← Product Code [JJY](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY) · K964065 # N/T PROTEIN CONTROL SL (K964065) _Behring Diagnostics, Inc. · JJY · Nov 6, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY/K964065 ## Device Facts - **Applicant:** Behring Diagnostics, Inc. - **Product Code:** [JJY](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY.md) - **Decision Date:** Nov 6, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1660 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for Use N/T Protein Control SL is intended to be used as accuracy and precision controls in the determination of human serum proteins. ## Device Story N/T Protein Control SL is a liquid human serum-based quality control material containing stabilizers and preservatives. It serves as an accuracy and precision control for immunology assays performed on Behring Nephelometer systems and the TurbiTimeSystem. Laboratory personnel use the control to monitor the performance of protein determination assays. By comparing measured values against expected ranges, clinicians verify the reliability of patient serum protein test results, ensuring diagnostic accuracy for various protein-related conditions. ## Clinical Evidence Bench testing only. Precision and reproducibility studies conducted on Behring Nephelometer and TurbiTimeSystem. Percent CVs ranged from 0.6% to 8.2% on the Nephelometer and 1.6% to 6.1% on the TurbiTimeSystem. Stability testing confirmed shelf life of at least 12 months at +2 to +8°C (unopened) and 15 days at +2 to +8°C (opened). ## Technological Characteristics Liquid human serum-based control material with stabilizers and preservatives. Designed for use with nephelometric and turbidimetric immunoassay systems. Storage requirements: +2 to +8°C. ## Regulatory Identification A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls. ## Predicate Devices - N/T Protein Control SY ## Reference Devices - Behring Nephelometer ([K860894](/device/K860894.md)) - Behring Nephelometer 100 ([K892223](/device/K892223.md)) - Behring Nephelometer II ([K943997](/device/K943997.md)) - TurbiTimeSystem ## 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} Behring Diagnostics Inc. N/T Protein Control SL/L, M and H 510(k) Notification K964065 NOV - 6 1996 # ATTACHMENT 2 ## 510(k) SUMMARY FOR N/T PROTEIN CONTROL SL 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 | | Contact Person: | Laura LeBarron | | Date of Preparation: | October 9, 1996 | 2. Device Name/ Classification: N/T Protein Control SL: quality control material Classification Number: class I (862.1660) 3. Identification of the legally marketed device: N/T Protein Control SY 4. Proposed Device Description: The proposed control, N/T Protein Control SL is a control prepared from human serum (liquid) 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) and with the TurbiTimeSystem™ as accuracy and precision controls for the following tests: | IgG | Ceruloplasmin | | --- | --- | | IgA | RbP | | IgM | Ig/L-chain, Kappa | | C3c | Ig/L-chain, Lambda | | C4 | IgG 1 | | Transferin | IgG 2 | CONFIDENTIAL 000008 {1} Benning Diagnostics Inc. N/T Protein Control SL/L, M and H 510(k) Notification Albumin IgG 3 α1-antitrypsin (α1-proteinase inhibitor) IgG 4 α2-macroglobulin β2-microglobulin Haptoglobin Ferritin α1-acid glycoprotein IgE Pre-albumin (transthyretin) ## 5. Proposed Device Intended Use: N/T Protein Control SL is intended to be used as accuracy and precision controls in the determination of human serum proteins. ## 6. Medical device to which equivalence is claimed and comparison information. N/T Protein Control SL is substantially equivalent in intended use to the N/T Protein Control SY. Both controls are *in vitro* diagnostic reagents intended for use as multi-constituent accuracy and precision controls in the determination of human serum proteins. The N/T Protein Control SY, like the proposed product, is a control in a blood based matrix. Also, both controls are used for accuracy and precision control in immunology assays. The N/T Protein Control SL differs from the N/T Protein Control SY in that the N/T Protein Control SY is a lyophilized standard while the N/T Protein Control SL is a liquid control. ## 7. Proposed Device Performance Characteristics: ### Precision and reproducibility: Precision studies using one lot of N/T Protein Control SL were run on the Behring Nephelometer system and on the TurboTimeSystem™. The percent CV's ranged from 0.6 to 8.2 % on the Behring Nephelometer system and from 1.6 to 6.1 % on the TurbiTimeSystem™. ### Stability Stability was run according to in-house protocols and the control was found to be stable for at least 12 months at +2 to +8°C, as originally packaged and for at least 15 days at +2 to +8°C, once opened. CONFIDENTIAL 00009 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY/K964065](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY/K964065) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com