← Product Code [CEP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP) · K962041 # ACS LH2 IMMUNOASSAY (K962041) _Ciba Corning Diagnostics Corp. · CEP · Jun 21, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K962041 ## Device Facts - **Applicant:** Ciba Corning Diagnostics Corp. - **Product Code:** [CEP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP.md) - **Decision Date:** Jun 21, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1485 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for Use The intended use of ACS LH2 is for the quantitative determination of LH in serum using the Ciba Corning Automated Chemiluminescence Systems. ## Device Story Two-site chemilumometric (sandwich) immunoassay; utilizes monoclonal mouse anti-LH antibodies. Input: patient serum sample. Process: sample reacts with acridinium ester-labeled antibody and paramagnetic particle-coupled antibody; relative light units (RLUs) measured by ACS:180 system. Output: quantitative LH concentration. Used in clinical laboratory settings; operated by trained laboratory personnel. Results assist clinicians in evaluating reproductive health and endocrine function. ## Clinical Evidence Bench testing only. Accuracy evaluated using 689 samples (range 0.1–96.6 mIU/mL); correlation coefficient (r) = 0.97; regression equation: y = 0.93x + 0.87. Total precision (CV) ranged from 4.0% to 6.0%. Minimum detectable concentration is 0.07 mIU/mL; measurement range up to 200 mIU/mL. ## Technological Characteristics Non-competitive chemiluminescence immunoassay. Reagents: monoclonal mouse anti-LH antibodies (one acridinium ester-labeled, one paramagnetic particle-coupled). Platform: ACS:180 automated chemiluminescence system. Measurement principle: direct relationship between LH concentration and relative light units (RLUs). ## Regulatory Identification A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction. ## Predicate Devices - ACS LH Immunoassay ([K910198](/device/K910198.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} Company Confidential K962041 # JUN 21 1996 ## Summary of Safety and Effectiveness As required by 21 CFR 807.92, the following 510(k) Summary is provided: ### 1. Submitter Information Contact person: Thomas F. Flynn Address: Ciba Corning Diagnostics Corp. 63 North Street Medfield, MA 02052 Phone: 508 359-3877 FAX 508 359-3885 e-mail: thomas.flynn@cibadiag.com Date Summary Prepared: May 24, 1996 ### 2. Device Information Proprietary Name: ACS LH2 Immunoassay Common Name: LH Immunoassay Classification Name: Class I, Luteinizing hormone test system, 21 CFR 862.1485 ### 3. Predicate Device Information Name: ACS LH Immunoassay Manufacturer: Ciba Corning Diagnostics Corp. 510(k) Number: K910198 ### 4. Device Description The Ciba Corning ASC LH2 assay is a two-site chemilumometric (sandwhich) assay which uses constant amounts of two antibodies that have specificity for the intact LH molecule. The first antibody or Lite Reagent is a monoclonal mouse anti-LH antibody labeled with acridinium ester. The second antibody or solid phase is a monoclonal mouse anti-LH antibody covalently coupled to paramagnetic particles. A direct relationship exists between the LH in a sample and the relative light units (RLUs) detected by the ACS:180 systems. ### 5. Statement of Intended Use The intended use of ACS LH2 is for the quantitative determination of LH in serum using the Ciba Corning Automated Chemiluminescence Systems. ACS LH2 510(k) Notification May 22, 1996 2 {1} Company Confidential ## 6. Summary of Technological Characteristics The Ciba Corning LH2 assay is a non-competitive chemiluminescence assay ## 7. Performance Data ### Sensitivity The ACS LH2 assay measures LH concentrations up to 200 mIU/mL with a minimum detectable concentration of 0.07 mIU/mL. ### Accuracy For 689 samples in the range of 0.1 to 96.6 mIU/mL, the correlation between the ACS LH2 assay and the reference method assay is described by the equation: $$ \text{ACS LH2} = 0.93 \times (\text{reference method}) + 0.87 $$ Correlation coefficient (r) = 0.97 ### Precision Total precision (Total % CV) ranged from 4.0 to 6.0. ACS LH2 510(k) Notification May 22, 1996 3 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K962041](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K962041) **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