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510(k) Data Aggregation
(273 days)
For the quantitative in vitro determination of LDL-cholesterol concentration in human plasma and serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis and various liver and renal diseases.
This in vitro diagnostic device is intended for prescription use only.
The LDL Cholesterol kit assay consists of ready to use reagent solutions. CATALOGUE NUMBER: CH8312
R1. Enzyme Reagent 1 4 x 20 mL R2. Enzyme Reagent 2 4 x 9 mL
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
Device Name: Direct LDL Cholesterol (LDL)
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|---|
| Precision | Total CV % (within run, among run, among day) | Generally expected to be low for clinical assays, with specific targets often dependent on concentration levels. | QC 1 (92.0 mg/dl): 5.9% total CV QC 2 (135.9 mg/dl): 4.6% total CV QC 3 (186.7 mg/dl): 4.4% total CV Serum pool 1 (65.0 mg/dl): 5.9% total CV Serum pool 2 (154.0 mg/dl): 5.0% total CV Serum pool 3 (200.1 mg/dl): 5.0% total CV Serum pool 4 (343.7 mg/dl): 5.3% total CV |
| Linearity/Reportable Range | Linear Regression Correlation Coefficient (r) | Close to 1.0 (indicating a strong linear relationship) | r = 0.997 |
| Reportable Range | Defined range where results are linear. | 21 - 740 mg/dl | |
| Detection Limit | Limit of Blank (LoB) | Very low, ideally close to zero, to ensure no signal from blank. | 1.94 mg/dl |
| Limit of Detection (LoD) | Low enough to reliably detect the analyte. | 3.19 mg/dl | |
| Limit of Quantitation (LoQ) | Low enough for precise and accurate quantification at low concentrations (typically ≤20% imprecision). | 16.1 mg/dl (with ≤20% imprecision) | |
| Analytical Specificity | Interference (% of Control) | % of Control ± 10% for potential interferents at specified concentrations. | Hemoglobin: No significant interference up to 1000mg/dl.Total Bilirubin: No significant interference up to 60mg/dl.Conjugate Bilirubin: No significant interference up to 60mg/dl.Triglycerides: No significant interference up to 500mg/dl.Intralipid®: No significant interference up to 500mg/dl.Ascorbic Acid: No significant interference up to 6mg/dl. |
| Method Comparison | Linear Regression Correlation Coefficient (r) | Close to 1.0 when compared to a predicate device, indicating substantial equivalence. | r = 0.998 (compared to predicate device) |
| Matrix Comparison | Linear Regression Correlation Coefficient (r) | Close to 1.0 when comparing serum and lithium heparin plasma, indicating equivalent performance across matrices. | r = 0.998 (serum vs. lithium heparin plasma) |
| Traceability | Conformance to reference materials/standards | Traceable to an internal master reference material. Not certified by CRMLN (stated as a disclaimer in labeling). | Traceable to an internal master reference. Labeling states "device has not been certified by the CRMLN." |
Study Details
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Sample size used for the test set and the data provenance:
- Precision (Analytical Performance): 80 determinations for each of 7 pools/QC levels (total of 560 determinations). The samples included control material and "unaltered human serum samples that were spiked with LDL cholesterol concentrations or diluted to achieve concentrations based on established ranges" (e.g., <100mg/dl, 130-159mg/dL, etc.). Data provenance is unspecified, but implied to be from a laboratory setting (prospective testing) rather than patient cohorts, using human serum.
- Linearity/Assay Reportable Range: 11 levels, run in replicates of five on two lots of reagent. This means 11 * 5 * 2 = 110 individual measurements. The samples were prepared using "low and high serum pools." Data provenance is unspecified, but implied to be laboratory-prepared (prospective testing) using serum.
- Detection Limit: 240 determinations (across 4 low-level samples) for LoD. Data provenance is unspecified, but implied to be laboratory-based (prospective testing).
- Analytical Specificity: Two LDL Cholesterol concentrations (96.75 mg/dl and 193.5 mg/dl) were tested against various interferent levels. Each interferent was tested. The specific number of replicates or total determinations per interferent is not specified, but inferred to be multiple to allow for mean value calculation. Data provenance is unspecified, but implied to be laboratory-based (prospective testing).
- Method Comparison with Predicate Device: 139 serum patient samples. Data provenance is unspecified, but these are patient samples, making this a retrospective or prospectively collected patient sample study. The country of origin for these patients is not specified.
- Matrix Comparison: 70 matched patient sample pairs (serum and lithium heparin plasma). Data provenance is unspecified, but these are patient samples, making this a retrospective or prospectively collected patient sample study. The country of origin for these patients is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For this type of in vitro diagnostic device (quantitative measurement of a biomarker), "ground truth" is typically established by reference methods or highly characterized calibrators/control materials, rather than expert human interpretation.
- Precision, Linearity, Detection Limit, Analytical Specificity: Ground truth is based on the known concentrations of analytes in control materials, spiked samples, or reference preparations.
- Method Comparison and Matrix Comparison: The ground truth for comparative studies is the measurement obtained from the "predicate device" or the paired sample (e.g., serum for matrix comparison). This is an analytical comparison rather than a clinical ground truth requiring expert consensus on a diagnosis.
- Therefore, the concept of "number of experts" and "qualifications of experts" used for establishing ground truth as it would apply to imaging or diagnostic interpretation is not applicable here.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Given that this is an in vitro diagnostic device for quantitative measurement, adjudication methods typically used for subjective interpretations (like medical imaging diagnosis) are not applicable. The device provides a numerical output.
- Results are compared to established reference values or predicate device measurements directly. Any discrepancies would be investigated through re-testing or troubleshooting, not through a formal adjudication process between experts primarily for the test set results.
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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:
- No, an MRMC comparative effectiveness study was not done. This type of study applies to devices that assist human readers (e.g., radiologists interpreting images). The "Direct LDL Cholesterol (LDL)" device is an in vitro diagnostic assay that generates a quantitative result directly from a patient sample; it does not involve human "readers" in the context of interpretation that an MRMC study would assess.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this entire submission describes the standalone performance of the Direct LDL Cholesterol (LDL) assay system. It is an automated in vitro diagnostic test that provides a measurement result without human intervention for interpretation beyond operating the instrument and reviewing the numerical output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth used is measurements from reference methods, predicate devices, or traceable calibrator/control values.
- For method comparison, the predicate device's measurements serve as the comparator.
- For precision, linearity, and detection limit, the "ground truth" refers to the known concentrations of the analyte in the prepared samples and controls.
- The device mentions traceability to an "internal master reference material" for calibrators, which is a form of analytical ground truth.
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The sample size for the training set:
- The document does not provide details on a "training set" in the context of machine learning, because this device is a chemical reagent-based assay, not an AI/ML algorithm.
- The study describes the validation of the analytical performance of the reagent system and its associated instrument for quantitative measurement. The concept of training data, as used in AI, does not apply here.
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How the ground truth for the training set was established:
- As there is no "training set" in the AI/ML sense, this question is not applicable. The analytical performance of the assay is based on chemical reactions and spectrophotometric measurements, calibrated against materials with known LDL Cholesterol concentrations.
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(27 days)
The Randox Direct LDL/HDL Cholesterol Calibrator is intended for in vitro diagnostic use in the calibration of Randox HDL and LDL Cholesterol methods. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.
The Randox Direct LDL/HDL Cholesterol Calibrator is supplied in a kit containing 3x1mls vials. The calibrator contains the analytes LDL and HDL. The base matrix used for the manufacture of Randox Direct LDL/HDL Cholesterol Calibrator is Human Serum. The calibrator contains lipoproteins from the various lipoprotein classes including high density lipoproteins.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Randox Direct LDL/HDL Cholesterol Calibrator:
Acceptance Criteria and Device Performance Study for Randox Direct LDL/HDL Cholesterol Calibrator
Based on the provided K1221266 document, the device described is a calibrator, not a diagnostic device that measures patient samples directly. Therefore, the "acceptance criteria" and "device performance" are focused on its role as a calibration standard and its ability to maintain stability and assignable values. The document primarily describes the characteristics of the calibrator and how its values are assigned, rather than presenting a traditional clinical study with outcome-based performance metrics like sensitivity, specificity, or reader improvement.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the typical sense for a diagnostic device (e.g., meeting a certain accuracy threshold against a reference standard). Instead, the performance is demonstrated through its stability and the value assignment process, ensuring it reliably provides known concentrations of analytes for instrument calibration.
Acceptance Criteria (Implied from the document's content):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Calibration of Randox HDL and LDL Cholesterol methods. | The device is supplied as a calibrator for this purpose. The value assignment process demonstrates its ability to reliably provide known values for these analytes across multiple analyzer systems. |
| Composition: Contains analytes LDL and HDL in a human serum matrix, with lipoproteins from various classes. | The device description confirms this composition. |
| Stability (unopened): Stable between +2°C and +8°C until the expiry date. | "Unopened Calibrator is stable until the expiry date printed on the product label when stored between +2℃ and +8℃." |
| Stability (reconstituted): Stable for 5 days at +2°C to +8°C and 1 month at -20°C (frozen once). | "Once reconstituted the components are stable for 5 days at +2℃ and +8℃ and 1 month at -20℃ when frozen once." |
| Value Assignment: Assignable target values for Direct LDL and Direct HDL across a range of common clinical chemistry analyzers. | A table is provided showing target values (mmol/l and mg/dl) for both Direct LDL and Direct HDL on 6 different analyzer systems (Abbott Architect c8000, Beckman Coulter AU640, Hitachi 717, Hitachi 911, Randox RX Daytona, Randox Rx Imola, Siemens Advia 1650). |
| Traceability: Analytes are traceable to specific human plasma products. | Traceability information for Direct HDL (Creative Labs 361-10) and Direct LDL (Creative Labs 360-10) from human plasma is provided. |
| Substantial Equivalence: Demonstrated to be substantially equivalent to the predicate device (Teco Diagnostics Direct HDL/LDL Cholesterol Calibrator). | The "CONCLUSION" explicitly states: "Testing results indicate that the proposed device is substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
For a calibrator, a "test set" in the traditional sense of patient samples is not applicable. The "test set" for this device would refer to the samples used during the value assignment process.
- Sample Size: The document does not specify a distinct "sample size" of individual samples used to determine the values. Instead, it refers to "multiple analysers with reference to a master lot." This implies the calibrator was run numerous times on various instruments. The explicit number of replicates or individual calibrator vials tested for value assignment is not stated.
- Data Provenance: Not explicitly stated, but given Randox Laboratories is a UK-based company and the predicate device comparison table includes international analyzer brands, the testing likely occurred in a controlled laboratory setting (likely in the UK or a partner lab). The data is inherent to the manufacturing and quality control process of the calibrator itself, rather than external patient data. It is a prospective study in the sense that the testing was performed to assign values to the newly manufactured calibrator lots.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For a calibrator, the "ground truth" is established through a hierarchical metrological process, not typically by "experts" reviewing results in the way a radiologist reviews images.
- Number of Experts: Not applicable. The "ground truth" (assigned values) is traceable to established reference materials and methods, often from organizations like the CDC or a certified reference material producer. The document states values are established "with reference to a master lot," which would have its own established traceable values.
- Qualifications of Experts: Not specified or applicable in the context of expert review. The "experts" would be the metrologists and analytical chemists involved in establishing the master lot's values and performing the value assignment on specific instruments, ensuring adherence to rigorous analytical standards.
4. Adjudication Method for the Test Set
Not applicable. As discussed above, the "test set" refers to the value assignment process, which relies on analytical measurements and metrological traceability, not consensus-based adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This is a calibrator, an in-vitro diagnostic reagent, so an MRMC study is not appropriate or presented.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is not applicable to a calibrator. A calibrator does not have an "algorithm" in the sense of an AI or software processing data. Its function is to provide known concentrations for instrument calibration. The "performance" is its ability to consistently deliver these known concentrations and be stable over time.
7. The Type of Ground Truth Used
The "ground truth" for the calibrator's values is established by metrological traceability to a master lot, which in turn is traceable to higher order reference materials and methods. The document explicitly mentions "The assigned values for the direct LDL/HDL Cholesterol Calibrator are established on multiple analysers with reference to a master lot." And the "Traceability" section identifies the specific human plasma products (Creative Labs) as the origin for the analytes.
8. The Sample Size for the Training Set
Not applicable. This device is a calibrator, not an algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is used for this type of device.
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(98 days)
For the quantitative determination of Low-density lipoprotein cholesterol (LDL-C) in human serum or plasma. LDL Cholesterol is recognized as a useful tool in identifying patients who are at a higher risk for coronary heart diseas. High LDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.
Not Found
The provided FDA document is a 510(k) premarket notification for a "Direct LDL Cholesterol Reagent." This is an in vitro diagnostic device, not an AI/ML medical device. Therefore, the concepts of acceptance criteria met by an algorithm, training and test sets, expert ground truth, MRMC studies, or standalone performance do not apply in the context of this document.
The document states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means its performance is considered comparable to existing, legally marketed devices.
The "Indications for Use" section specifies that the device is "For the quantitative determination of Low-density lipoprotein cholesterol (LDL-C) in human serum or plasma."
To adequately respond to your request for AI/ML device-specific information, I would need a document pertaining to an AI/ML medical device.
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(172 days)
Direct LDL Cholesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in serum or plasma. LDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders. For In Vitro Diagnostic Use Only.
The device is a system using the reagent and calibrator in combination to directly measure the LDL-Cholesterol. This is achieved by a homogenous method that directly measures serum LDL-Cholesterol levels without the need for any off-line pretreatment or centrifugation steps. It employs a two-reagent system. The first reagent (R1) contains a combination of detergent, organic and inorganic phosphoric acid compounds, which specifically binds HDL, VLDL and chylomicrons leaving the LDL particles exposed. The second reagent (R2) contains enzymes, which then react with the LDLcholesterol present in the sample.
The provided text describes the acceptance criteria and a study for the "Direct LDL-Cholesterol Liquid Color® and Direct HDL/LDL-Cholesterol Calibrator system" used for quantitative determination of LDL-C.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly from predicate device) | Reported Device Performance |
|---|---|---|
| Method Comparison | Correlation with predicate device (LDL Cholesterol Plus calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche)) | Correlation coefficient of 0.9969 and a regression equation of y = 1.025x - 4.0289 |
| Precision | "within acceptable range" (specific criteria not detailed) | "within acceptable range" |
| Linearity | "acceptable range" (specific criteria not detailed) | Linear to 700 mg/dL |
| Sensitivity | "acceptable range" (specific criteria not detailed) | A change of 0.001 absorbance units is equivalent to approximately 0.4 mg/dL of LDL Cholesterol |
| Interference | "acceptable range" (specific criteria not detailed) | "within acceptable range" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 62 patient samples.
- Data Provenance: The text does not specify the country of origin. It indicates "patient samples" without further details, so it's not possible to definitively classify it as retrospective or prospective based solely on the provided information.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not provided in the text. The ground truth for the device's performance relies on comparison with a predicate device, not on expert consensus.
4. Adjudication Method for the Test Set
- This information is not applicable as the evaluation method was a method comparison study against a predicate device, not a human expert review process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The study was a method comparison of the new device against a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the performance data provided (method comparison, precision, linearity, sensitivity, interference) are for the device's standalone analytical performance. This device is a quantitative, in vitro diagnostic system, and its performance is evaluated based on its direct measurement capabilities, not with human interpretation as part of its core function.
7. The Type of Ground Truth Used
- The ground truth for the study was established by the measurements obtained from the legally marketed predicate device, "LDL Cholesterol Plus (K012287) calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche)." This is a form of comparative reference standard.
8. The Sample Size for the Training Set
- This information is not applicable/not provided. The device is a reagent and calibrator system for direct measurement, not an AI or machine learning algorithm that requires a training set in the conventional sense. The performance data presented are for the analytical validation of the device itself.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable/not provided for the same reasons as in point 8.
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(115 days)
The LDL assay is used for the quantitation of low-density lipoprotein cholesterol levels in human serum or plasma. LDL measurements are used in the diagnosis and treatment of the pathogensis of arteriosclerosis and coronary artery disease.
LDL is an in vitro diagnostic assay for the quantitative determination of low-density lipoprotein cholesterol (LDL) in human serum or plasma. The detergent solubilizes only the non-LDL lipoprotein particles. The cholesterol released is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. Another detergent solubilizes the remaining LDL particles and a chromogenic coupler allows for color formation. The enzyme reaction with LDL cholesterol in the presence of the coupler produces color which is proportional to the amount of LDL cholesterol present in the sample.
Here's an analysis of the provided text regarding the acceptance criteria and study for the LDL assay:
1. Table of Acceptance Criteria and Reported Device Performance
The submission doesn't explicitly define formal "acceptance criteria" with specified thresholds for each performance characteristic. Instead, it presents performance characteristics and asserts that they demonstrate "substantial equivalence" to the predicate device. For the purpose of this table, I will infer the "acceptance criteria" as the performance demonstrated during the study being considered acceptable for substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Method Comparison | Acceptable correlation with predicate device (Roche Cobas Mira Plus Automated Chemistry System) | Correlation coefficient = 0.9546, Slope = 0.984, Y-intercept = 7.466 mg/dL |
| Precision (Total %CV) | Acceptable precision using control material | Level 1/Panel 141 control: 3.3% Level 2/Panel 142 control: 4.0% |
| Linearity | Linear up to a high concentration | Linear up to 600 mg/dL |
| Limit of Quantitation | Low sensitivity value | 1 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size (number of patient samples) used for the method comparison or precision studies. It mentions "two levels of control material" for precision.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies were described as "Comparative performance studies were conducted using the ALCYON™ Analyzer."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of in vitro diagnostic device (IVD) submission. For chemical assays like LDL, the "ground truth" is typically established by reference methods, well-characterized control materials, or clinical outcomes, rather than expert interpretation of images or other subjective data. No experts for ground truth establishment are mentioned.
4. Adjudication Method for the Test Set
This section is not applicable. Since the device measures a chemical analyte, there is no subjective interpretation requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This section is not applicable. MRMC studies are relevant for devices that involve human interpretation (e.g., imaging diagnostics). This device is an automated in vitro diagnostic assay.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance presented is standalone. This device is an automated in vitro diagnostic assay. The performance characteristics described (correlation coefficient, precision, linearity, sensitivity) are inherent to the assay and the analyzer, without human intervention in the measurement process itself. Human involvement would primarily be in sample preparation, running the test, and interpreting the numerical results.
7. The Type of Ground Truth Used
The ground truth for this device's performance is established by comparison to a legally marketed predicate device (Roche Cobas Mira Plus Automated Chemistry System LDL assay) for method comparison, and by using control materials with known values for precision and linearity assessment. The concept of "expert consensus," "pathology," or "outcomes data" as ground truth is not relevant for this type of chemical assay.
8. The Sample Size for the Training Set
This section is not applicable. In vitro diagnostic assays like the LDL assay are typically developed and validated against established chemical principles and reference methods. They do not generally involve "training sets" in the same way machine learning algorithms do, where a model "learns" from a dataset. The formulation and calibration of the assay are based on chemical reactions, and performance is verified through analytical studies.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons mentioned in point 8.
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