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For the quantitative in vitro determination of Triglycerides in serum. Triglyceride measurements are used in the diagnosis and treatment of diseases involving lipid metabolism and various endocrine disorders e.g Diabetes mellitus, nephrosis and liver obstruction

This in vitro diagnostic device is intended for prescription use only.

Device Description

The Randox Triglycerides kit assay consists of ready to use reagent solutions.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Triglycerides (TRIGS) device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of "acceptance criteria" for the entire device's performance followed by a direct comparison in a single table, but rather describes various performance characteristics and their findings. I will construct a table based on the individual performance criteria and the results presented.

Performance Characteristic	Acceptance Criteria (Implicit/Explicit)	Reported Device Performance
Precision/Reproducibility	Not explicitly stated as a single numerical criterion. Evaluated consistent with C.L.S.I documents EP5-A2. Implied goal is acceptable variability across runs, days, and total.	Lot 1 (RX Daytona Plus): - Sensitivity Pool (13.3 mg/dl): Total CV 13.4% - Serum Pool 1 (96.4 mg/dl): Total CV 2.1% - QC 1 (96.5 mg/dl): Total CV 2.3% - Patient Pool 2 (104 mg/dl): Total CV 2.5% - Patient Pool 1 (117 mg/dl): Total CV 2.5% - Serum Pool 2 (237 mg/dl): Total CV 2.1% - CAL (240 mg/dl): Total CV 2.0% - QC 2 (259 mg/dl): Total CV 1.5% - Serum Pool 3 (326 mg/dl): Total CV 1.6% Lot 2 (RX Daytona Plus): - Sensitivity Pool (17.7 mg/dl): Total CV 11.6% - 801UN QC 2 (97.3 mg/dl): Total CV 3.2% - Serum Pool 1 (111 mg/dl): Total CV 3.6% - 832UE CAL (235 mg/dl): Total CV 3.0% - Serum Pool 2 (252 mg/dl): Total CV 2.6% - 587UE QC 3 (265 mg/dl): Total CV 2.5% - Serum Pool 3 (326 mg/dl): Total CV 3.7% - Serum Pool 4 (514 mg/dl): Total CV 2.8%
Linearity/Assay Reportable Range	Deviation from linearity less than 5%.	Linearity: Slope 0.96, Intercept 3.30, r = 1.000. Reportable Range: 12.4 – 1000 mg/dl. (The linearity study covered up to approximately 1000 mg/dl, and the device has an auto-dilution feature for samples >1000 mg/dL).
Detection Limit	Not explicitly stated as acceptance criteria, but rather defined properties.	LoD: 3.96 mg/dl (based on 240 determinations, 4 low-level samples) LoB: 2.65 mg/dl LoQ: 12.4 mg/dl (lowest concentration at which precision is met)
Analytical Specificity (Interference)	Recovery within ±10% of the initial value of Triglycerides concentration of 150mg/dL and 496mg/dL.	Hemoglobin: No significant interference up to 750mg/dL Total Bilirubin: No significant interference up to 60mg/dL Conjugate Bilirubin: No significant interference up to 60mg/dL Ascorbic Acid: No significant interference up to 3.0mg/dL
Method Comparison with Predicate Device	Not explicitly stated as a single numeric criterion for the regression, but the goal is "substantially equivalent" to the predicate. Implied acceptable correlation (r) and agreement (slope, intercept).	Comparison: Y = 0.97x + 1.22 Correlation coefficient: r = 0.999 (This indicates a very strong positive correlation)

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

Precision/Reproducibility:
- Test Set: Serum-based control material and unaltered human serum samples (some spiked or diluted). Specific numbers of individual patient samples beyond "Pool 1, Pool 2, Pool 3, Pool 4" are not given. For each sample type, 2 replicates per run were performed, twice daily for 20 non-consecutive days, using 2 reagent lots and 2 systems.
- Data Provenance: Not explicitly stated, but implies laboratory testing with control materials and human serum samples. Given the manufacturer is based in the UK, it's likely the testing was done there, but this is not confirmed. It is a prospective study design for precision.
Linearity:
- Test Set: 11 levels prepared from low and high serum pools, each run in replicates of five.
- Data Provenance: Not explicitly stated, but implies laboratory testing with serum pools. Prospective study design.
Detection Limit:
- Test Set: 240 determinations were made, including 4 low-level samples, to determine LoD, LoB, and LoQ.
- Data Provenance: Not explicitly stated, implies laboratory testing. Prospective study design.
Analytical Specificity (Interference):
- Test Set: Spiked interferent samples with corresponding control solutions. Specific number of samples not provided. Triglycerides concentrations of 150 mg/dL and 496 mg/dL were examined.
- Data Provenance: Not explicitly stated, implies laboratory testing. Prospective study design.
Method Comparison:
- Test Set: 109 serum patient samples spanning the range 14.2 to 986 mg/dl. Each tested in singlicate.
- Data Provenance: Not explicitly stated (e.g., country of origin), but states "serum patient samples." Implies retrospective collection of samples or prospective collection for this study.

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

This device (Triglycerides assay) is an in-vitro diagnostic device for quantitative chemical analysis. The "ground truth" for these types of devices is established through analytical reference methods or highly characterized reference materials, not typically by expert consensus of human readers.

No mention of human experts or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set

Not applicable for this type of quantitative analytical assay. Adjudication is typically used in image-based diagnostic studies involving human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study involves assessing the performance of human readers, sometimes with and without AI assistance, and is not relevant for a quantitative chemical assay.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies described (precision, linearity, detection limit, analytical specificity, method comparison) represent the standalone performance of the device/system (RX Daytona plus analyzer with Randox Triglycerides reagent) without human intervention in the analytical measurement process beyond sample loading and general operation.

7. The Type of Ground Truth Used

Precision/Reproducibility, Linearity, Detection Limit, Analytical Specificity: The "ground truth" or reference for these studies refers to the true concentration of triglycerides in the samples (control materials, spiked samples, diluted samples) as determined by a highly accurate method or known values of reference materials.
Method Comparison: The "ground truth" is the results obtained by a legally marketed predicate device (Randox Triglyceride Assay, K923508). For calibrators within the system, Randox Calibration Serum Level 3 is stated to be traceable to the Triglycerides reference method ID-GC/MS. This indicates a high-accuracy chemical method is the ultimate ground truth for calibration.

8. The Sample Size for the Training Set

This document describes a medical device (an in-vitro diagnostic reagent/system) for which "training sets" are not typically applicable in the same way as for AI/machine learning algorithms. The device's performance characteristics are inherent to its chemical formulation and the analytical instrument. There is no mention of a "training set" for an algorithm.

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

Not applicable, as there is no specific "training set" for an algorithm mentioned in the context of this device.

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K Number

K971324

Device Name

TRIGLYCERIDES, TG, OR TRIG

Manufacturer

CAROLINA LIQUID CHEMISTRIES CORP.

Date Cleared

1997-06-20

(71 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

K063841

Intended Use

The Triglycerides Reagent is intended for the quantitative determination of serum triglycerides using the Beckman SYNCHRON CX Clinical System:s. Elevated serum triglyceride levels are associated with increased risk of coronary artery disease, pancreatitis, and numerous genetic lipoprotein disorders.

Device Description

Not Found

AI/ML Overview

Due to the limited information in the provided document, I cannot fulfill all parts of your request. This document is a 510(k) clearance letter for a medical device (Triglycerides Reagent) and does not contain detailed study information regarding acceptance criteria or performance data.

Here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the document. The FDA letter confirms the device is "substantially equivalent" to predicate devices, implying it meets general performance expectations for this type of in-vitro diagnostic. Specific numerical acceptance criteria (e.g., accuracy, precision limits) are not provided.
Reported Device Performance: Not included in the document. The letter acknowledges that the manufacturer provided information to support substantial equivalence, but the actual performance data is not detailed here.

2. Sample size used for the test set and the data provenance:

Sample size: Not mentioned in this document.
Data provenance: Not mentioned in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not mentioned in this document.

4. Adjudication method for the test set:

Not mentioned in this document.

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:

This device is a Triglycerides Reagent, an in-vitro diagnostic (IVD) for quantitative determination of serum triglycerides. It is not an AI-assisted diagnostic imaging device or a device involving human "readers" in the context of imaging interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this type of device.

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

This question also appears to be framed from the perspective of an AI/algorithm-based diagnostic device. As a chemical reagent, the concept of "standalone algorithm performance" doesn't directly apply. The performance of the reagent would be assessed through analytical and clinical validation studies, but not in the sense of a standalone algorithm for image analysis.

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

For an in-vitro diagnostic like a triglycerides reagent, the "ground truth" would typically be established through:
- Reference methods: Comparing the device's results to a more established, highly accurate reference method for triglyceride measurement.
- Clinical correlation: Showing that the triglyceride levels determined by the device correlate with clinical conditions (e.g., risk of coronary artery disease, pancreatitis) or patient outcomes as expected.
- Known concentration controls: Testing the device with samples of known triglyceride concentrations.
- This document does not specify which type of ground truth was used for the submission.

8. The sample size for the training set: