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The HISCL TSH assay Kit is a magnetic particle chemiluminescent enzyme immunoassay (CLEIA) for the quantitative determination of TSH levels in human serum using the Automated Immunoassay System HISCL-800. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The HISCL TSH Calibrator is used for calibrating the HISCL TSH Assay Kit on the Automated Immunoassy System HISCL-800.

The HISCL Immuno Multi Control is used for quality control of the Assay Kit on the Automated Immunoassay System HISCL-800.

Device Description

The HISCL-800 is a fully automated floor model random access immunoassay system that can quantitatively or qualitatively analyze samples for minute traces of a variety of chemistry analytes. The HISCL-800 has a maximum through-put of 100 tests / hour with an analysis time per analyte of 17 minutes and has capacity for 24 on board reagent sets in the cooled reagent storage. Reagent tracking utilizes RFID technology. Using six 5-sample racks, the HISCL-800 has a walk-away capacity for 30 specimens and one STAT sample loading position. An onboard mixer automatically mixes the magnetic particle reagent as needed. The analyzer has a dedicated sample arm which uses disposable tips and three reagent dispensing arms. The HISCL-800 employs chemiluminescent enzyme technology based on CDP-Star™ chemiluminescent substrate. The analyzer has the capacity to run both one-step and two-step sandwich immunoassays.

The HISCL TSH Assay Kit measures TSH based on the chemiluminescent enzyme immunoassay method with CDP-Star® chemiluminescent substrate. The assay utilizes a 1step sandwich immunoassay.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them, structured according to your requested information:

Device: Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control.
Indication for Use: Quantitative determination of TSH levels in human serum for the diagnosis of thyroid or pituitary disorders.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as a separate table with pass/fail metrics. However, the document describes the performance targets and the results obtained for various non-clinical and clinical studies. I will synthesize these into a table format based on the descriptions.

Performance Metric	Acceptance Criteria (Inferred/Target)	Reported Device Performance
Non-Clinical Performance
20-Day Precision (Within-Laboratory %CV)	(Inferred to be within acceptable clinical laboratory limits, generally 200 µIU/mL when undiluted or diluted appropriately.
Spike Recovery	Recoveries such that native samples reflect a 10x increase (100 µIU/mL spike) and 100x increase (1,000 µIU/mL spike) within 20% tolerance.	All data found to be acceptable (met the targeted recovery within 20% tolerance).
Sample Storage Stability	Stable at various conditions (refrigerated, freeze-thaw cycles, long-term frozen) for specified durations.	Samples stable for every sample, at each condition, and at each time point (refrigerated up to 8 days, multiple freeze-thaws up to 5x, long-term storage at -20°C up to 3 months).
Sample On-board Stability	Percent differences within 10% of the Time 0 time point.	Percent differences were all within 10% of the Time 0 time point (up to 8 hours on the instrument).
Reagent, Calibrator, and Control Stability	Specified shelf life for open/closed vials.	HISCL TSH Assay Kit: Expiration Date (closed 2-8°C), 30 days (open/on board 2-8°C).
HISCL TSH Calibrators: Expiration Date (closed 2-8°C), 60 days (open 2-8°C).
HISCL Immuno Multi Control: Expiration Date (closed 2-8°C), 60 days (reconstituted -20°C), 7 days (reconstituted 2-8°C), 8 hours (reconstituted 8-30°C).
Sample Carryover	No carryover observed.	No carryover was observed.
Linearity/Reportable Range	High correlation coefficient (R²) for expected vs. observed values over the reportable range of 0.008 µIU/mL to 75 µIU/mL.	Regression equation: y = 0.994x + 8.115 x 10^-3; Correlation coefficient: R² = 1.00 (evaluated from 0.001 to 257.887 µIU/mL, ensuring linearity within the reportable range).
Clinical Performance
Reference Range Study (Central 95% interval)	Establish a reference range consistent with expected physiological values for healthy individuals.	0.446 µIU/mL and 4.780 µIU/mL (for N=127, age 21-70).
Method Comparison Study (Agreement with Predicate)	High correlation (slope close to 1, y-intercept close to 0, R² close to 1).	Deming regression: slope 0.950 (95% CI: 0.936 to 0.964); y-intercept -0.0019 (95% CI: -0.0056 to 0.0018); Correlation coefficient 0.993 (95% CI: 0.991 to 0.995).

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

20-Day Precision: 5 samples (2 controls, 3 serum samples), each tested 80 times (20 days * 2 runs/day * 2 duplicates).
Limit of Blank: 4 zero TSH samples, tested 80 times each (not specified if these are human serum or contrived).
Limit of Detection: 5 low TSH samples (contrived by adding TSH to diluent), tested 40 times each (8x/day for 5 days).
Limit of Quantitation (Functional Sensitivity): 7 low TSH samples (4 human pools, 3 serial dilutions of TSH low control), tested 40 times each (twice a day for 20 days).
Interference & Cross-reactivity: 2 serum samples (low and high TSH), tested in triplicate for each interferent/cross-reactant level.
High Dose Hook Effect: 5 high concentration TSH samples (~2,000 µIU/mL), tested in triplicate for each dilution level (neat + 3 serial dilutions).
Spike Recovery: 4 native low TSH serum samples, tested in triplicate with two different spike levels and non-spiked.
Sample Storage Stability: 14 serum samples (10 neat, 4 spiked), tested in replicates of three at various time points/conditions. Provenance: "collected from donors."
Sample On-board Stability: 14 serum samples (10 neat, 4 spiked), tested in replicates of three at various time points. Provenance: "collected from donors."
Sample Carryover: 3 contrived TSH serum pools (low, middle, high), tested in a specific sequence (4 sets/day for 5 days).
Linearity/Reportable Range: 39 intermediate samples (contrived mixture of high and low serum samples). Range tested: 0.001 to 257.887 µIU/mL.
Reference Range Study: N = 127 (65 males, 62 females), Age range 21 and 70 years. Provenance: Clinical specimens from an external clinical laboratory. Presumed prospective collection given the nature of a reference range study.
Method Comparison Study: N = 165. TSH range = 0.009 µIU/mL to 74.604 µIU/mL. Provenance: Clinical specimens from an external clinical laboratory, likely prospective or a mix of prospective/retrospective samples with TSH values across the range.

Data Provenance (General):

Non-Clinical Studies: Primarily in-house studies (in-house stated for precision, prepared for some contrived samples). Samples for stability were collected from donors.
Clinical Studies: Performed by an "external clinical laboratory with clinical specimens." This indicates real-world patient samples. The studies are described as a "reference range study" and a "method comparison study," typically implying prospective or at least recently collected and processed samples within a clinical setting to assess performance against a predicate and establish norms.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish ground truth for the device's performance characteristics. This is common for IVD devices for quantitative analytes.

For performance studies (precision, LoB, LoD, etc.): Ground truth is established by the analytical measurement principles, reference methods, or gravimetric/volumetric preparation of standards. Not typically expert consensus.
For clinical studies (reference range, method comparison): The ground truth for the method comparison is the measurement of the predicate device (Siemens ADVIA Centaur TSH3-Ultra Assay). For the reference range, it is derived statistically from a healthy population.

4. Adjudication Method for the Test Set

Not applicable. For quantitative immunoassay devices like TSH, results are numerical. Ground truth is either the value from a reference method, an assigned value of a certified reference material, or a statistically derived value (e.g., in linearity or reference range studies). This does not involve expert adjudication as one would see in image-based diagnostic AI.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a standalone quantitative immunoassay system, not an AI-assisted diagnostic device that involves human "readers" interpreting output for a diagnostic decision in the same way clinical imaging often does.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the studies described are all standalone performance evaluations of the HISCL-800 Automated Immunoassay System and HISCL TSH Assay Kit. The system quantifies TSH levels automatically, and the performance metrics (precision, accuracy, linearity, interferences, etc.) are inherent to the device's analytical capabilities without human interpretative input into the final TSH value provided by the machine.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for various studies includes:

Reference Method Comparability: For the method comparison study, the Siemens ADVIA Centaur TSH3-Ultra Assay (the predicate device) served as the reference method or comparative standard.
Assigned Values: For calibrators and controls with known concentrations (e.g., based on WHO Standard 80/558 for calibrators).
Predefined Concentrations: For contrived samples in linearity, LoD, LoQ, interference, cross-reactivity, and hook effect studies where known amounts of TSH or interferents were added.
Statistical Derivation: For the reference range, values were statistically derived from a healthy population.
Analytical Measurement: For precision, stability, and carryover studies, the ground truth is the inherent analytical performance and measurement of the device itself.

8. The Sample Size for the Training Set

The provided document describes a 510(k) submission for an in vitro diagnostic (IVD) quantitative immunoassay system. It does not mention any "training set" in the context of machine learning or AI. The development of such systems typically involves extensive internal validation and optimization studies during the R&D phase, but these are not usually structured as "training sets" in the AI sense for regulatory submissions.

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

As no "training set" (in the AI/ML context) is explicitly described, the method for establishing its ground truth is not detailed. For traditional IVD development, reagent formulations are optimized and instrument parameters refined based on various scientific principles and experimental data to achieve target performance specifications.

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