← Product Code [GGC](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC) · K102552 # HEMOSIL LA POSITIVE CONTROL (K102552) _Instrumentation Laboratory CO · GGC · Apr 5, 2011 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K102552 ## Device Facts - **Applicant:** Instrumentation Laboratory CO - **Product Code:** [GGC](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC.md) - **Decision Date:** Apr 5, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.5425 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use HemosIL® LA Positive Control For use as an LA Positive Quality Control of Lupus Anticoagulant assays (HemosIL Screen/LAC; Silica Clotting Time) on IL Coagulation systems [ACL TOP Family, ACL ELITE®/ELITE PRO/8/9/1000, ACL Futura/ACL Advance/ACL Advance, ACL Classic (100-7000)]. HemosIL® LA Negative Control For use as an LA Negative Quality Control of Lupus Anticoagulant assays (HemosIL Screen/LAC; Silica Clotting Time) on IL Coagulation systems [ACL TOP Family, ACL ELITE®/ELITE PRO/8/9/1000, ACL Futura/ACL Advance/ACL Advance, ACL Classic (100-7000)]. The controls assess the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays. ## Device Story Lyophilized plasma controls; used to verify precision/accuracy of Lupus Anticoagulant (LA) assays. Positive control derived from human donors with anti-phospholipid antibodies; negative control derived from pooled human citrated platelet-poor plasma. Used on IL Coagulation systems (ACL TOP, ELITE, Futura, Advance, Classic lines). Healthcare providers reconstitute lyophilized vials; run on automated coagulation analyzers alongside patient samples. Output consists of normalized ratio (NR) values compared against established ranges. Ensures assay performance reliability for clinical decision-making regarding LA status. ## Clinical Evidence Bench testing only. Precision/reproducibility evaluated per CLSI EP05-A2 across seven instrument platforms (n=80 samples per control). Within-run CV <6%; total CV ≤6%. Normalized ratios confirmed for value assignment (N=288 per control). No clinical patient data. ## Technological Characteristics Lyophilized human plasma preparations. Positive control: human donor plasma with anti-phospholipid antibodies and buffer. Negative control: pooled human citrated platelet-poor plasma with buffer. Reconstituted stability: 24 hours at 2-8°C. Designed for use on IL Coagulation systems (ACL TOP, ELITE, Futura, Advance, Classic series). ## Regulatory Identification A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays. ## Special Controls *Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. ## Predicate Devices - LAtrol Abnormal Control and LAtrol Normal Control ([K935254](/device/K935254.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} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k102552 B. Purpose for Submission: Clearance for HemosIL® LA Positive Control and HemosIL® LA Negative Control for Lupus Anticoagulant assays C. Measurand: Controls for Lupus anticoagulant (LA) D. Type of Test: Assayed controls E. Applicant: Instrumentation Laboratories Co. F. Proprietary and Established Names: HemosIL® LA Positive Control HemosIL® LA Negative Control G. Regulatory Information: 1. Regulation section: 21 CFR 864.5425 - Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: GGN (Plasma, Coagulation Control) GGC (Plasma Control, Abnormal) GIZ (Plasma Control, Normal) 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): HemosIL® LA Positive Control For use as an LA Positive Quality Control of Lupus Anticoagulant assays (HemosIL Screen/LAC; Silica Clotting Time) on IL Coagulation systems [ACL TOP Family, ACL ELITE®/ELITE PRO/8/9/1000, ACL Futura/ACL Advance/ACL Advance, ACL Classic (100-7000)]. HemosIL® LA Negative Control For use as an LA Negative Quality Control of Lupus Anticoagulant assays (HemosIL Screen/LAC; Silica Clotting Time) on IL Coagulation systems [ACL TOP Family, ACL ELITE®/ELITE PRO/8/9/1000, ACL Futura/ACL Advance/ACL Advance, ACL Classic (100-7000)]. The controls assess the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays. 2. Indication(s) for use: Same as above 3. Special conditions for use statement(s): For prescription use only {1} 4. Special instrument requirements: For use on IL Coagulation systems [ACL TOP Family, ACL ELITE®/ELITE PRO/8/9/1000, ACL Futura/ACL Advance/ACL Advance, ACL Classic (100-7000)] I. Device Description: HemosIL® LA Positive Control is a lyophilized preparation from human donors exhibiting the presence of anti-phospholipids antibodies with added buffer. The device consists of ten-1ml vials of lyophilized controls per package. HemosIL® LA Negative Control is a lyophilized preparation using human citrated platelet-poor plasma to make pooled normal plasma with added buffer. The device consists of ten-1ml vials of lyophilized controls per package. J. Substantial Equivalence Information: 1. Predicate device name(s): American Diagnsotica LAtrol Normal Control American Diagnsotica LAtrol Abnormal Control 2. Predicate 510(k) number(s): k935254 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | | HemosIL® LA Positive Control | LAtrol Abnormal Control | | Intended Use | For use as a positive quality control for HemosIL Lupus Anticoagulant assays | Same | | Analyte Tested | Lupus Anticoagulant | Same | | Format/Matrix | Lyophilized Plasma | Same | | Differences | | | | --- | --- | --- | | Item | Device | Predicate | | | HemosIL® LA Positive Control | LAtrol Abnormal Control | | Constituent Material | Lyophilized preparation from human donors exhibiting the presence of anti-phospholipids antibodies with added buffer. | Lyophilized preparation of a lupus anticoagulant plasma with buffer. | | Reconstituted Stability | Stable for 24 hours at 2-8°C | Stable for 8 hours at 2-8°C | | Test System | IL coagulation system: [ACL TOP Family, ACL ELITE®/ELITE PRO/8/9/1000, ACL Futura/ACL Advance/ACL Advance, ACL Classic (100-7000)]. | Manual tilt-tube method or semi-automated method using ST4 or BBL fibrometer, and most automated analyzers | {2} | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | | HemosIL® LA Negative Control | LAtrol Normal Control | | Intended Use | For use as a negative quality control for HemosIL Lupus Anticoagulants assays | Same | | Analyte Tested | Lupus Anticoagulant | Same | | Format/Matrix | Lyophilized Plasma | Same | | Differences | | | | --- | --- | --- | | Item | Device | Predicate | | | HemosIL® LA Negative Control | LAtrol Normal Control | | Constituent Material | Lyophilized preparation using human citrated platelet-poor plasma to make pooled normal plasma with added buffer. | Lyophilized preparation of multi-donor normal plasma with buffer. | | Reconstituted Stability | Stable for 24 hours at 2-8°C | Stable for 8 hours at 2-8°C | | Test System | IL coagulation system: [ACL TOP Family, ACL ELITE®/ELITE PRO/8/9/1000, ACL Futura/ACL Advance/ACL Advance, ACL Classic (100-7000]. | Manual tilt-tube method or semi-automated method using ST4 or BBL fibrometer, and most automated analyzers | # K. Standard/Guidance Document Referenced (if applicable): Guidance Document on Assayed and Unassayed Quality Control Material, June 7, 2007. - CLSI EP05-A2: Evaluation of Precision Performance of Quantitative Measurement Methods, 2nd Edition, 2004. - CSLI C3-A4: Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline. Fourth Edition, Vol.26 No. 22 # L. Test Principle: LA Positive control and the LA Negative control are lyophilized preparations from human donor with anti-phospholipid antibodies with added buffer and human citrated platelet poor plasma used to assess the precision and accuracy of Lupus Anticoagulant (LA) assays performed on the IL Coagulation instrument platform using HemosIL LA reagents (LA Screen and Confirm). # M. Performance Characteristics (if/when applicable): # 1. Analytical performance: a. Precision/Reproducibility: Repeatability was demonstrated by testing within-run and between-run precision on two lots each of lyophilized controls according to procedures outlined under CLSI E5-A2 guidelines. Reproducibility was conducted on two lots of each level of control. A total of 80 samples were run based on two replicates per run for two runs per day over 20 days per instrument over seven instrument platforms. Precision studies for both controls were run with the designated assays on the following IL Coagulation instrument platforms: {3} - ACL TOP: HemosIL LAC Screen/LAC Confirm & HemosIL Silica Clotting Time - ACL TOP 500 CTS: HemosIL LAC Screen/LAC Confirm & HemosIL Silica Clotting Time - ACL 1000: HemosIL LAC Screen/LAC Confirm & HemosIL Silica Clotting Time - ACL Advance: HemosIL LAC Screen/LAC Confirm & HemosIL Silica Clotting Time - ACL 6000: HemosIL LAC Screen/LAC Confirm Only - ACL 3000: HemosIL LAC Screen/LAC Confirm Only - ACL 300+: HemosIL LAC Screen/LAC Confirm Only Summary of precision study is as follows: | LA Controls | n | Within Run CV | Total CV | Normalized Ratio (run) | | --- | --- | --- | --- | --- | | LA Negative Control | 80 | <6% | ≤ 6% | <1.1 for LAC <1.16 for SCT | | LA Positive Control | 80 | <6% | ≤ 6% | ≥ 1.40 for LAC and SCT | b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Stability: The lyophilized shelf life for the LA controls are stable at 2-8°C up to 24 months. After reconstitution, the LA controls are stable at 2-8°C for up to 24 hours. The on board stability of LA controls after reconstitution are as follows: - 24 hours on the ACL TOP Family - 4 hours on the ACL ELITE/ELITE PRO 8/9/1000 - 4 hours on the ACL Futura/ACL Advance - 4 hours on the ACL Classic (100-7000) System d. Detection limit: Not applicable e. Analytical specificity: Not applicable f. Assay cut-off: Not applicable 2. Comparison studies: a. Method comparison with predicate device: Not applicable b. Matrix comparison: Not applicable 3. Clinical studies: a. Clinical Sensitivity: Not applicable b. Clinical specificity: {4} Not applicable c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: The expected values were based on determined normalized ratios (NR) from the product inserts for IL LA test assays (LA Screen and LA Confirm) on IL Coagulation systems [ACL TOP Family, ACL ELITE®/ELITE PRO/8/9/1000, ACL Futura/ACL Advance/ACL Advance, ACL Classic (100-7000]. Expected values were determined for the LA Positive and Negative controls using HemosIL LAC Screen and Confirm, and HemosIL Silica Clotting reagents verified by a control acceptance protocol. The expected values were determined from LA Negative control $(N = 288)$ and Positive control $(N = 288)$ studies applied on three LA assays over four instrument platforms to confirm value assignment: | Controls | Expected Values | | | | --- | --- | --- | --- | | | Instrument Family | LAC Screen/Confirm | Silica Clotting Time | | LA Negative Control | ACL TOP Line | <1.1 | <1.16 | | LA Negative Control | ACL Advance, Elite, Elite PRO, Futura, Classic Lines | <1.2 | No testing for the Classic line | | LA Negative Control | ACL Elite, Elite PRO | | <1.20 | | LA Negative Control | ACL Advance, Futura | | <1.24 | | LA Positive Control | ACL Advance, Elite, Elite PRO, Futura, Classic Lines | ≥1.40 | No testing for the Classic line ≥1.40 | # N. Proposed Labeling: The labeling is sufficient and it 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. --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K102552](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K102552) **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. 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