(28 days)
No
The summary describes a calibration material for an assay, with no mention of AI or ML technology in its function or description.
No
The device is used to verify the calibration of an assay, not to treat, diagnose, cure, or prevent disease.
No
Explanation: This device is a calibration verification material for an AFP assay, not a diagnostic device itself. It is used to ensure the accuracy of the diagnostic assay, rather than to diagnose a condition.
No
The device description explicitly states it is a set of lyophilized, human-based materials, indicating it is a physical reagent, not software.
Based on the provided information, the Boehringer Mannheim Elecsys CalCheck AFP is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's used to "verify the calibration assignment for the Boehringer Mannheim Elecsys AFP assay." This indicates it's used in a laboratory setting to ensure the accuracy of a diagnostic test (the Elecsys AFP assay).
- Device Description: It's a "three level single analyte set of lyophilized, human based materials" that are "assayed in triplicate." This describes a reagent or control material used in an in vitro test.
- Predicate Devices: The predicate devices listed are also "Elecsys® CalCheck™" products for other analytes (CEA and TSH). This suggests a family of products designed for calibration verification in the Elecsys system, which is an IVD platform.
- Performance Studies: The mention of "Specific data on the performance of the test have been incorporated into the draft labeling" further supports its role in a diagnostic process where performance is evaluated.
While the document doesn't explicitly state "IVD," the context of its use in calibrating a diagnostic assay, its composition as a reagent/control material, and its relationship to other CalCheck products strongly indicate it falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Boehringer Mannheim Elecsys CalCheck AFP is used to verify the calibration assignment for the Boehringer Mannheim Elecsys AFP assay.
Product codes
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Device Description
The Elecsys® CalCheck™ AFP is a three level single analyte set of lyophilized, human based materials. After reconstitution, they are assayed in triplicate and the results compared to the target values.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
MAR - 6 1997
510(k) Summary
According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Boehringer Mannheim Corporation 1. Submitter 2400 Bisso Lane name, Concord, CA 94524-4117 address. (510) 827 - 8215 contact Fax number: (510) 687-1850 Contact Person: Patricia Klimley Date Prepared: January 29, 1997 Proprietary name: Elecsys® CalCheck™ AFP 2. Device Name Common name: Calibration Verification Material Classification name: Single (specified) analyte controls (assayed + unassayed) The Elecsys® CalCheck™ AFP is substantially equivalent to the currently 3. Predicate marketed Elecsys® CalCheck™ CEA (K963147). device The Elecsys® CalCheck™ AFP is a three level single analyte set of 4. Device lyophilized, human based materials. After reconstitution, they are assayed in Description triplicate and the results compared to the target values. Continued on next page
1
510(k) Summary, Continued
| 5.
Intended use | The Boehringer Mannheim Elecsys CalCheck AFP is used to verify the
calibration assignment for the Boehringer Mannheim Elecsys AFP assay. | |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 6.
Comparison
to predicate
device | The Elecsys® CalCheck™ AFP is substantially equivalent to the currently
marketed Elecsys® CalCheck™ TSH (K963147).
The following table compares the Elecsys® CalCheck™ AFP with the
predicate devices, Elecsys® CalCheck™ TSH. Specific data on the
performance of the test have been incorporated into the draft labeling in
attachment 5. Labeling for the predicate devices is provided in attachment 6. | |
| Similarities: | | |
| • Configuration: 3 CalCheck levels: low, mid, and high | | |
• Intended use: To verify calibration
Differences:
| Feature | CalCheck AFP | CalCheck TSH |
|---|---|---|
| Matrix type | Human serum | Horse serum |
| Analyte | AFP | TSH |
Continued on next page
2
510(k) Summary, Continued
Performance Characteristics:
- Comparison to predicate
device, (cont.)
• Value assignment and stability