(14 days)
K/DEN number: Not Found
No
The summary describes a calibration check material for an immunoassay, not a device that processes data or images using AI/ML.
No
The device is described as a "CalCheck" used to verify the calibration assignment for an assay, not for treating or diagnosing a medical condition in a patient.
No
This device is a CalCheck, used to verify the calibration of an assay. It does not directly diagnose a patient's condition.
No
The device description clearly states it is a physical product (manufactured using human serum albumin, follicle stimulating hormone, and stabilizers) used to verify calibration, not a software application.
Based on the provided information, the Boehringer Mannheim Elecsys CalCheck FSH 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 FSH assay." This indicates it is used in a laboratory setting to ensure the accuracy of a diagnostic test (the Elecsys FSH assay).
- Device Description: The description mentions it is manufactured using human serum albumin and follicle stimulating hormone, and is used to check and quality control against another assay kit. This further supports its role in the diagnostic testing process.
- Performance Studies: The mention of performance characteristics being evaluated for "value assignment and stability" is typical for IVD devices, as their accuracy and reliability are crucial for diagnostic purposes.
- Predicate Device: The listing of a predicate device (K924863 Tosoh Medic AIA Pack for FSH) is a strong indicator that this device is being compared to another legally marketed IVD device, which is a common regulatory pathway for IVDs.
While the document doesn't explicitly state "In Vitro Diagnostic," the context of its use in calibrating a diagnostic assay, its composition, and the regulatory information provided (predicate device) all point to it being an IVD.
N/A
Intended Use / Indications for Use
The Boehringer Mannheim Elecsys CalCheck FSH is used to verify the
calibration assignment for the Boehringer Mannheim Elecsys FSH assay.
Product codes
Not Found
Device Description
The Boehringer Mannheim Elecsys CalCheck FSH are manufactured using
human serum albumin, follicle stimulating hormone, and stabilizers. 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® FSH assay kit calibrators (prepared using a
similar procedure).
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
• The Elecsys® CalCheck™ FSH were evaluated for value assignment and
stability.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is 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 | K964829
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 FSH
Common name: Calibration Verification Material
Classification name: Single (specified) analyte controls (assayed + unassayed) |
| 3.
Predicate
device | The Boehringer Mannheim Elecsys CalCheck FSH is substantially equivalent
to the Tosoh Medic AIA Pack for FSH. (K924863) |
| 4.
Device
Description | The Boehringer Mannheim Elecsys CalCheck FSH are manufactured using
human serum albumin, follicle stimulating hormone, and stabilizers. 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® FSH assay kit calibrators (prepared using a
similar procedure). |
| | (Continued on next page |
| 5.
Intended use | The Boehringer Mannheim Elecsys CalCheck FSH is used to verify the
calibration assignment for the Boehringer Mannheim Elecsys FSH assay. |
| 6.
Comparison
to predicate
device. | Performance Characteristics: |
| | • The Elecsys® CalCheck™ FSH were evaluated for value assignment and
stability. |
2
1
510(k) Summary, Continued
. '