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HemosIL Liquid Heparin: Automated chromogenic assay for the quantitative determination of . unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
HemosIL Heparin Calibrators: For the calibration of the HemosIL Liquid Heparin assay on IL . Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
HemosIL LMW Heparin Controls (Assayed): For the quality control of the HemosIL Liquid . Heparin assay when testing for low molecular weight heparin (LMW) on IL Coagulation Systems (ACL TOP® Family, ACL" ELITE/ ELITE PRO®8/9/10000 and ACL Futura/ACL Advance Systems).
· HemosIL UF Heparin Controls (Assayed): For the quality control of the HemosIL Liquid Heparin assay when testing for unfractionated heparin (UFH) on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
For in vitro diagnostic use.

Device Description

HemosIL Liquid Heparin .
One stage chromogenic assay based on a synthetic chromogenic substrate and on Factor Xa inactivation. Heparin levels in patient plasma are measured automatically on IL Coagulation Systems.
Heparin is analyzed as a complex with antithrombin present in the sample. The concentration of this complex is dependent on the availability of the patient's endogenous antithrombin. When the Heparin - antithrombin complex is formed, two competing reactions take place.

1. Factor Xa is neutralized by heparin-antithrombin complex.
1. Residual Factor Xa is quantified with a synthetic chromogenic substrate. The paranitroaniline released is monitored kinetically at 405 nm and is inversely proportional to the heparin level in the sample.
HemosIL Heparin Calibrators .
Lyophilized calibrators prepared from human citrated plasma by means of a dedicated process at three different heparin concentrations: 0, 0.8 and 2.0 IU/mL and are traceable to the WHO International Standards for LMW and UF Heparin.
HemosIL LMW Heparin Controls (Assayed) .
Lyophilized controls prepared from human citrated plasma by means of a dedicated process at two different LMW heparin concentrations (low and high) for the assessment of precision and accuracy of the Liquid Heparin assay when testing for low molecular weight heparin.
HemosIL UF Heparin Controls (Assayed) .
Lyophilized controls prepared from human citrated plasma by means of a dedicated process at two different UF heparin concentrations (low and high) for the assessment of precision and accuracy of the Liquid Heparin assay when testing for unfractionated heparin.

AI/ML Overview

HemosIL Liquid Heparin Assay, Controls, and Calibrators - Acceptance Criteria & Study Summary

This document describes the acceptance criteria and supporting studies for the HemosIL Liquid Heparin Assay, HemosIL Heparin Calibrators, HemosIL LMW Heparin Controls, and HemosIL UF Heparin Controls, as extracted from the provided 510(k) summary (K090209).

1. Acceptance Criteria and Reported Device Performance

The 510(k) submission primarily demonstrates substantial equivalence through method comparison studies and precision assessments. The acceptance criteria for substantial equivalence are implicitly defined by comparing the new device's performance to that of predicate devices and demonstrating acceptable precision.

The following table summarizes the reported device performance, particularly focusing on precision and method comparison results, which serve as the evidence for meeting implied acceptance criteria for assay performance characteristics relevant to quantitative diagnostic devices. Specific, explicit acceptance criteria (e.g., "CV % must be < X%") are not directly stated in the provided text but are inferred from the presentation of the precision data and the successful substantial equivalence determination by the FDA. The method comparison data implies acceptance if the slope and correlation coefficient (r) are sufficiently close to 1, demonstrating agreement with the predicate.

Table 1: Acceptance Criteria (Implied) and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Precision	CV % (Within run) and CV % (Total) for UFH and LMWH controls should be within acceptable limits for a clinical diagnostic assay.	ACL 8/9/1000/ELITE/ELITE PRO: - UFH Low: Mean 0.39 IU/mL, C.V.% (Within run) 4.0%, C.V.% (Total) 6.7% - UFH High: Mean 0.69 IU/mL, C.V.% (Within run) 1.0%, C.V.% (Total) 3.7% - LMWH Low: Mean 0.49 IU/mL, C.V.% (Within run) 5.5%, C.V.% (Total) 5.7% - LMWH High: Mean 1.31 IU/mL, C.V.% (Within run) 3.3%, C.V.% (Total) 4.0% ACL Futura/ACL Advance: - UFH Low: Mean 0.41 IU/mL, C.V.% (Within run) 4.4%, C.V.% (Total) 4.4% - UFH High: Mean 0.69 IU/mL, C.V.% (Within run) 1.3%, C.V.% (Total) 1.7% - LMWH Low: Mean 0.56 IU/mL, C.V.% (Within run) 2.5%, C.V.% (Total) 3.5% - LMWH High: Mean 1.37 IU/mL, C.V.% (Within run) 1.1%, C.V.% (Total) 1.6% ACL TOP Family: - UFH Low: Mean 0.41 IU/mL, C.V.% (Within run) 2.4%, C.V.% (Total) 3.3% - UFH High: Mean 0.68 IU/mL, C.V.% (Within run) 1.0%, C.V.% (Total) 1.6% - LMWH Low: Mean 0.55 IU/mL, C.V.% (Within run) 3.5%, C.V.% (Total) 4.5% - LMWH High: Mean 1.35 IU/mL, C.V.% (Within run) 1.9%, C.V.% (Total) 2.5%
Method Comparison (Slope)	Slope should be close to 1.0, indicating good agreement with the predicate device.	In-house Study: - ACL ELITE: 0.894 - ACL Advance: 1.067 - ACL TOP: 0.946 Field Sites Study: - ACL ELITE: 1.032 - ACL Advance: 1.007 - ACL TOP: 0.952
Method Comparison (r)	Correlation coefficient (r) should be close to 1.0, indicating a strong linear relationship with the predicate device.	In-house Study: - ACL ELITE: 0.907 - ACL Advance: 0.946 - ACL TOP: 0.958 Field Sites Study: - ACL ELITE: 0.949 - ACL Advance: 0.957 - ACL TOP: 0.978
Linearity	Device should be linear up to 2.0 IU/mL for UFH and LMWH activity across all specified IL Coagulation Systems.	Reported linearity for the new device is Up to 2.0 IU/mL for ACL 8/9/1000/ELITE/ELITE PRO, ACL Futura/ACL Advance, and ACL TOP Family. This is an improvement over the predicate device, which had linearity up to 1.0 IU/mL or 1.1 IU/mL depending on the system.

2. Sample Sizes and Data Provenance for the Test Set

The studies conducted for performance assessment include precision and method comparison.

Precision: "Precision was assessed over multiple runs using the two levels of both UFH and LMWH Controls on representative IL Coagulation Systems." The exact number of samples (individual test results) for precision is not explicitly stated, but it involved multiple runs of two levels of controls for both UFH and LMWH.
Method Comparison - In-house:
- Sample sizes (n):
  - ACL ELITE: 124 samples
  - ACL Advance: 152 samples
  - ACL TOP: 148 samples
- Data Provenance: "samples from patients undergoing heparin therapy." The country of origin is not specified, but the "in-house" designation suggests it was likely from a single internal site, possibly in the USA (where the applicant is located). The data is retrospective in the sense that these are patient samples, but the comparison itself is a prospective analysis of these samples using both devices.
Method Comparison - Field Sites:
- Sample sizes (n):
  - ACL ELITE: 114 samples
  - ACL Advance: 111 samples
  - ACL TOP: 81 samples
- Data Provenance: "samples from patients undergoing heparin therapy." Three field site studies were performed. The country of origin is not specified, but multi-site studies often involve diverse populations. The data is retrospective in the sense that these are patient samples, but the comparison itself is a prospective analysis of these samples using both devices.

3. Number of Experts and Qualifications for Ground Truth

The provided summary does not explicitly mention the use of experts to establish a "ground truth" in the typical sense (e.g., radiological reads). For this type of in vitro diagnostic device (quantitative assay for heparin activity), the "ground truth" for the method comparison studies is typically established by the predicate device's results. The predicate device (HemosIL Heparin) is considered the reference standard against which the new device's performance is compared. Therefore, no external experts were used in this manner.

4. Adjudication Method for the Test Set

Since the ground truth for this type of quantitative assay is established by the reading of the predicate device, there is no mention of an adjudication method involving multiple human readers as described (e.g., 2+1, 3+1). The comparison is directly between the numerical outputs of the new device and the predicate device.

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

No MRMC comparative effectiveness study was mentioned. This type of study is more common for imaging or interpretive diagnostic devices where human readers provide interpretations. For quantitative assays like the HemosIL Liquid Heparin, the focus is on the agreement between the new test results and a reference method/device, and the precision of the new test, rather than human reader improvement with AI assistance.

6. Standalone Performance Study (Algorithm Only)

The entire study focuses on the standalone performance of the HemosIL Liquid Heparin assay (an algorithm-driven instrument-based test) compared to its predicate and its internal precision. There is no human-in-the-loop performance described, as it is an automated chromogenic assay run on IL Coagulation Systems. Therefore, yes, a standalone (algorithm only) performance study was conducted.

7. Type of Ground Truth Used

The ground truth for the method comparison studies was established by the predicate device (HemosIL Heparin). For precision studies, the ground truth for the controls is their assigned nominal values, and the study assesses the reproducibility of the new device's measurements around these values.

8. Sample Size for the Training Set

The provided 510(k) summary does not mention a "training set" in the context of machine learning or AI development. This device is an automated chromogenic assay; its performance is based on chemical reactions and optical detection, not a machine learning model that requires training data in the typical sense. Data used for initial development or optimization of the assay formulation would not be referred to as a "training set" in this context.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" in the context of an AI/ML algorithm for this device, this question is not applicable. The assay's development would involve standard analytical chemistry and immunoassay development pipelines, with "ground truth" being established through reference materials, spiking studies, and established analytical methods.

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