Search Results
Found 4 results
510(k) Data Aggregation
(27 days)
THERMO DMA, INC.
The Thermo DMA Data-Cal Calibrator is intended for use in the calibration of clinical chemistry assays.
Thermo DMA's Data-Cal is intended for use as a reference material in the single point calibration of clinical chemistry procedures.
Here's an analysis of the provided text regarding the Thermo DMA Data-Cal calibrator, structured to answer your questions.
Description of Acceptance Criteria and Device Performance Study
The primary objective of the studies described in the document is to demonstrate the substantial equivalence of the new Thermo DMA Data-Cal calibrator to its predicate device, the Data Medical Associates (DMA) Data-Cal. This is achieved through comparisons of intended use, format, stability, and most critically, performance in clinical chemistry assays, particularly regarding accuracy and traceability.
The acceptance criteria are implicitly defined by two main aspects:
- Substantial Equivalence: The new calibrator's features and performance should be comparable to the legally marketed predicate device. This is assessed through direct comparison of features and performance characteristics.
- Accuracy and Traceability: The calibrator's assigned values for various analytes should be accurate and traceable to established standards, primarily NIST (National Institute of Standards and Technology) where available. An explicit criterion for performance verification against a secondary calibrator (Verichem) or NIST SRM #909b was set as "to obtain the set point... within +/- 10%".
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Intended use, format, and physical state should match the predicate device. | Met. The new calibrator's intended use ("For the quantitative calibration of clinical chemistry assays"), format ("Pooled human sera with constituents added as required to obtain levels"), and physical state ("lyophilized") are identical to the predicate device. |
| Stability | * Storage Stability: Stable at 2-8°C until expiration date (implied to be equivalent or better than predicate). * Reconstitution Stability: Stable for set number of days after reconstitution (new device proposed 7 days vs. predicate 5 days). | Met. |
| * Accelerated Stability (36 months at 2-8°C equivalent to 21.5 days at 37°C): Performance after accelerated aging should be comparable to non-stressed material and maintain proposed reconstitution stability. * Real-Time Stability: Material stored at 2-8°C should remain stable until its expiration date. | * Accelerated Stability: The calibrator was reconstituted and compared to non-stressed material after being stressed at 37°C for 21.5 days (equivalent to 36 months at 2-8°C). The proposed 7-day reconstitution stability was validated. * Real-Time Stability: The manufacturer documents real-time stability for equivalent calibrators, and samples of the new calibrator will be held for real-time testing. | |
| Value Assignment & Variability | Vial-to-vial variability should be properly evaluated and consistent with predicate devices. | Met. Duplicate tests were run on ten vials, and results were consistent with those obtained from equivalent predicate devices. |
| Accuracy & Traceability | * Analyte values should be traceable to NIST primary standards where available. * Performance verification against secondary calibrator (Verichem) or NIST SRM #909b should be within +/- 10%. | Met (mostly). * Analyte values are traceable to NIST where available (12 specific SRMs listed). Primary standards were produced in-house using NIST SRMs. Where NIST SRMs were unavailable, high purity materials and established clinical chemistry procedures were used, with an established history of known performance. * The +/- 10% criterion was met in all cases during performance transfer, except for instances where the value established fell below one, and specifically for Triglyceride SRM #909b, Level 1 which recovered 14% (outside 10%). Thermo DMA rationalizes that the triglyceride set point is valid because the Verichem material recovered within 6% and the previous lot of calibrator recovered its established set point. * Samples of the predicate calibrator were also included, and their results were consistent with historical performance. |
| Comparative Performance | Results obtained with the new calibrator should not have significant differences compared to the predicate device in clinical chemistry assays. | Met. "No significant differences exist between the results obtained on tests conducted utilizing the Thermo DMA Data-Cal when compared to those obtained when utilizing the predicate device in these studies." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Value Assignment & Variability: Duplicate tests on ten vials were performed to evaluate vial-to-vial variability.
- Analyte Set Points: Twenty replicates were used to determine the mean analyte set points for the calibrator on the Roche Hitachi 717.
- Performance Transfer: The number of samples for the performance transfer is not explicitly stated as a single number but involved testing the secondary calibrator as an unknown, then using it to calibrate an assay with a primary calibrator (where possible), and including vendor calibrators (Verichem) and NIST SRM #909b. This implies multiple runs for each analyte tested.
- Stability: Not explicitly quantified in terms of "test set" samples, but involved 21.5 days of accelerated aging and comparison to non-stressed material.
- Data Provenance: The data appears to be prospective, generated specifically for this 510(k) submission. The tests were conducted by Thermo DMA in their facilities (e.g., "samples of the calibrator material will be held for real time stability testing at Thermo DMA"). The text does not specify the country of origin beyond "Thermo DMA, Inc. 845 Avenue G East Arlington, Texas 76011".
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This submission is for a multi-analyte mixture calibrator, not an imaging or diagnostic device requiring human expert interpretation. Ground truth is established through chemical assays, NIST traceability, and comparison to established predicate device performance.
4. Adjudication Method for the Test Set
- Not Applicable. Since human interpretation or consensus is not involved in establishing the performance of a calibrator, there is no adjudication method in the traditional sense. The "adjudication" is based on instrumental measurements and comparison to defined reference values (NIST, predicate, vendor calibrators).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This is a calibrator for clinical chemistry assays, not a diagnostic device requiring human interpretation, so an MRMC study is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, implicitly. The studies described focus entirely on the performance of the calibrator itself, independent of human interpretation or "in-the-loop" assistance. The calibrator's performance is assessed through its interaction with clinical chemistry assay systems (e.g., Roche Hitachi 717) and its ability to provide accurate and traceable reference points for measurements.
7. Type of Ground Truth Used
- Expert Consensus, Pathology, Outcomes Data: None of these.
- Physicochemical and Traceable Standards: The ground truth for the analyte values is established through:
- NIST Primary Standards: Where available, assays were calibrated against NIST primary standards, and Primary Standards were produced in-house utilizing NIST Standard Reference Materials (SRM).
- High Purity Materials and Established Clinical Chemistry Procedures: Where NIST SRMs were not available, standards were prepared using high purity materials according to established analytical procedures with known performance characteristics.
- Comparison to Predicate Device and Vendor Calibrators: The performance was also validated by comparing results to those obtained with the predicate device and a recognized vendor's calibrator (Verichem).
8. Sample Size for the Training Set
- Not Applicable. This is a calibrator, not an AI/ML algorithm that requires a "training set" for model development. The product itself is the "reference material".
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set in the context of this device, this question is not relevant. The closest analogy would be how the assigned values for the calibrator were established, which is detailed in point 7 above.
Ask a specific question about this device
(49 days)
THERMO DMA, INC.
This reagent is intended for use with Thermo Trace Ammonia Reagent(510(k) number K(74620) to establish points of reference that are used in the determination of Ammonia in human plasma.
The Thermo Trace Ammonia Standards are aqueous (ammonia free deionized water) solutions of Ammonium Sulfate (Merck GR ACS (ammonia rece delonioa navis) preservative (Sodium Azide). The Thermo Trace Ammonia Standard set is intended for in vitro diagnostic use with Thermo Trace Ammonia Reagent (K974620) to establish points of reference that are used in the determination of Ammonia in human plasma.
This document describes the Thermo Trace Ammonia Standards Set, which is intended for in vitro diagnostic use with Thermo Trace Ammonia Reagent to establish points of reference for the determination of Ammonia in human plasma.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes the process for establishing and validating the values of the Thermo Trace Ammonia Standards Set rather than presenting explicit acceptance criteria with numerical performance targets and reported device performance against those targets. Instead, the "acceptance criteria" are implied by the methods used to ensure the quality and accuracy of the standards.
| Acceptance Criteria (Implied) | Reported Device Performance/Method of Verification |
|---|---|
| Purity/Composition | Specified amount of Anhydrous Ammonium Sulfate accurately weighed on a calibrated analytical balance and dissolved in Class A volumetric flask with ammonia-free deionized water ( |
Ask a specific question about this device
(64 days)
THERMO DMA, INC.
This reagent is intended for the in vitro quantitative determination of Alkaline Phosphatase in human serum and plasma. Measurements of Alkaline Phosphatase or its isoenzymes are used as in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases.
TRACE Scientifics' alkaline phosphatase reagents are intended for the in vitro quantitative determination of alkaline phosphatase in human serum and plasma. The TRACE ALP - AMP (IFCC) method is based on the recommendations of the International Federation of Clinical Chemistry (IFCC). This method utilizes 4-nitrophenylphosphate (4-NPP) as the substrate. Under the optimized conditions ALP present in the sample catalyses the following transphosphorylation reaction. At the pH of the reaction 4-NPP has an intense yellow color. The reagent also contains a metal ion buffer system to ensure that optimal concentrations of metal ions are maintained. The metal ion buffer can also chelate other potentially inhibitory ions, which may be present. The reaction is monitored by measuring the increase in absorbance at 405 nm, which is proportional to the activity of ALP in the serum.
This document describes the acceptance criteria and the study conducted to demonstrate that the TRACE Scientific Alkaline Phosphatase, Two-Part Liquid Assay meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Method Comparison | Strong correlation with predicate device (Roche Diagnostics Alkaline Phosphatase). | Correlation Coefficient: 0.9997 |
| Slope: 1.03 | ||
| Intercept: -0.33 | ||
| Mean (TRACE Scientific): 105 U/L | ||
| Mean (Roche): 100 U/L | ||
| Precision (Within Run) | Low variability (CV%) | Level 1: CV 0.9% |
| Level 2: CV 0.6% | ||
| Precision (Total) | Low variability (CV%) | Level 1: CV 3.5% |
| Level 2: CV 2.9% | ||
| Sensitivity | Adequate detection capability | 0.4 AmAbs/min per U/L |
| Reportable Range | Linear performance across clinically relevant range | Linear up to 2000 U/L |
| Specificity (Interference) | Minimal interference from common substances | Bilirubin (conjugated): No interference up to 16.3 mg/dL |
| Bilirubin (unconjugated): No interference up to 17.1 mg/dL | ||
| Hemoglobin: No interference up to 790 mg/dL | ||
| Lipemia: No interference up to 2000 mg/dL (measured as triglycerides, bichromatically) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Method Comparison): 60 sample pairs.
- Sample Size (Precision): 40 data points per level for both "Within Run" and "Total" precision.
- Data Provenance: Not explicitly stated, but implies human serum and plasma samples based on the intended use. The study was carried out by Thermo DMA, Inc., which is based in Arlington, TX, USA. It is a retrospective study since it involved already collected serum/plasma samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. This device is an in vitro diagnostic (IVD) assay for quantitative determination of a chemical marker (Alkaline Phosphatase) in biological samples, not an imaging or diagnostic AI requiring expert human interpretation for ground truth. The predicate device (Roche Diagnostics Alkaline Phosphatase) serves as the reference for comparative analysis.
4. Adjudication Method for the Test Set
- Not applicable. The study involves direct quantitative comparison of measurements between the TRACE Scientific device and a predicate device, not qualitative assessment requiring adjudication.
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 is more relevant for diagnostic imaging AI where human readers interpret cases. This document describes an in vitro diagnostic assay.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, this document primarily describes standalone performance of the TRACE Scientific Alkaline Phosphatase assay. The method comparison was done by directly comparing results from the TRACE Scientific device with those from the Roche Diagnostics Alkaline Phosphatase assay on an automated clinical chemistry analyzer (Hitachi 911), without human intervention in result generation for the comparison. The other studies (precision, sensitivity, linearity, specificity) also describe the standalone performance of the assay.
7. The Type of Ground Truth Used
- For the method comparison study, the "ground truth" was established by the predicate device measurement (Roche Diagnostics Alkaline Phosphatase assay), considered a legally marketed and accepted method for Alkaline Phosphatase determination.
- For other performance characteristics like linearity and specificity, the "ground truth" was established through controlled experiments using known concentrations of analytes or interfering substances.
8. The Sample Size for the Training Set
- Not applicable. This is an in vitro diagnostic assay based on a chemical reaction methodology (IFCC method), not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for this type of device.
Ask a specific question about this device
(59 days)
THERMO DMA, INC.
This reagent is intended for the in vitro quantitative determination of Fructosamine (glycated protein) in human serum when run on the Hitachi 704 automated chemistry analyzer. Measurements of fructosamine are used as an aid for short-term glycemic control related to diabetes management.
Thermo DMA's fructosamine reagent is intended for the in vitro quantitative determination of Fructosamine in human serum. Under alkaline conditions, analytes with Amadori rearrangements, such as Fructosamine, have reducing activity that can be differentiated from other reducing substances. In the presence of carbonate buffer, fructosamine rearranges to the eneaminol form, which reduces Nitroblue tetrazolium (NBT) to a formazan. The absorbance at 530 nm is measured at two time points and the absorbance change is proportional to the fructosamine concentration. A 10-minute incubation is employed to allow fast reacting interfering reducing substances to react. Removal of endogenous glucose is not required due to the fact that a pH of greater than 11 is required for glucose to reduce NBT.
Here's a breakdown of the acceptance criteria and study details for the Thermo DMA Fructosamine Assay, based on the provided text:
Thermo DMA Fructosamine Assay: Acceptance Criteria and Study Details
The provided document describes the Thermo DMA Fructosamine Assay, intended for the in vitro quantitative determination of Fructosamine in human serum. The study primarily focuses on demonstrating substantial equivalence to a predicate device (Sigma Diagnostics Fructosamine, Procedure No. 465) through method comparison and precision studies.
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in a dedicated section. Instead, it presents performance data and then concludes that the device is "safe and effective" and that "No significant differences exist between the results obtained on samples analyzed utilizing the Thermo DMA Fructosamine when compared to those obtained when utilizing the predicate device in these studies."
Based on the presented data, the implicit acceptance criteria and the device's reported performance are summarized below:
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Method Comparison | Strong correlation with the predicate device, with a slope close to 1, an intercept close to 0, and a high correlation coefficient. | Number of Sample Pairs: 49 |
| Range of Sample Results: 1.25 - 5.10 mmol/L | ||
| Mean (Sigma): 2.17 | ||
| Mean (Thermo DMA): 2.17 | ||
| Slope: 0.980 | ||
| Intercept: 0.039 | ||
| Correlation Coefficient: 0.998 | ||
| Precision (Within Run) | Low Coefficient of Variation (CV%) | Level 1: Mean = 2.21 mmol/L, SD = 0.02 mmol/L, CV = 1.1% (N=20) |
| Level 2: Mean = 3.47 mmol/L, SD = 0.04 mmol/L, CV = 1.1% (N=20) | ||
| Precision (Total Run) | Low Coefficient of Variation (CV%) | Level 1: Mean = 2.21 mmol/L, SD = 0.04 mmol/L, CV = 1.6% (N=10) |
| Level 2: Mean = 3.42 mmol/L, SD = 0.04 mmol/L, CV = 1.2% (N=10) | ||
| Sensitivity | Ability to detect low concentrations of fructosamine. | Instrument Resolution: 0.02 mmol/L (based on A = 0.001) |
| Serial Dilution: 0.1 mmol/L (based on control material) | ||
| Reportable Range | Ability to accurately measure fructosamine over a clinically relevant range, encompassing both normal and elevated levels. | Observed Range (asymptomatic samples): 1.6 - 2.6 mmol/L (N=31) |
| Linearity: Demonstrated acceptable performance up to 6.0 mmol/L | ||
| Specificity (Bilirubin) | Absence of significant interference at clinically relevant bilirubin levels. | At 2.5 mmol/L fructosamine: Positive interference > 2.8 mg/dL bilirubin. |
| At 4.1 mmol/L fructosamine: Positive interference > 13.5 mg/dL bilirubin. (Suggests interference at higher bilirubin levels, implying an implicit acceptance of lower levels/consideration for clinical context) | ||
| Specificity (Hemoglobin) | Absence of significant interference at clinically relevant hemoglobin levels. | "Hemolyzed samples are not recommended for use in this assay." |
| At 2.5 mmol/L fructosamine: Negative interference > 83 mg/dL hemoglobin. (Indicates the need to avoid hemolyzed samples, suggesting this is a limitation rather than direct "acceptance" for hemolyzed samples) | ||
| Specificity (Ascorbic Acid) | Absence of significant interference at clinically relevant ascorbic acid levels. | At 2.5 mmol/L fructosamine: Negative interference > 4 mg/dL ascorbic acid. |
| At 4.2 mmol/L fructosamine: Negative interference > 8 mg/dL ascorbic acid. (Suggests interference at higher ascorbic acid levels, implying an implicit acceptance of lower levels/consideration for clinical context) | ||
| Specificity (Lipemic Interference) | Absence of significant interference at clinically relevant triglyceride levels. | At 2.5 mmol/L fructosamine: Positive interference > 242 mg/dL triglycerides. (Suggests interference at higher triglyceride levels, implying an implicit acceptance of lower levels/consideration for clinical context) |
| Reference Ranges | Should align with established clinical reference ranges for non-diabetic and diabetic populations. | For 55 non-diabetic subjects: 1.9 - 2.9 mmol/L (95th percentile 2.7 mmol/L). |
| For diabetic subjects: 2.1 - 5.0 mmol/L (10% of values below 2.7 mmol/L). (These are presented as external reference ranges, not directly "acceptance criteria" but used to frame the device's utility in a clinical context.) |
2. Sample Size and Data Provenance
- Test Set (Method Comparison): 49 sample pairs.
- Data Provenance: Not explicitly stated, but the comparison describes using a "commercially available calibrator as a reference" and "Serum samples were assayed in parallel," suggesting prospective collection for the purpose of this comparison study. The country of origin is not specified, but the submission is from the USA.
- Test Set (Reportable Range/Observed Range): 31 human serum samples.
- Data Provenance: "asymptomatic with respect to fructosamine," suggesting these were normal, healthy individuals. Again, likely prospective for this study, country of origin not specified.
- Test Set (Precision):
- Within Run: 20 data points for Level 1, 20 for Level 2.
- Total: 10 samples for Level 1, 10 for Level 2.
- Data Provenance: Not specified, but generally, precision studies use controls or pooled patient samples run repeatedly, likely prospective.
3. Number of Experts and Qualifications for Ground Truth for Test Set
- Not Applicable. This is an in vitro diagnostic assay directly measuring a biochemical marker (fructosamine). The "ground truth" for the method comparison is the measurement obtained from the predicate device (Sigma Diagnostics Fructosamine). For sensitivity, precision, and linearity, the ground truth is derived from the known concentrations in control materials or the inherent properties of the measurement system. Expert consensus is not used to establish the "ground truth" for the quantitative values of fructosamine.
4. Adjudication Method for the Test Set
- Not Applicable. As this is a quantitative chemical assay, expert adjudication in the traditional sense (e.g., for image interpretation) is not relevant. The "adjudication" is the direct comparison of quantitative results from the candidate device to the predicate device, or to known values from controls.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is typically relevant for medical imaging or subjective interpretation tasks where multiple human readers assess cases. This document describes an in vitro diagnostic assay, where the "reader" is an automated clinical chemistry analyzer (Hitachi 704). Therefore, an MRMC study is not applicable.
6. Standalone Performance (Algorithm Only)
- Yes, implicitly. The entire study describes the standalone performance of the "Thermo DMA Fructosamine Assay" reagent when run on an automated analyzer. There is no human interpretation or intervention in the measurement process itself beyond loading samples and calibrators. The results presented (Method Comparison, Precision, Sensitivity, Reportable Range, Specificity) are all measures of the algorithm/reagent's performance in isolation from subjective human interpretation.
7. Type of Ground Truth Used
- Comparator Device Measurements: For the method comparison study, the ground truth was essentially the quantitative results obtained from the predicate device (Sigma Diagnostics Fructosamine).
- Known Concentrations/Control Material: For precision, sensitivity, and linearity, the "ground truth" was established by using control materials with known or expected fructosamine concentrations or by the inherent capability of the instrument to resolve small changes in absorbance.
- Clinical Observation: For the "Reportable Range" study, 31 "asymptomatic" human serum samples were used to establish an observed normal range, implying a form of clinical ground truth for typical healthy levels.
8. Sample Size for the Training Set
- The document does not mention a separate "training set". This type of assay (a chemical reagent kit) does not involve machine learning or AI models that typically require a distinct training set. The "training" for the assay would be the development and optimization of the chemical reactions and parameters by Thermo DMA, which precedes the validation studies described here.
9. How Ground Truth for Training Set was Established
- Not Applicable. As there is no explicitly mentioned "training set" in the context of machine learning, the concept of establishing ground truth for it is not relevant to this submission. The development of the assay's methodology (e.g., optimal pH, incubation times, reagent concentrations) would have involved internal R&D, likely using chemically defined standards and characterized patient samples to ensure the reaction proceeds as intended and produces accurate results, but this is distinct from a "training set" for an AI algorithm.
Ask a specific question about this device
Page 1 of 1