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510(k) Data Aggregation
(224 days)
ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM
The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative determination of constituents in blood and other fluids.
The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative determination of carbon dioxide concentration in serum using the ACE Axcel Clinical Chemistry System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Direct Bilirubin Reagent is intended for the quantitative determination of direct bilirubin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Total Bilirubin Reagent is intended for the quantitative determination of total bilirubin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Magnesium Reagent is intended for the quantitative determination of magnesium concentration in serum using the ACE Axcel Clinical Chemistry System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low serum levels of magnesium) and hypermagnesemia (abnormally high serum levels of magnesium). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Axcel Clinical Chemistry System consists of two major components, the chemistry instrument and an integrated Panel PC. The instrument accepts the physical patient samples, performs the appropriate optical or potentiometric measurements on those samples and communicates that data to an integral Panel PC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.
In the ACE Carbon Dioxide (CO2-LC) Reagent assay, serum carbon dioxide (in the form of bicarbonate) reacts with phosphoenolpyruvate in the presence of phosphoenolpyruvate carboxylase and magnesium to yield oxaloacetic acid and phosphate. In the presence of malate dehydrogenase, the reduced cofactor is oxidized by oxaloacetic acid. The reduced cofactor absorbs strongly at 408 nm whereas its oxidized form does not. The rate of decrease in absorbance, monitored bichromatically at 408 nm/692 nm, is proportional to the carbon dioxide content of the sample.
In the ACE Direct Bilirubin Reagent assay, sodium nitrite added to sulfanilic acid forms diazotized sulfanilic acid. Bilirubin glucuronide in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The increase in absorbance, measured bichromatically at 554 nm/692 nm, one minute after sample addition, is directly proportional to the direct bilirubin concentration.
In the ACE Total Bilirubin Reagent assay, sodium nitrite, when added to sulfanilic acid. forms diazotized sulfanilic acid. Bilirubin in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The inclusion of dimethyl sulfoxide (DMSO) in the reagent as an accelerator causes both direct and indirect bilirubin to react rapidly. The increase in absorbance, measured bichromatically at 554 nm/692 nm, is directly proportional to the total bilirubin concentration in the sample.
Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to produce a red complex which is measured bichromatically at 525 nm/692 nm. The intensity of color produced is directly proportional to the magnesium concentration in the sample. EGTA prevents calcium interference by preferential chelation of calcium present in the sample.
This document describes the performance of the ACE Carbon Dioxide (CO2-LC) Reagent, ACE Direct Bilirubin Reagent, ACE Total Bilirubin Reagent, and ACE Magnesium Reagent when used with the ACE Axcel Clinical Chemistry System. The study aims to demonstrate substantial equivalence to the predicate device, the Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K931786).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided in the document are implicitly established by demonstrating comparability to the predicate device. The performance data presented are the results obtained for the current device and reagents.
| Reagent | Metric | Acceptance Criteria (Implicit) | Reported Device Performance (ACE Axcel System) |
|---|---|---|---|
| ACE Carbon Dioxide (CO2-LC) Reagent | |||
| Precision - Within-run CV (22 days, 4 levels) | 1.6 - 8.7% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 1.6 - 8.7% |
| Precision - Total CV (22 days, 4 levels) | 4.3 - 12.2% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 4.3 - 12.2% |
| Precision - Within-run CV (5 days, 3 POL sites) | 1.0 - 2.6% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 1.0 - 2.6% |
| Precision - Total CV (5 days, 3 POL sites) | 1.8 - 5.7% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 1.8 - 5.7% |
| Accuracy - Correlation Coefficient (main study, n=120) | Not explicitly stated, but high correlation with predicate expected | 0.9758 | |
| Accuracy - Correlation Coefficient (POL studies, 3 sites) | Not explicitly stated, but high correlation with predicate expected | 0.9819 to 0.9952 | |
| Detection Limit | Not explicitly stated but expected to be clinically acceptable | 1.2 mEq/L | |
| ACE Direct Bilirubin Reagent | |||
| Precision - Within-run CV (22 days, 4 levels) | 0.8 - 16.5% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 0.8 - 16.5% |
| Precision - Total CV (22 days, 4 levels) | 1.5 - 16.6% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 1.5 - 16.6% |
| Precision - Within-run CV (5 days, 3 POL sites) | 0.0 - 4.6% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 0.0 - 4.6% |
| Precision - Total CV (5 days, 3 POL sites) | 0.0 - 4.6% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 0.0 - 4.6% |
| Accuracy - Correlation Coefficient (main study, n=116) | Not explicitly stated, but high correlation with predicate expected | 0.9996 | |
| Accuracy - Correlation Coefficient (POL studies, 3 sites) | Not explicitly stated, but high correlation with predicate expected | 0.9996 to 0.9997 | |
| Detection Limit | Not explicitly stated but expected to be clinically acceptable | 0.1 mg/dL | |
| ACE Total Bilirubin Reagent | |||
| Precision - Within-run CV (22 days, 4 levels) | 0.6 - 10.6% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 0.6 - 10.6% |
| Precision - Total CV (22 days, 4 levels) | 1.1 - 10.6% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 1.1 - 10.6% |
| Precision - Within-run CV (5 days, 3 POL sites) | 0.9 - 22.1% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 0.9 - 22.1% |
| Precision - Total CV (5 days, 3 POL sites) | 0.0 - 3.3% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 0.0 - 3.3% |
| Accuracy - Correlation Coefficient (main study, n=117) | Not explicitly stated, but high correlation with predicate expected | 0.9997 | |
| Accuracy - Correlation Coefficient (POL studies, 3 sites) | Not explicitly stated, but high correlation with predicate expected | 0.9993 to 1.0000 | |
| Detection Limit | Not explicitly stated but expected to be clinically acceptable | 0.2 mg/dL | |
| ACE Magnesium Reagent | |||
| Precision - Within-run CV (22 days, 4 levels) | 2.7 - 5.9% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 2.7 - 5.9% |
| Precision - Total CV (22 days, 4 levels) | 4.1 - 7.6% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 4.1 - 7.6% |
| Precision - Within-run CV (5 days, 3 POL sites) | 1.2 - 4.1% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 1.2 - 4.1% |
| Precision - Total CV (5 days, 3 POL sites) | 2.0 - 6.9% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 2.0 - 6.9% |
| Accuracy - Correlation Coefficient (main study, n=108) | Not explicitly stated, but high correlation with predicate expected | 0.9690 | |
| Accuracy - Correlation Coefficient (POL studies, 3 sites) | Not explicitly stated, but high correlation with predicate expected | 0.9858 to 0.9930 | |
| Detection Limit | Not explicitly stated but expected to be clinically acceptable | 0.2 mg/dL |
The study demonstrates that the ACE Axcel Clinical Chemistry System with the listed reagents achieves precision and accuracy comparable to the predicate device, supporting substantial equivalence.
2. Sample sizes used for the test set and the data provenance
The studies conducted are primarily accuracy (correlation) and precision studies.
- ACE Carbon Dioxide (CO2-LC) Reagent:
- Accuracy (correlation study): 120 samples.
- Accuracy (patient correlation studies): Conducted at three separate Physician Office Laboratory (POL) sites; the number of samples per POL site is not specified, but the total across all sites for CO2 values ranged from 3.2 to 47.6 mEq/L.
- Precision: Four CO2 levels tested for 22 days; three separate POL sites tested for 5 days.
- ACE Direct Bilirubin Reagent:
- Accuracy (correlation study): 116 samples.
- Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Direct Bilirubin values ranged from 0.2 to 12.5 mg/dL.
- Precision: Four direct bilirubin levels tested for 22 days; three separate POL sites tested for 5 days.
- ACE Total Bilirubin Reagent:
- Accuracy (correlation study): 117 samples.
- Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Total Bilirubin values ranged from 0.2 to 34.8 mg/dL.
- Precision: Four total bilirubin levels tested for 22 days; three separate POL sites tested for 5 days.
- ACE Magnesium Reagent:
- Accuracy (correlation study): 108 samples.
- Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Magnesium values ranged from 0.6 to 5.5 mg/dL.
- Precision: Four magnesium levels tested for 22 days; three separate POL sites tested for 5 days.
Data Provenance: The document does not explicitly state the country of origin for the data. The "POL sites" (Physician Office Laboratory sites) suggest these are real-world clinical samples, likely from within the United States given the 510(k) submission. The data appears to be prospective in nature, as indicated by the description of testing conducted over 22 days and 5 days at different sites for precision and the collection of samples for correlation studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is a clinical chemistry device for quantitative determination. The ground truth is established by comparing the device's measurements against a predicate device (Alfa Wassermann ACE Clinical Chemistry System). Therefore, no human experts are explicitly mentioned as establishing a "ground truth" in the diagnostic interpretation sense. The predicate device itself serves as the reference standard.
4. Adjudication method for the test set
Not applicable. This study involves quantitative measurements by a device and comparison to a predicate device, not qualitative interpretations requiring human adjudication.
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 clinical chemistry analyzer and reagent system, not an AI-assisted diagnostic imaging or interpretation system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance data presented are for the standalone algorithm/device (ACE Axcel Clinical Chemistry System with the specified reagents) measuring analytes in samples, compared directly against a predicate device. There is no human-in-the-loop component mentioned in the context of the reported performance data.
7. The type of ground truth used
The type of ground truth used is comparison to a legally marketed predicate device. The ACE Axcel Clinical Chemistry System and its reagents were compared to the Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K931786). The predicate device's measurements serve as the reference for established accuracy.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that typically involves a distinct "training set." The device's performance is based on established chemical reactions and detection methods. The studies described are for validation/testing of the device's performance against a predicate, not for training an algorithm.
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.
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(199 days)
OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181
System reagent for the quantitative determination of Direct Bilirubin in human serum on OLYMPUS analyzers.
Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
For in vitro diagnostic use.
The Olympus Direct Bilirubin Reagent (OSR6X181) is a system reagent.
The provided text is a 510(k) premarket notification acceptance letter from the FDA for a medical device called "The Olympus Direct Bilirubin Reagent (OSR6X181)". This type of document confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
However, this document does not contain the detailed study information, acceptance criteria, or performance data that would allow me to fill out the requested table and answer the specific questions about device performance and validation studies.
The letter focuses on regulatory approval based on substantial equivalence, rather than providing the performance data from the studies that supported that equivalence. To answer your questions, I would need access to the actual 510(k) submission, which typically includes the detailed study reports.
Therefore, I cannot provide the requested information based on the input text.
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(8 days)
VITALAB DIRECT BILIRUBIN REAGENT
The Vitalab Direct Bilirubin Reagent is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of conjugated (direct) bilirubin in serum and plasma. Direct bilirubin results may be used for the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block.
The Vitalab Total Bilirubin Reagent is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of total bilirubin in serum and plasma. Total bilirubin results may be used for the diagnosis and treatment af liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
The Vitalab Bilirubin Calibrator is intended to calibrate the Vitalab Selectra Analyzer for the quantitative determination of total and direct bilirubin in serum and plasma.
The Vitalab Direct Bilirubin Reagent is a two-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines conjugated bilirubin through a reaction with diazotized 2,4-dichloroanaline to produce a colored chromogen in acidic solution.
The Vitalab Total Bilirubin Reagent is a two-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines total bilirubin through a reaction with diazotized 2,4-dichloroanaline in the presence of detergents to produce a colored chromogen in acidic solution.
The Vitalab Bilirubin Calibrator is a liquid stable bilirubin calibrator prepared from purified components in a human serum albumin matrix. Bilirubin set points are traceable to NIST reference materials.
Below is a summary of the acceptance criteria and performance study details for the Vitalab Direct Bilirubin Reagent, Vitalab Total Bilirubin Reagent, and Vitalab Bilirubin Calibrator, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Vitalab Direct Bilirubin Reagent Acceptance Criteria / Predicate Performance (Implicit) | Vitalab Direct Bilirubin Reagent Reported Performance | Vitalab Total Bilirubin Reagent Acceptance Criteria / Predicate Performance (Implicit) | Vitalab Total Bilirubin Reagent Reported Performance |
|---|---|---|---|---|
| Linearity/Usable Range | Sufficiently linear to meet clinical needs (implicit, typically based on predicate). | Linear to at least 10.0 mg/dL. | Sufficiently linear to meet clinical needs (implicit, typically based on predicate). | Linear to at least 25.0 mg/dL. |
| Detection Limit | Low enough for clinical utility (implicit). | 0.0 mg/dL. | Low enough for clinical utility (implicit). | 0.0 mg/dL. |
| Precision | Acceptable within-run and total precision for clinical use (implicit, often referenced to NCCLS guidelines). | Serum 1 (0.3 mg/dL): Within Run 1SD = 0.03, %CV = 11.3%; Total 1SD = 0.03, %CV = 11.4%. | ||
| Serum 2 (1.7 mg/dL): Within Run 1SD = 0.02, %CV = 1.3%; Total 1SD = 0.05, %CV = 2.8%. | ||||
| Serum 3 (4.0 mg/dL): Within Run 1SD = 0.02, %CV = 0.5%; Total 1SD = 0.10, %CV = 2.6%. | Acceptable within-run and total precision for clinical use (implicit, often referenced to NCCLS guidelines). | Serum 1 (0.4 mg/dL): Within Run 1SD = 0.02, %CV = 5.8%; Total 1SD = 0.03, %CV = 6.7%. | ||
| Serum 2 (1.4 mg/dL): Within Run 1SD = 0.04, %CV = 3.1%; Total 1SD = 0.07, %CV = 4.8%. | ||||
| Serum 3 (5.8 mg/dL): Within Run 1SD = 0.07, %CV = 1.1%; Total 1SD = 0.15, %CV = 2.5%. | ||||
| Correlation/Method Comparison | Substantially equivalent to predicate device (implicit standard for 510(k)). | Selectra = 0.05 mg/dL + 0.832 x Competitive Reagent (r=0.9995, syx = 0.12 mg/dL if we assume the r and syx from linearity applies to correlation, which is probably incorrect, but no other value given for correlation specific r, syx). Range = 0.1 - 11.6 mg/dL. syx = 0.14 mg/dL (from calibration section, which seems to refer back to this data). | Substantially equivalent to predicate device (implicit standard for 510(k)). | Selectra = -0.4 mg/dL + 1.037 x Competitive Reagent. Range = 0.1 - 25.9 mg/dL. syx = 0.20 mg/dL. |
| Stability (Onboard Reagent & Calibration) | Meet claimed stability (implicit). | 14 day onboard reagent stability and 7 day calibration stability met (total imprecision |
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(270 days)
ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR
The ATAC Direct Bilirubin Reagent Kit, which contains both reagent and calibrator, is intended for use with the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of conjugated bilirubin in serum and plasma. Conjugated bilirubin results are used for the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
The ATAC Direct Bilirubin Reagent Kit, which contains both reagent and calibrator, is substantially equivalent to the Trace Direct Bilirubin Reagent, product UG38 (Trace Scientific, Ltd. of Melbourne, Australia) calibrated with the Sigma Bilirubin Calibrator, Total and Direct, product no. B8652 (Sigma Diagnostics, Inc. St. Louis, MO). The effectiveness of ATAC Direct Bilirubin Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown in the following studies.
The ATAC Direct Bilirubin Reagent determines conjugated bilirubin through its reaction with diazotized sulfanilic acid to form a red-purple complex. The resulting increase in absorbance at 546 nm is proportional to the direct bilirubin concentration in the sample.
This document describes the acceptance criteria and performance of the ATAC Direct Bilirubin Reagent Kit, a device intended for the quantitative determination of conjugated bilirubin in serum and plasma.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in the provided text. However, the reported device performance demonstrates the device's characteristics, which would implicitly meet internal acceptance based on established analytical standards for diagnostic reagents. We can infer the "acceptance" by the fact that these results are presented as evidence of the device's effectiveness and substantial equivalence.
| Acceptance Criteria (Inferred from reported performance) | Reported Device Performance (ATAC Direct Bilirubin Reagent Kit) |
|---|---|
| Linearity Range | Linear from 0.1 to 20 mg/dL |
| Linearity Regression (Correlation Coefficient) | r = 0.999 |
| Linearity Regression (Sy.x) | 0.29 mg/dL |
| Within Run Precision (Serum 1, 0.9 mg/dL) | 0.10 1SD, 10.3% CV |
| Within Run Precision (Serum 2, 3.8 mg/dL) | 0.11 1SD, 3.0% CV |
| Within Run Precision (Serum 3, 6.7 mg/dL) | 0.12 1SD, 1.9% CV |
| Total Precision (Serum 1, 0.9 mg/dL) | 0.09 1SD, 9.2% CV |
| Total Precision (Serum 2, 3.8 mg/dL) | 0.13 1SD, 3.4% CV |
| Total Precision (Serum 3, 6.7 mg/dL) | 0.18 1SD, 2.7% CV |
| Method Comparison (Deming Regression Slope) | 1.143 |
| Method Comparison (Deming Regression Intercept) | -0.10 mg/dL |
| Method Comparison (Sy.x) | 0.32 mg/dL |
| Detection Limit | 0.1 mg/dL |
| Onboard Reagent/Calibration Stability (Imprecision) | Less than 0.15 mg/dL or 3% over 5 days |
| Reconstituted Stability (Shift) | Less than 0.1 mg/dL or 6% over 14 days |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Linearity: n = 18 (for standard factor recoveries).
- Sample Size for Precision: n = 60 for each of the three control serum levels (total 180 assays)
- Sample Size for Method Comparison: n = 96 (after exclusions).
- Sample Size for Detection Limit: 125 results over 25 runs.
- Data Provenance: The document states that mixed serum and plasma specimens were collected from adult patients. The country of origin is not explicitly stated, but the predicate device is from Trace Scientific, Ltd. of Melbourne, Australia, and Sigma Diagnostics, Inc. St. Louis, MO, for the calibrator, suggesting a US/Australian context. The study appears to be prospective in nature, as indicated by the collection of patient specimens for the method comparison and repeated assays for precision and detection limit.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This device is an in vitro diagnostic reagent kit for quantitative determination of a biomarker (conjugated bilirubin). The "ground truth" for such devices is typically established through reference methods or highly accurate analytical techniques, not through expert human interpretation of images or clinical cases. Therefore:
- Number of Experts: Not applicable in the context of this type of diagnostic device.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving subjective interpretations (e.g., imaging studies where multiple readers interpret results and discrepancies need to be resolved). For a quantitative chemical assay, the "adjudication" is inherent in the analytical methodology itself, such as repeat measurements, statistical analysis, and comparison to a predicate device or reference method.
- Adjudication Method: Not applicable in the traditional sense. The method comparison study involved comparing the ATAC 8000 results with those from another commercially available method, and statistical analysis (Deming regression) was used to assess agreement. Outliers were excluded based on statistical criteria (poor reproducibility and residuals exceeding 6 standard errors).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study is relevant for devices involving human interpretation of results, such as imaging diagnostics. This is a quantitative chemical assay that provides a numerical output.
- Effect size of human readers improve with AI vs without AI assistance: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Yes, the entire evaluation presented (linearity, precision, method comparison, detection limit, stability) represents the standalone performance of the ATAC Direct Bilirubin Reagent Kit on the ATAC 8000 Random Access Chemistry System. This is an automated system; once the sample is loaded, the measurement is performed by the instrument and reagents without real-time human intervention in the result generation process.
7. The Type of Ground Truth Used
- Ground Truth Type:
- Reference Standards: For linearity, the ground truth was established by "standard values" which are specific concentrations of conjugated bilirubin used for calibration curves.
- Commercially Available Control Serum: For precision, the ground truth was the expected range of values for these control sera.
- Comparison to a Predicate Device/Method: For method comparison, the ground truth was established by "another commercially available method" (the "Competitive Reagent"). This approach demonstrates substantial equivalence, where the predicate serves as the de facto "ground truth" for comparative performance.
- Diluted Serum Pool: For the detection limit, the ground truth involved a diluted serum pool to assess the lowest measurable concentration.
8. The Sample Size for the Training Set
This document describes the validation of a chemical reagent kit, not a machine learning or AI-based algorithm that typically uses "training sets." The linearity standards, control sera, and patient samples used in the performance studies are for validation/testing, not for "training" the reagent itself.
- Sample Size for the Training Set: Not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of this device, this question is not applicable. The device's operational parameters (e.g., absorbance at 546 nm proportional to concentration) are based on established chemical principles, not on a trained algorithm.
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(63 days)
DIRECT BILIRUBIN REAGENT
This device is intended for the quantitative determination of direct bilirubin in serum or plasma. Bilirubin is an organic compound formed during the catabolism of red blood cells and its measurement is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a "Direct Bilirubin Reagent." This document is an approval letter for a medical device and does not contain information about acceptance criteria, study details, or performance metrics.
Therefore, I cannot extract the requested information from the provided input. The document confirms that the device is "substantially equivalent" to legally marketed devices, but does not present the specific data from a study to demonstrate this.
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(44 days)
SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT
The Synermed® Direct Billirubin reagent is intended for use in the quantitative determination of conjugated (direct reacting) bilirubin in serum or plasma.
Direct Bilirubin Reagent Kit
This document is a 510(k) clearance letter for the Synermed® IR750 Direct Bilirubin Reagent. It is not a study report or a detailed description of the device's performance characteristics. Therefore, much of the requested information regarding acceptance criteria and a study proving those criteria are met is not present in the provided text.
Based on the provided text, I can extract the following limited information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not contain a table of acceptance criteria or reported device performance for the Synermed® IR750 Direct Bilirubin Reagent. The FDA letter states that the device is "substantially equivalent" to legally marketed predicate devices, which implies that its performance is expected to be comparable, but no specific performance metrics or acceptance criteria are detailed here.
Regarding the other points, the document provides insufficient information to answer most of them:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available. The document gives no details about any specific test set used, its size, or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not available. This is a reagent for quantitative determination, not an imaging device requiring expert interpretation for ground truth. No information on experts establishing ground truth is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not available. This is a reagent for quantitative determination. Adjudication methods are typically relevant for interpretive tasks (e.g., radiology reads), not for the performance validation of a chemical reagent.
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 document describes a chemical reagent, not an AI-assisted diagnostic tool or an imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a chemical reagent. Its performance would be evaluated as a standalone assay, not an algorithm. The document doesn't provide details of such an evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not available. Given this is a quantitative determination of a biomarker, "ground truth" would typically refer to a reference method or a highly accurate "gold standard" measurement of direct bilirubin. However, the document does not specify the method used to establish this.
8. The sample size for the training set:
- Not applicable/Not available. This is a chemical reagent. Training sets are typically associated with machine learning algorithms. While method development involves optimization, it's not referred to as a "training set" in this context.
9. How the ground truth for the training set was established:
- Not applicable/Not available. (See point 8).
Summary of available information from the document:
- Device Name: Synermed® IR750 Direct Bilirubin Reagent
- Intended Use: Quantitative determination of conjugated (direct reacting) bilirubin in serum or plasma.
- Regulatory Status: Cleared under 510(k) as substantially equivalent to legally marketed predicate devices.
- Regulatory Class: II
- Product Code: CIG
To obtain the detailed information requested, one would need to review the actual 510(k) submission document (if publicly available) or the internal validation studies performed by Synermed Inc. This FDA clearance letter primarily confirms the substantial equivalence determination.
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(39 days)
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844
The Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin reagent is intended for use for the quantitative determination of direct bilirubin in serum and plasma of adults and neonates. It is for use on automated clinical chemistry analyzers.
According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1110, a bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.
Direct bilirubin, in the absence of a suitable solubilizing agent, is coupled with a diazonium ion in a strongly acid medium (pH 1 - 2).
Bilirubin + diazonium ion acid -> Azobilirubin
The intensity of the color of the azobilirubin formed is proportional to the direct bilirubin concentration and can be measured photometrically.
The provided 510(k) summary for the Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin Reagent does not explicitly state acceptance criteria or a detailed study proving the device meets specific performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
However, based on the information provided, we can infer the strategy for demonstrating equivalence and what would constitute "acceptance" in this context. The core of the submission is showing that the new device performs similarly to the predicate device, especially for its intended use.
Here's an analysis based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission implicitly states that the acceptance criterion is "substantial equivalence" to the predicate device, particularly regarding performance characteristics. While no numerical acceptance targets are listed, the document implies that the new device's performance is acceptable if it is comparable to the predicate.
| Feature Area | Acceptance Criterion (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Intended Use | Same as predicate (quantitative determination of direct bilirubin in serum/plasma of adults/neonates on automated analyzers). | The new device has the same intended use. |
| Sample Type | Same as predicate (serum or plasma, no preparation). | The new device uses serum or plasma, no preparation. |
| Analytical Principle | Same as predicate (Diazo reaction with azobilirubin product, measured spectrophotometrically). | The new device uses the same Diazo reaction and spectrophotometric measurement. |
| Calibration | Similar to predicate (uses commercially available calibrators with assigned values). | The new device uses commercially available calibrators with assigned values for direct bilirubin. |
| Accuracy / Correlation | Performance "substantially equivalent" to predicate device. | Not explicitly quantified in this summary, but the submission claims substantial equivalence through comparison to the predicate's performance. The original submission (Section V) would likely contain the specific performance data backing this claim. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given 510(k) summary. The summary refers to "Specific data on the performance of the system have been incorporated into the draft labeling in Section V of this submission." This section would contain details about the actual study: sample sizes (e.g., number of patient samples tested), and likely whether it was retrospective or prospective, and general location of data collection (e.g., in-house lab, clinical sites).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable in the context of this in vitro diagnostic (IVD) device. For IVD reagents like the direct bilirubin test, the "ground truth" is typically established by comparing results to a recognized reference method or another already validated, legally marketed device (the predicate). There wouldn't be "experts" establishing ground truth in the way a radiologist reads images.
4. Adjudication Method for the Test Set
This is not applicable for this type of IVD device. Adjudication methods (like 2+1, 3+1) are typically used in clinical trials, especially for imaging devices, where human readers consensus is required for ground truth. For an IVD, the comparison is typically against quantitative analytical results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size (Human Improvement with AI vs. Without AI)
This is not applicable. This submission is for an in vitro diagnostic reagent, not an AI-powered device or an imaging device that involves human readers interpreting results.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable as it's an IVD reagent, not an AI algorithm. The device itself is the "standalone" entity that produces a quantitative result.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance would be established by:
- Comparison to a legally marketed predicate device: The submission explicitly states "substantially equivalent to the currently marketed Roche Diagnostics, Boehringer Mannheim Direct Bilirubin reagent system". Performance studies would involve running patient samples on both the new device and the predicate device and showing acceptable correlation and agreement.
- Reference Methods: In some cases, established reference methods for bilirubin measurement might be used, but the primary method for demonstrating equivalence in a 510(k) is usually comparison to the predicate.
8. The Sample Size for the Training Set
This is not applicable in the context of this device. "Training set" refers to data used to train machine learning models. This is a chemical reagent, not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" for this type of device.
Summary of the Study (Inferred from the Document):
The study performed to demonstrate substantial equivalence for the Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin Reagent would have involved running a series of patient samples on both the new liquid reagent system and the predicate solid reagent system (Roche Diagnostics, Boehringer Mannheim Direct Bilirubin reagent system, catalog number 704027). The "acceptance criteria" were implicitly that the performance (e.g., accuracy, precision, linearity, interference) of the new reagent was comparable to, or within acceptable limits of variation from, the predicate device.
The specific data details (sample size, statistical analysis, actual performance numbers) are referenced as being in "Section V of this submission" and are not included in the provided 510(k) summary excerpt. The focus of the provided text is on outlining the similarities and minor differences (like reagent stability and preparation) between the new and predicate devices, and asserting that the performance characteristics are substantially equivalent.
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(37 days)
SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT
The Synermed® Direct Billirubin reagent is intended for use in the quantitative determination of conjugated (direct reacting) bilirubin in serum or plasma.
Not Found
I apologize, but the provided text from the FDA 510(k) letter for the Synermed IR750 Direct Bilirubin Reagent does not contain the requested information about acceptance criteria or a study proving the device meets them.
The document is purely an FDA clearance letter, confirming that the device is substantially equivalent to a predicate device and can be marketed. It does not detail the specific performance studies, their methodology, or the results that led to this clearance.
Therefore, I cannot provide the detailed table and study description you requested based on the given input.
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(78 days)
SYNERMED DIRECT BILIRUBIN REAGENT KIT
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