← Product Code [CEP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP) · K964694 # ELECSYS LH ASSAY (K964694) _Boehringer Mannheim Corp. · CEP · Jan 24, 1997 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K964694 ## Device Facts - **Applicant:** Boehringer Mannheim Corp. - **Product Code:** [CEP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP.md) - **Decision Date:** Jan 24, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1485 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for Use Immunoassay for the in vitro quantitative determination of human luteinizing hormone in human serum and plasma. ## Device Story Elecsys® LH Assay is an in vitro diagnostic immunoassay for quantitative determination of human luteinizing hormone (LH) in serum and plasma. Device utilizes sandwich principle: 20 µL sample incubated with biotinylated monoclonal LH-specific antibody and ruthenium-labeled monoclonal LH-specific antibody; complex binds to streptavidin-coated microparticles. Reaction mixture aspirated into measuring cell; microparticles magnetically captured on electrode surface. Voltage application induces chemiluminescent emission measured by photomultiplier. Results calculated via instrument-specific calibration curve generated by 2-point calibration and master curve from reagent bar code. Used on Elecsys® 2010 instrument. Provides clinicians with quantitative LH levels to assist in endocrine assessment. ## Clinical Evidence Bench testing only. Method comparison study (N=166) vs. Enzymun-Test® LH showed high correlation (r=0.993). Precision studies (N=60 per level) demonstrated %CVs ranging from 0.81% to 5.17%. Lower detection limit 0.10 mIU/mL. Linearity 0.1–200 mIU/mL. Interference testing performed for bilirubin, hemoglobin, lipemia, biotin, and rheumatoid factor. Specificity testing showed <0.1% cross-reactivity with FSH, HCG, TSH, HGH, and HPL. ## Technological Characteristics Sandwich immunoassay; electrochemiluminescence detection; streptavidin-coated microparticles; biotinylated monoclonal antibodies; ruthenium complex label. Requires Elecsys® 2010 instrument. Calibration via 2-point method and reagent bar code. Quantitative measurement range 0.1–200 mIU/mL. ## 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 - Enzymum® LH Assay ([K900799](/device/K900799.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} JAN 24 1997 K964694 BOEHRINGER MANNHEIM CORPORATION # 510(k) Summary ## Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. ## 1. Submitter name, address, contact Boehringer Mannheim Corporation 2400 Bisso Lane P.O. Box 4117 Concord, CA 94524-4117 (510) 674 - 0690 extension 8240 FAX 510 687 - 1850 Contact Person: Betsy Soares-Maddox Date Prepared: November 19, 1996 ## 2. Device name Proprietary name: Elecsys® LH Assay Common name: Electrochemiluminescence assay for the determination of human luteinizing hormone (LH). Classification name: System, Test, Human Luteinizing Hormone ## 3. Predicate device We claim substantial equivalence to the Enzymum® LH Assay (K900799). ## 4. Device Description Sandwich principle. Total duration of assay: 18 minutes. - 1st incubation (9min.): 20 µL of sample, a biotinylated monoclonal LH-specific antibody (75 µL) and a monoclonal LH-specific antibody labeled with a ruthenium complex (75 µL)** react to form a sandwich complex. - 2nd incubation (9min.): after addition of streptavidin-coated microparticles (30 µL), the complex becomes bound to the solid phase via interaction of biotin and streptavidin. **Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)₂⁺)** Continued on next page page 26 {1} page 27 # 510(k) Summary, Continued ## 4. Device Description - The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame). - Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code. ## 5. Intended use Immunoassay for the in vitro quantitative determination of human luteinizing hormone in human serum and plasma. ## 6. Comparison to predicate device The Boehringer Mannheim Elecsys® LH Assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Enzymun® LH Assay (K900779). The following table compares the Elecsys® LH Assay with the predicate device, Enzymun® LH Assay. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device is provided in attachment 6. ## Similarities: - Intended Use: Immunoassay for the in vitro quantitative determination of human luteinizing hormone (LH) - Sample type: Serum and plasma - Antibody: Same pair of monoclonal mouse anti-LH antibodies - Solid phase binding principle: Streptavidin/Biotin Continued on next page {2} 510(k) Summary, Continued 6. Comparison to predicate device cont. Differences: | Feature | Elecsys® LH | Enzymun-Test® LH | | --- | --- | --- | | Assay Standardization | Enzmun® LH | WHO # 80/552 | | Detection method | Electrochemiluminescence | ELISA/1-step sandwich assay using streptavidin technology | | Instrument required | Elecsys® 2010 | ES 300 | | Calibration Stability | A calibration is recommended every 7 days if kits is not consumed; 4 weeks with same reagent lot if reagent is consumed within 7 days. | Full calibration required every 2 weeks. One-point calibration required every run. | Performance Characteristics: | Feature | Elecsys® LH | | | Enzymun-Test® LH | | | | --- | --- | --- | --- | --- | --- | --- | | Precision | Modified NCCLS (mIU/mL): | | | Modified NCCLS (mIU/mL): | | | | Level | Low | Mid | High | Low | Mid | High | | N | 60 | 60 | 60 | 120 | 120 | 120 | | Within-Run Mean | 0.54 | 9.38 | 50.72 | 3.6 | 13.5 | 59.5 | | %CV | 1.82 | 1.13 | 0.81 | 2.9 | 3.8 | 1.5 | | Total Mean | 0.54 | 9.38 | 50.72 | 3.6 | 13.5 | 59.5 | | %CV | 5.17 | 1.97 | 1.99 | 4.4 | 4.7 | 3.9 | | Lower Detection Limit | 0.10 mIU/mL | | | 0.50 mIU/mL | | | Continued on next page {3} 510(k) Summary, Continued 6. Comparison to predicate device, (cont.) Performance Characteristics: | Feature | Elecsys® LH | Enzymun-Test® LH | | --- | --- | --- | | Linearity | 0.1 - 200 mIU/mL (with a deviation from a linear line of ±10%) | 0.5 - 150 mIU/mL (with a deviation from a linear line of ±10%) | | Method Comparison | Vs Enzymun-Test® LH Least Squares y = 1.00x - 0.199 r = 0.993 SEE = 1.141 N = 166 Passing/Bablok y = 0.964x + 0.040 r = 0.993 SEE = 0.456 N = 166 | Vs Enzymun-Test® LH Least Squares y = 0.93x + 0.42 r = 0.953 SEE = 5.079 N = 62 | | Interfering substances | No interference at: | No interference at: | | Bilirubin | 25.0 mg/dL | 64.5 mg/dL | | Hemoglobin | 1 g/dL | 1 g/dL | | Lipemia | 1500 mg/dL | 1250 mg/dL | | Biotin | 30 ng/mL | 40 ng/mL | | Rheumatoid Factor | 1500 U/mL | no interference | | Specificity | Level tested % Cross-reactivity | Level tested % Cross-reactivity | | FSH | 300 mIU/mL < 0.1 | 200 mU/mL 0.00 | | HCG | 600 IU/mL < 0.1 | 200 U/mL 0.00 | | TSH | 300 μIU/mL < 0.1 | 100 μU/mL 0.00 | | HGH | 600 μIU/mL < 0.1 | 200 ng/mL 0.00 | | HPL | 13.80 pmol/mL < 0.1 | --- | --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K964694](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K964694) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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