← Product Code [JHS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHS) · K962126 # ACS CKMB II IMMUNOASSAY (K962126) _Ciba Corning Diagnostics Corp. · JHS · Jun 21, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHS/K962126 ## Device Facts - **Applicant:** Ciba Corning Diagnostics Corp. - **Product Code:** [JHS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHS.md) - **Decision Date:** Jun 21, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1215 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use The intended use of ACS CKMB II is for the quantitative determination of CK-MB (CK-2) in serum or plasma using the Ciba Corning Automated Chemiluminescence Systems. ## Device Story ACS CKMB II is a two-site chemilumometric (sandwich) immunoassay; utilizes monoclonal mouse anti-CK-MB antibody labeled with acridinium ester and monoclonal mouse anti-CK-BB antibody coupled to paramagnetic particles. Input: serum or plasma samples. Operation: automated on Ciba Corning ACS:180 systems; detects relative light units (RLUs) proportional to CK-MB concentration. Output: quantitative CK-MB concentration (ng/mL). Used in clinical laboratory settings by trained technicians. Results assist clinicians in diagnosing myocardial infarction. ## Clinical Evidence Bench testing only. Accuracy evaluated using 1744 samples (0.0-280.0 ng/mL) comparing ACS CKMB II to FEIA reference method; correlation coefficient r=0.96; regression equation: y = 1.01x + 0.24. Sensitivity: minimum detectable concentration 0.18 ng/mL; range up to 300.0 ng/mL. Precision: total % CV 3.0-3.5%. ## Technological Characteristics Non-competitive chemiluminescence immunoassay. Reagents: monoclonal mouse anti-CK-MB (acridinium ester labeled) and monoclonal mouse anti-CK-BB (paramagnetic particle coupled). Automated system (ACS:180) detection of relative light units. Quantitative measurement range 0.18-300.0 ng/mL. ## Regulatory Identification A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. ## Predicate Devices - Baxter Stratus CK-MB Fluorometric Enzyme Immunoassay (510(k) number not known) ## 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 K96a126 # 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 30, 1996 ## 2. Device Information Proprietary Name: ACS CKMB II Immunoassay Common Name: CK-MB Immunoassay Classification Name: Class II, Creatine phosphokinase/creatine kinase or Isoenzymes test system, 21 CFR 862.1215 ## 3. Predicate Device Information Name: Baxter Stratus CK-MB Fluorometric Enzyme Immunoassay Manufacturer: Baxter 510(k) Number: Not Known ## 4. Device Description The Ciba Corning ACS CKMB II assay is a two-site chemilumometric (sandwhich) assay, which uses constant amounts of two antibodies. The first antibody or Lite Reagent is a monoclonal mouse anti-CK-MB antibody labeled with acridinium ester. The second antibody or solid phase is a monoclonal mouse anti-CK-BB antibody covalently coupled to paramagnetic particles. A direct relationship exists between the CK-MB in a sample and the relative light units (RLUs) detected by the ACS:180 systems. The assay is unaffected by increased levels of other CK isoenzymes. ## 5. Statement of Intended Use The intended use of ACS CKMB II is for the quantitative determination of CK-MB (CK-2) in serum or plasma using the Ciba Corning Automated Chemiluminescence Systems. ACS CKMB 510(k) Notification May 30, 1996 2 {1} Company Confidential ## 6. Summary of Technological Characteristics The Ciba Corning CKMB II assay is a non-competitive chemiluminescence assay. ## 7. Performance Data ### Sensitivity The ACS CKMB II assay measures CK-MB concentrations up to 300.0 ng/mL with a minimum detectable concentration of 0.18 ng/mL. ### Accuracy For 1744 samples in the range of 0.0 to 280.0 ng/mL, the correlation between the ACS CKMB II assay and the FEIA reference method assay is described by the equation: $$ \text{ACS CKMB II} = 1.01 \times (\text{FEIA reference method}) + 0.24 $$ Correlation coefficient (r) = 0.96 ### Precision Total precision (Total % CV) ranged from 3.0 to 3.5. ACS CKMB 510(k) Notification May 30, 1996 3 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHS/K962126](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHS/K962126) **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