(25 days)
No
The summary describes a calibrator for a nephelometer system and does not mention any AI or ML components or functionalities.
No.
The device is described as a calibrator for a diagnostic test, used for establishing reference curves and calibrating a test, rather than for direct treatment or therapy.
No
Explanation: The device is described as a calibrator used to establish reference curves and calibrate a test, not to diagnose a condition directly.
No
The device description clearly states it is a calibrator prepared from human serum (lyophilized) and is intended to be used with Behring Nephelometer Systems, indicating it is a physical substance and not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the establishment of reference curves" for a diagnostic test (N Latex CRP mono test). This directly relates to the calibration of a test used to diagnose or monitor a medical condition.
- Device Description: It is a "calibrator prepared from human serum" and is intended to be used "together with the Behring Nephelometer Systems... for the calibration of the N Latex CRP mono test." Calibrators are essential components of many in vitro diagnostic tests to ensure accurate results.
- Context: The device is used in conjunction with a "N Latex CRP mono test," which is inherently an in vitro diagnostic test for measuring C-reactive protein (CRP) levels in a sample.
Therefore, the N CRP Standard SY, as a calibrator for an in vitro diagnostic test, falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
N CRP Standard SY is intended to be used for the establishment of reference curves.
Product codes
862.1150
Device Description
The proposed calibrator, N CRP Standard SY 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 11 K943997) for the calibration of the N Latex CRP mono test.
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)
Precision and reproducibility: Precision studies using one lot of N CRP Standard SY were run on the Behring Nephelometer. The %CVs ranged from 1.43 to 4.47%.
Stability: Stability was run according to in-house protocols and the control was found stable for at least 12 month lyophilized and 4 weeks once reconstituted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
JUL 16 1996
Attachment 1
510(k) Summary of Safety and Effectiveness for N CRP Standard SY
- 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 19, 1996
2 . Classification: Device Name/
N Protein Standard SY: calibrator Classification Number:
class II (862.1150)
3 . Identification of the legally marketed device:
N Protein Standard SY
4 . Description: Proposed Device
The proposed calibrator, N CRP Standard SY 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 11 K943997) for the calibration of the N Latex CRP mono test.
1
Proposed Device Intended Use: 5 .
N CRP Standard SY is intended to be used for the establishment of reference curves.
Medical device to which equivalence is claimed and comparison 6. information.
The N CRP Standard SY 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 CRP Standard SY like the N Protein Standard SY is a standard in a blood based matrix. Also, both standard are used for the calibration of immunology assays.
The N CRP Standard SY differs from the N Protein Standard SY in that the N Protein Standard SY is a multi-analyte calibrator while the N CRP Standard SY is a single analyte calibrator.
Proposed Device Performance Characteristics: 7 .
Precision and reproducibility:
Precision studies using one lot of N CRP Standard SY were run on the Behring Nephelometer. The %CVs ranged from 1.43 to 4.47%.
Stability
Stability was run according to in-house protocols and the control was found stable for at least 12 month lyophilized and 4 weeks once reconstituted.