N Protein Standard PY is intended to be used for the establishment of reference curves.
Device Story
N Protein Standard PY is a lyophilized human serum-based calibrator containing stabilizers and preservatives. Used with Behring Nephelometer systems (K860894, K892223, K943997) to establish reference curves for coagulation assays. Operates in clinical laboratory settings; utilized by laboratory technicians to calibrate nephelometric instrumentation. Output provides reference values for patient sample quantification; facilitates accurate clinical assessment of coagulation parameters.
Clinical Evidence
Bench testing only. Precision studies on Behring Nephelometer yielded %CVs ranging from 1.01% to 2.29%. Stability testing confirmed product stability for at least 18 months in lyophilized form and 14 days post-reconstitution.
Technological Characteristics
Lyophilized human serum-based calibrator; contains stabilizers and preservatives. Designed for use with nephelometric instrumentation. No specific ASTM standards cited.
Indications for Use
Indicated for use as a calibrator for the establishment of reference curves for coagulation assays including Fibrinogen, Antithrombin III, Prothrombin, Plasminogen, alpha1-Antitrypsin, and C1 Inhibitor.
Regulatory Classification
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.)
Special Controls
*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.
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K 962410
JUL 16 1996
Attachment 1
510(k) Summary of Safety and Effectiveness for N Protein Standard PY
1. Manufactures Name, Address, Telephone, and contact person, date of 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
4. Proposed 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
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5. Proposed Device Intended Use:
N Protein Standard PY is intended to be used for the establishment of reference curves.
6. Medical device to which equivalence is claimed and comparison 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
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.
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