheck Testosterone is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it is used to "verify the calibration assignment for the Boehringer Mannheim Elecsys Testosterone assay." This means it's a reagent used in vitro (outside the body) to ensure the accuracy of a diagnostic test (the Elecsys Testosterone assay).
- Device Description: The description details its composition (human serum albumin, testosterone, stabilizers, preservatives) and how it's manufactured and quality controlled. These are characteristics of a reagent used in laboratory testing.
- Predicate Device: The mention of a predicate device (K924863 Tosoh Medics AIA-Pack FSH Calibration Verification Test) which is also a calibration verification test, further supports its classification as an IVD. Calibration verification materials are a common type of IVD.
While the document doesn't explicitly state "IVD," the intended use and nature of the device clearly align with the definition of an In Vitro Diagnostic product.
N/A
Intended Use / Indications for Use
The Boehringer Mannheim Elecsys CalCheck Testosterone is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Testosterone assay.
Product codes
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Device Description
The Boehringer Mannheim Elecsys CalCheck Testosterone is manufactured using human serum albumin, testosterone, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calchecks are in process checked and quality controlled against ID-GC/MS.
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
The Elecsys® CalCheck™ Testosterone was evaluated for value assignment and stability.
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
JAN 300 1997
510(k) Summary
BOEHRINGER
MANNHEIM
CORPORATION
| 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 |
| 2400 Bisso Lane | |
| Concord, CA 94524-4117 | |
| (510) 674-0690 extension 8413 | |
| Fax number: (510) 674-0690, x8413 |
Contact Person: Yvette Lloyd
Date Prepared: January 13, 1997 |
| 2.
Device Name | Proprietary name: Elecsys CalCheck Testosterone
Common name: Calibration Verification Material
Classification name: Single (specified) analyte controls (assayed + unassayed) |
| 3.
Predicate device | The Boehringer Mannheim Elecsys CalCheck Testosterone is substantially equivalent to the currently marketed Tosoh Medics AIA-Pack FSH Calibration Verification Test. (K924863) |
| 4.
Device Description | The Boehringer Mannheim Elecsys CalCheck Testosterone is manufactured using human serum albumin, testosterone, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calchecks are in process checked and quality controlled against ID-GC/MS. |
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| Summary, Continued | |
|---|---|
| -- | -------------------- |
BOEHRINGER
MANNHEIM
CORPORATION
| 5.
| Intended use | The Boehringer Mannheim Elecsys CalCheck Testosterone is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Testosterone assay. |
|---|---|
| 6. | |
| Comparison | |
| to predicate | |
| device | The Boehringer Mannheim Elecsys® CalCheck™ Testosterone 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 FSH Calibration Verification Test. (K924863) |
| Both products are intended to be used for the verification of calibration for analytes on automated immunoassay analyzers. | |
| 7. Performance | |
| Characteristics | The Elecsys® CalCheck™ Testosterone was evaluated for value assignment and stability. |
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