← Product Code [JIX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX) · K962410 # N PROTEIN STANDARD PY (K962410) _Behring Diagnostics, Inc. · JIX · Jul 16, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K962410 ## Device Facts - **Applicant:** Behring Diagnostics, Inc. - **Product Code:** [JIX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX.md) - **Decision Date:** Jul 16, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1150 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use 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. ## Regulatory 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. ## Predicate Devices - N Protein Standard SY ## Reference Devices - Behring Nephelometer ([K860894](/device/K860894.md)) - Behring Nephelometer 100 ([K892223](/device/K892223.md)) - Behring Nephelometer II ([K943997](/device/K943997.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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 000009 {1} 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. 000010 --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K962410](https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K962410) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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