SPECIALTY ASSAYED CONTROL-2

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k100103 B. Purpose for Submission: Change of manufacturing location for a currently marketed device C. Measurand: Abnormal control for Prothrombin Time (PT), activated Partial Thromboplastin Time (aPTT), Factors II, V, VII, X, VIII, IX, XI, XII, Fibrinogen, von Willebrand Factor Antigen, Ristocetin Cofactor, Protein C, Protein S (total and free) D. Type of Test: Hemostasis quality control E. Applicant: Helena Laboratories Corporation F. Proprietary and Established Names: Specialty Assayed Control-2 (S.A.C.-2) G. Regulatory Information: 1. Regulation section: 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: II 3. Product code: GGC, Control, plasma, abnormal 4. Panel: 81 Hematology H. Intended Use: 1. Intended use(s): The S.A.C.-2 is an assayed abnormal control plasma intended for use in clinical laboratories when testing human plasma for the following coagulation deficiencies: Prothrombin time (PT), activated Partial Thromboplastin Time (aPTT), Factor II, V, VII, VIII, IX, X, XI, XII deficiencies, Fibrinogen, von Willebrand Factor antigen, Ristocetin cofactor, Protein C activity, and Protein S activity (total and free). The control material can be used with manual assays, electro-mechanical, or photo-optical clot detection methods. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): Prescription use only 4. Special instrument requirements: Mechanical and photo-optical instrumentation I. Device Description: The S.A.C.-2 is an assayed abnormal control plasma from normal human donors intended for use in clinical laboratories when testing human plasma for the following coagulation deficiencies: Prothrombin time (PT), activated Partial Thromboplastin {1} Time (aPTT), Factor II, V, VII, VIII, IX, X, XI, XII deficiencies, Fibrinogen, von Willebrand Factor antigen, Ristocetin cofactor, Protein C activity, and Protein S activity (total and free). The control is prepared from a normal pool of human plasma collected in $4\%$ sodium citrate. The pool has 0.03M Hepes buffer and is lyophilized to ensure stability of all plasma coagulation factors. All factors are adjusted to be in the abnormal range. # J. Substantial Equivalence Information: 1. Predicate device name(s): Specialty Assayed Control-2 (S.A.C.-2) 2. Predicate 510(k) number(s): k941872 3. Comparison with predicate: | Similarities | | | | | --- | --- | --- | --- | | Item | | Device | Predicate | | Intended Use | The S.A.C.-2 is an assayed abnormal control plasma intended for use in clinical laboratories when testing human plasma for the following coagulation deficiencies: Prothrombin time (PT), activated Partial Thromboplastin Time (aPTT), Factor II, V, VII, VIII, IX, X, XI, XII deficiencies, Fibrinogen, von Willebrand Factor antigen, Ristocetin cofactor, Protein C activity, and Protein S activity (total and free). The control material can be used with manual assays, electro-mechanical, or photo-optical clot detection methods. | | The S.A.C.-2 is an assayed abnormal control plasma which may be used in many facets of testing in the coagulation laboratory | | Analytes | Prothrombin time (PT), activated Partial Thromboplastin time (aPTT), Factor II, V, VII, VIII, IX, X, XI, XII deficiencies, fibrinogen, von Willebrand Factor antigen, Ristocetin cofactor, Protein C activity, and Protein S activity (total and free). | | Same | | Reagent | Lyophilized, buffered human plasma collected in 4% sodium citrate | | Same | | Stability (reconstituted) | 4 hours at 2 - 8°C | | Same | | Packaging | 10 x 1 mL vials | | Same | | Instrumentation | Mechanical and photo-optical instruments | | Same | | Differences | | | | --- | --- | --- | | Item | Device | Predicate | | Analytes (Kinetic) | Analytes no longer available in control F VIII, X, plasminogen, antithrombin III, protein C, a2-antiplasmin | Included in control F VIII, X, plasminogen, antithrombin III, protein C, a2-antiplasmin | | Analytes (Immunological RID) | Analytes no longer available in control Plasminogen, antithrombin III | Included in control Plasminogen, antithrombin III | {2} 3 K. Standard/Guidance Document Referenced. (if applicable): CLSI, EP5-A2-Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guidelines-Second Edition L. Test Principle: The control plasma may be used when performing tests on manual assays, mechanical or photo- optical coagulation instruments in conjunction with suitable commercial reagents. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision studies were performed at Helena Laboratories with three operators, using various reagent systems and analyzers. Duplicate determinations of all analytes were made on five vials from four lots of control, as described in CLSI, EP5-A2. All parameters fell within acceptance criteria (CV of ≤ 15%). b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Assays are acceptable if the mean values are as follows: | Assay | Mean Value | | --- | --- | | Prothrombin Time (PT) | ≥14.0 seconds | | Activated Partial Thromboplastin Time (aPTT) | >35.0 seconds | | Factor Assays | ≤50 % | | Fibrinogen | ≤ 140 mg/dL | | Rocket von Willebrand Factor Antigen | ≤50% | | Rocket Protein C | ≤50% | | Rocket Protein S | ≤50% | | Rocket Protein S (Free) | ≤50% | | Ristocetin Cofactor | ≤50% | | ELISA Protein C | ≤50% | | ELISA Protein S, S (Free), Monoclonal Free S | ≤50% | | ELISA von Willebrand Factor Antigen | ≤50% | Stability studies were performed on each analyte using duplicate determinations on three vials from each of three lots of control. Each analyte was tested at 0 hours and at 4.5 hours with storage at 2 to 8°C. Acceptance criteria for the studies was defined as falling within assigned range and for the 4.5 hour data point to be within 20% of the 0 hour data point. All parameters fell within acceptable performance. d. Detection limit Not applicable e. Analytical specificity: Not applicable f. Assay cut-off: Not applicable {3} N. Proposed Labeling: The labeling is sufficient and satisfies the requirements of 21 CFR Part 809.10. O. Conclusion The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 4