Who is the manufacturer of ACS CKMB II IMMUNOASSAY?

Ciba Corning Diagnostics Corp. filed the 510(k) submission for ACS CKMB II IMMUNOASSAY (K962126).

What is the FDA product code for ACS CKMB II IMMUNOASSAY?

JHS. It is classified under 21 CFR 862.1215 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for ACS CKMB II IMMUNOASSAY?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ACS CKMB II IMMUNOASSAY?

Baxter Stratus CK-MB Fluorometric Enzyme Immunoassay (510(k) number not known).

Who can help prepare an FDA 510(k) submission like ACS CKMB II IMMUNOASSAY?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ACS CKMB II IMMUNOASSAY

K962126 · Ciba Corning Diagnostics Corp. · JHS · Jun 21, 1996 · Clinical Chemistry

Device Facts

Record ID	K962126
Device Name	ACS CKMB II IMMUNOASSAY
Applicant	Ciba Corning Diagnostics Corp.
Product Code	JHS · Clinical Chemistry
Decision Date	Jun 21, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1215
Device Class	Class 2

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.

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.

Indications for Use

Indicated for quantitative determination of CK-MB (CK-2) in human serum or plasma samples to aid in the diagnosis of myocardial infarction.

Regulatory Classification

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)

Related Devices

K993068 — VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS · Ortho-Clinical Diagnostics · Oct 4, 1999
K981495 — IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) · Diagnostic Products Corp. · Jun 10, 1998
K041596 — ARCHITECT STAT CK-MB IMMUNOASSAY · Fisher Diagnostics · Jul 21, 2004

Submission Summary (Full Text)

{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