N Protein Standard PY

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K962410 ↗

FDA Product Code

JIX

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the N Protein Standard PY used for in clinical settings?

  The N Protein Standard PY is a lyophilized human serum-based calibrator designed specifically for nephelometric assays in clinical chemistry. It serves as a reference standard to establish accurate calibration curves, ensuring precise measurement of protein concentrations in laboratory testing. This is critical for diagnosing and monitoring conditions where protein levels are clinically relevant, such as autoimmune diseases or inflammatory responses.

• How is the N Protein Standard PY supplied, and is it single-use?

  The N Protein Standard PY is supplied as a lyophilized powder in a single-use format. This means each vial is intended for one-time use only, ensuring consistency and sterility for calibration purposes. After reconstitution, it should not be reused to maintain accuracy and prevent contamination.

• Which Behring Nephelometer systems is this standard compatible with?

  The N Protein Standard PY is explicitly designed for use with Behring Nephelometer systems, including models such as K860894, K892223, and K943997. Compatibility is confirmed for these systems, ensuring reliable calibration for nephelometric protein measurements in clinical chemistry.

• What regulatory pathway was followed for the FDA clearance of this device?

  The N Protein Standard PY received FDA clearance through a 510(k) submission, classified under Class II (device code JIX) and reviewed by the Clinical Chemistry (CH) advisory committee. The clearance (K962410) was granted in 1996 under the Traditional 510(k) pathway, demonstrating substantial equivalence to a predicate device for clinical chemistry applications. The regulatory route confirms its compliance with FDA standards for calibrators in nephelometric assays.