(16 days)
K/DEN numbers: Not Found
No
The summary describes a calibration verification material for an immunoassay, not a device that processes data or images using AI/ML. The components and function are purely chemical/biological.
No.
The device is used to verify the calibration of an assay, not to treat any medical condition.
No
This device is a calibrator used to verify the calibration of an assay, not to diagnose a medical condition in a patient.
No
The device description clearly states it is manufactured using physical components (human serum albumin, progesterone, stabilizers, and preservatives) and is a calibrator, which is a physical substance used in laboratory testing.
Based on the provided information, the Boehringer Mannheim Elecsys CalCheck Progesterone is likely 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 Progesterone assay." This indicates it's a reagent or material used in vitro (outside the body) to assess the performance of another diagnostic test.
- Device Description: The description mentions it's manufactured using human serum albumin, progesterone, stabilizers, and preservatives, and the analyte is spiked into a calibrator matrix. This is consistent with the composition of materials used in in vitro diagnostic procedures.
- Comparison to ID-GC/MS: The value assignment is done by comparison to ID-GC/MS, which is a reference method used to establish the true value of analytes in diagnostic samples. This further supports its role in the diagnostic process.
- Predicate Device: The predicate device listed (Tosoh Medics AIA-Pack FSH Calibration Verification Test) is also a calibration verification material for an in vitro diagnostic assay (FSH). This suggests the Boehringer Mannheim Elecsys CalCheck Progesterone falls into a similar category of IVD devices.
While the document doesn't explicitly state "In Vitro Diagnostic Device," the intended use, description, and comparison to a predicate device strongly indicate that it functions as a component or material used in an in vitro diagnostic procedure.
N/A
Intended Use / Indications for Use
The Boehringer Mannheim Elecsys CalCheck Progesterone is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Progesterone assay.
Product codes
Not Found
Device Description
The Boehringer Mannheim Elecsys CalCheck Progesterone is manufactured using human serum albumin, progesterone, stabilizers, and preservatives. The analyte is appropriately spiked into the calibrator matrix to the correct calibrator concentration levels. The calibrators are in process checked and quality controlled against the Enzymun® Progesterone assay kit calibrators (prepared using a similar procedure) which have been value assigned by comparison to ID-GC/MS.
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™ Progesterone was evaluated for value assignment Characteristics and stability.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 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
| APR -2 1997 | |
|---|---|
| K970984 |
BOEHRINGER
MANNHEIM Summary
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) 687-1850
Contact Person: Yvette Lloyd |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Date Prepared: March 13, 1997 |
| 2.
Device Name | Proprietary name: Elecsys CalCheck Progesterone
Common name: Calibration Verification Material
Classification name: Single (specified) analyte controls (assayed + unassayed) |
| 3.
Predicate device | The Boehringer Mannheim Elecsys CalCheck Progesterone is substantially equivalent to the currently marketed Tosoh Medics AIA-Pack FSH Calibration Verification Test. (K924863) |
| 4.
Device Description | The Boehringer Mannheim Elecsys CalCheck Progesterone is manufactured using human serum albumin, progesterone, stabilizers, and preservatives. The analyte is appropriately spiked into the calibrator matrix to the correct calibrator concentration levels. The calibrators are in process checked and quality controlled against the Enzymun® Progesterone assay kit calibrators (prepared using a similar procedure) which have been value assigned by comparison to ID-GC/MS. |
Continued on next page
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1
Summary, Continued CORPORATION
| 5.
Intended use | The Boehringer Mannheim Elecsys CalCheck Progesterone is used to verify
the calibration assignment for the Boehringer Mannheim Elecsys Progesterone
assay. |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6.
Comparison
to predicate
device | The Boehringer Mannheim Elecsys® CalCheck™ Progesterone is
substantially euivalent 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 | The Elecsys® CalCheck™ Progesterone was evaluated for value assignment |
- I crior mance - The Liccsyse
Characteristics and stability.
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