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IL Test™ LAC Screen and IL Test™ LAC Confirm are in vitro diagnostic products for the detection of lupus anticoagulants (a type of phospholipid interfering antibody) in human citrated plasma on IL Coagulation Systems. These tests are indicated for use with patients who have prolonged APTT test of undetermined origin.

This 510(k) is intended to extend the use of these reagents onto another member in the IL family of coagulation analyzers, the ACL Futura (K951891).

IL Test™ LAC Screen and IL Test™ LAC Confirm are in vitro diagnostic products for the detection of lupus anticoagulants (a type of phospholipid interfering antibody) in human citrated plasma on IL Coagulation Systems. This 510(k) is intended to extend the use of these reagents onto another member in the IL family of coagulation analyzers, the ACL Futura (K951891).

Here's a breakdown of the acceptance criteria and study information for the IL Test™ LAC Screen and IL Test™ LAC Confirm (Extension onto the ACL Futura), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria. Instead, it demonstrates performance by comparing the device on the ACL Futura with its performance on an existing ACL 300 reference instrument and assessing precision. The reported performance suggests that the device operates comparably to the predicate device and within acceptable precision limits for diagnostic assays.

• CV of 6.32% (at mean ratio of 2.03)
• CV of 2.36% (at mean normalized ratio of 1.51) |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: n = 53 for the correlation study. "3 levels of plasma" were used for the precision study, but the exact number of runs or individual samples within each run is not specified beyond "multiple runs."
• Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be retrospective, using plasma samples, but this is not definitively stated. There's no mention of a prospective study design.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• The document describes performance studies for an in-vitro diagnostic product, not an imaging or interpretive device that would typically rely on expert human assessment for ground truth. Therefore, no experts were used to establish ground truth in the traditional sense for this type of device. The "ground truth" for this assay lies in the chemical and biological reactivity of the reagents and the accuracy of the instrument's measurement capabilities.

4. Adjudication Method for the Test Set

• None specified. As this is a performance study for an in-vitro diagnostic assay rather than an interpretive clinical assessment, an adjudication method for a test set is not applicable. The measurements are objective numerical results from the instrument.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is an in-vitro diagnostic product validation, not a study involving human readers interpreting results. Therefore, an MRMC study was not performed, and there's no data on the effect size of human readers improving with AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Yes, implicitly. The entire study describes the performance of the device (IL Test™ LAC Screen and IL Test™ LAC Confirm on the ACL Futura analyzer) as a standalone system. The measurements of correlation and precision are direct evaluations of the algorithm/instrument system without human intervention in the measurement process itself.

7. Type of Ground Truth Used

• Reference Instrument Comparison and Known Samples:
  • For the correlation study, the "ground truth" was established by comparing results from the new device/instrument combination (ACL Futura) to a predicate/reference instrument (ACL 300) which is presumably already validated and considered accurate.
  • For the precision study, "3 levels of plasma" were used. These would likely be characterized plasma samples with known or expected ranges of the analyte to assess the reproducibility of the measurements.

8. Sample Size for the Training Set

• Not applicable / Not specified. This document describes the validation of an existing diagnostic reagent on a new instrument platform, not the development or training of a new algorithm (like an AI model). Therefore, there is no "training set" in the context of machine learning. The reagents and assay methodology would have been developed and validated previously.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set for an AI/machine learning algorithm, this question is not relevant to the provided document. The development of the reagents and assay would have involved standard chemical and biological validation methods, which are not detailed here.

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