(14 days)
No
The summary describes a calibration control 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 an assay, not to treat or diagnose a disease.
No
This device is used to verify the calibration of an assay, not to diagnose a medical condition in a patient. It is a quality control tool for an diagnostic assay.
No
The device description clearly states it is manufactured using physical components (human serum albumin, luteinizing hormone, stabilizers, and preservatives) and is a physical reagent used to verify calibration, not a software program.
Based on the provided information, the Boehringer Mannheim Elecsys CalCheck LH 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 LH assay." This indicates it is a reagent or material used in an in vitro diagnostic procedure (the Elecsys LH assay) to ensure the accuracy of the test results.
- Device Description: The description details its composition (human serum albumin, luteinizing hormone, stabilizers, preservatives) and how the analyte is spiked into a matrix. This is typical of a calibrator or control material used in IVD assays. It also mentions quality control against a reference standard (NIBSC 80/552), which is a common practice for IVD components.
- Performance Studies: The mention of evaluating "value assignment and stability" are performance characteristics relevant to IVD calibrators and controls.
- Predicate Device: The inclusion of a predicate device (K924863; Tosoh Medic AIA Pack for FSH) strongly suggests that this device is being compared to a previously cleared IVD device, which is a standard part of the regulatory process for IVDs.
In summary, the function of verifying the calibration of an in vitro diagnostic assay, the nature of the material, and the regulatory context (predicate device) all point to the Boehringer Mannheim Elecsys CalCheck LH being an IVD device.
N/A
Intended Use / Indications for Use
The Boehringer Mannheim Elecsys CalCheck LH is used to verify the calibration assignment for the Boehringer Mannheim Elecsys LH assay.
Product codes
Not Found
Device Description
The Boehringer Mannheim Elecsys CalCheck LH are manufactured using human serum albumin, luteinizing hormone, stabilizers and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled against the Enzymun® LH assay kit calibrators (prepared using a similar procedure), which have been value assigned by comparison to a 2nd International Standard (NIBSC) 80/552.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics:
- The Elecsys® CalCheck™ LH were evaluated for value assignment and stability.
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
| 510(k) Summary | K964830
DEC 16 1996 |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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) 687-1850
Contact Person: Yvette Lloyd |
| | Date Prepared: December 12, 1996 |
| 2.
Device Name | Proprietary name: Elecsys CalCheck LH
Common name: Calibration Verification Material |
| | Classification name: Single (specified) analyte controls (assayed + unassayed) |
| 3.
Predicate
device | The Boehringer Mannheim Elecsys CalCheck LH is substantially equivalent
to the Tosoh Medic AIA Pack for FSH. (K924863) |
| 4 .
Device
Description | The Boehringer Mannheim Elecsys CalCheck LH are manufactured using
human serum albumin, luteinizing hormone, stabilizers and preservatives. The
analyte is appropriately spiked into the calcheck matrix to the correct
calcheck concentration levels. The calcheck are in process checked and quality
controlled against the Enzymun® LH assay kit calibrators (prepared using a
similar procedure), which have been value assigned by comparison to a 2nd
International Standard (NIBSC) 80/552.
|
... ... ......................................................................................................................................................................
කිරීම ප්රධාන කිරීම ප්රධාන අධිකාර පිහිටා විසින් පිහිටා විද්යා පිහිටා විද්යා පිහිටා විද්යා පිහිටා විද්යා පිහිටි ප
12/12/96
4
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1
510(k) Summary, Continued
| 5. Intended use | The Boehringer Mannheim Elecsys CalCheck LH is used to verify the calibration assignment for the Boehringer Mannheim Elecsys LH assay. |
|---|---|
| ----------------- | ---------------------------------------------------------------------------------------------------------------------------------------- |
| 6. Comparison to predicate device. | Performance Characteristics: |
|---|---|
| • The Elecsys® CalCheck™ LH were evaluated for value assignment and stability. |
. .
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