(25 days)
No
The summary describes a calibrator for nephelometer systems and does not mention any AI or ML components or functionalities.
No
This device is a calibrator used to establish reference curves for diagnostic tests, not to treat a condition or disease.
No
This device is a calibrator, used to establish reference curves for diagnostic tests performed on a nephelometer. It is not itself a diagnostic device that directly provides diagnostic information about a patient's condition.
No
The device description clearly states it is a calibrator prepared from human serum (lyophilized) with stabilizers and preservative, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the establishment of reference curves" for various protein tests. This directly relates to calibrating diagnostic tests performed in vitro (outside the body) on biological samples (human serum).
- Device Description: The device is a "calibrator prepared from human serum" and is intended to be used with "Behring Nephelometer Systems" for the "calibration of the following tests: Fibrinogen, Antithrombin II, Prothrombin, Plasminogen, alpha1-Antitrypsin, C1 Inhibitor". These are all common diagnostic tests performed on biological fluids.
- Context: Calibrators are essential components of many IVD test systems, ensuring the accuracy and reliability of the results.
The information provided clearly indicates that this device is used in the process of performing diagnostic tests on biological samples, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
N Protein Standard PY is intended to be used for the establishment of reference curves.
Product codes
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Device Description
The proposed calibrator, N Protein Standard PY is a calibrator prepared from human serum (lyophilized) with stabilizers and preservative. It is intended to be used together with the Behring Nephelometer Systems (Behring Nephelometer K860894, Behring Nephelometer 100 K892223 and the Behring Nephelometer II K943997) for the calibration of the following tests:
Fibrinogen Antithrombin II Prothrombin Plasminogen alpha1-Antitrypsin C1 Inhibitor
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
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
Precision studies using one lot of N Protein Standard PY were run on the Behring Nephelometer. The %CVs ranged from 1.01 to 2.29%.
Stability was run according to in-house protocols and the control was found stable for at least 18 months lyophilized and 14 days once reconstituted.
Key Metrics
Not Found
Predicate Device(s)
N Protein Standard SY
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
K 962410
JUL 16 1996
Attachment 1
510(k) Summary of Safety and Effectiveness for N Protein Standard PY
- Manufactures Name, Address, Telephone, and contact person, date of 1 . preparation:
| Manufacture | Behringwerke AG
Postfach 1140
35001 Marburg
Germany |
|-------------|----------------------------------------------------------------------------------------------------------------------|
| Distributor | Behring Diagnostics Inc.
151 University Avenue
Westwood, MA 02090
617-320-3000
Attn: Kathleen Dray-Lyons |
Preparation date:
June 20, 1996
2 . Device Name/ Classification:
| N Protein Standard PY: | calibrator |
|---|---|
| Classification Number: | class II (862.1150) |
3. Identification of the legally marketed device:
N Protein Standard SY
Proposed Device Description: 4 .
The proposed calibrator, N Protein Standard PY is a calibrator prepared from human serum (lyophilized) with stabilizers and preservative. It is intended to be used together with the Behring Nephelometer Systems (Behring Nephelometer K860894, Behring Nephelometer 100 K892223 and the Behring Nephelometer II K943997) for the calibration of the following tests:
Fibrinogen Antithrombin II Prothrombin Plasminogen alpha1-Antitrypsin C1 Inhibitor
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1
5. Proposed Device Intended Use:
N Protein Standard PY is intended to be used for the establishment of reference curves.
Medical device to which equivalence is claimed and comparison 6. information.
The N Protein Standard PY is substantially equivalent in intended use to the N Protein Standard SY. Both standards are in vitro diagnostic reagents intended for use as a calibrator for the establishment of reference curves. The N protein Standard PY like the N Protein Standard SY is a multi-constituent standard in a blood based matrix.
The N Protein Standard PY differs from the N Protein Standard SY in that the N Protein Standard PY are intended for the calibration of coagulation assay while the N Protein Standard SY is intended for the calibration of immunology assays.
7. Proposed Device Performance Characteristics:
Precision and reproducibility:
Precision studies using one lot of N Protein Standard PY were run on the Behring Nephelometer. The %CVs ranged from 1.01 to 2.29%.
Stability
Stablity was run according to in-house protocols and the control was found stable for at least 18 months lyophilized and 14 days once reconstituted.