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510(k) Data Aggregation
(88 days)
Chaska, Minnesota 55318
Re: K231832
Trade/Device Name: Access Myoglobin Regulation Number: 21 CFR 866.5680
952) 465-1914
Trade Name: Access Myoglobin Common Name: Myoqlobin Classification Regulation: 21 CFR 866.5680
The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis of heart or renal disease.
The Access Myoglobin assay is a sandwich immunoenzymatic assay. The Access Myoglobin assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access Myoglobin assay reagent pack, Access Myoglobin assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
The provided text describes the Beckman Coulter Access Myoglobin assay, which is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma. The K231832 submission seeks to demonstrate substantial equivalence to the predicate device (Access Myoglobin assay, K021229) when run on the Dxl 9000 Access Immunoassay Analyzer.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a separate section with pass/fail thresholds for all performance metrics. However, it presents the results of various performance studies against industry guidelines (CLSI standards), which implicitly serve as the acceptance criteria for demonstrating appropriate performance.
| Performance Characteristic | Acceptance Criteria (Implicit from CLSI guidelines and typical assay requirements) | Reported Device Performance (Access Myoglobin on Dxl 9000) |
|---|---|---|
| Method Comparison (vs. Predicate) | Slope near 1.0, Intercept near 0, High correlation (R) | Slope: 0.99, Intercept: 0.47, R: 1.00 |
| Imprecision | ≤ 1.10 ng/mL SD at concentrations ≤ 11.0 ng/mL; ≤ 10.0% CV at concentrations > 11.0 ng/mL | Repeatability (Within-Run): 2.0-2.3% CV, 0.18 SD (low) |
| Between-Run: 2.2-4.0% CV, 0.18-85.9 SD | ||
| Between-Day: 0.0-3.0% CV, 0.0-3.0 SD | ||
| Within-Laboratory: 3.7-5.4% CV, 0.31-101.9 SD | ||
| Linearity | Demonstrate linearity across the measuring interval (e.g., polynomial fit not significantly better than linear) | Demonstrated linearity across the measuring interval |
| Limit of Blank (LoB) | Establish a LoB that is analytically sound | 3.0 ng/mL (μg/L) |
| Limit of Detection (LoD) | Establish a LoD that is analytically sound | 3.0 ng/mL (μg/L) |
| Limit of Quantitation (LoQ) | Establish a LoQ with acceptable imprecision (e.g., ≤ 20% within-lab CV) | 3.0 ng/mL (μg/L) at ≤ 20% within-lab CV |
2. Sample Sizes Used for the Test Set and Data Provenance
- Method Comparison: N = 155 (This refers to 155 patient samples). The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.
- Imprecision: N = 80 per sample assessed (e.g., Sample 1, Sample 2, etc.), which involved multiple samples tested in duplicate in 2 runs per day for a minimum of 20 days.
- Linearity: Sample size not explicitly stated, but typically involves a series of diluted/spiked samples.
- LoB, LoD, LoQ: Not explicitly stated as a single "sample size" but involved multiple reagent lots and 3 instruments over a minimum of 3-5 days.
The data provenance for all studies (country of origin, retrospective or prospective) is not specified in the provided document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The Access Myoglobin assay is an in vitro diagnostic device for quantitative measurement of a biomarker. Its "ground truth" is established through analytical performance studies, not typically by expert review of individual cases as would be done for imaging or clinical decision support AI. Therefore, this section is not applicable in the traditional sense for this type of device. The "truth" is based on the accurate measurement of myoglobin concentration.
4. Adjudication Method for the Test Set
As this is an in vitro diagnostic quantitative assay, there is no adjudication method described or necessary in the context of expert consensus, as might be found for imaging AI. The performance is assessed against reference methods or calibrated controls.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size
No MRMC comparative effectiveness study was done. This type of study is relevant for imaging or clinical decision support AI where human readers interpret results, and the AI might augment their performance. For a quantitative immunoassay, the "reader" is effectively the instrument, and the performance is evaluated on its analytical accuracy and precision.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented (Method Comparison, Imprecision, Linearity, LoB/LoD/LoQ) demonstrate the standalone performance of the Access Myoglobin assay on the Dxl 9000 Access Immunoassay Analyzer. These are analytical performance studies of the device itself, without human interpretation as a primary variable.
7. The Type of Ground Truth Used
The ground truth for these analytical performance studies is based on:
- Reference measurements: For method comparison, the predicate device (Access 2 Immunoassay System) served as the reference standard.
- Established concentrations/materials: For imprecision, linearity, LoB/LoD/LoQ, the ground truth is based on known concentrations of myoglobin in controls, calibrators, and spiked samples, prepared according to industry standards.
- Analytical principles: The assay measures myoglobin concentration, and the "ground truth" is the actual quantity of myoglobin present in a sample, determined through scientifically validated methods.
8. The Sample Size for the Training Set
This information is not provided in the document. For an immunoassay like this, there isn't a "training set" in the machine learning sense. The device's operational parameters and assay design are developed through extensive research and development, but this is distinct from an AI training dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit "training set" in the AI sense for this immunoassay submission, this question is not directly applicable. The "ground truth" during the development and optimization of such an assay would involve internal analytical studies using characterized materials and reference methods to ensure the assay accurately measures myoglobin concentrations.
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(286 days)
|
| Regulation Section: | 21 CFR 866.5680
The CKMB Test is an in vitro diagnostic assay for the quantitative determination of creatine kinase isoform MB in EDTA or lithium heparin whole-blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the diagnosis of myocardial infarction.
The Myo Test is an in vitro diagnostic assay for the quantitative determination of myoglobin in EDTA or lithium heparin whole-blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the rapid diagnosis of heart disease, for example, acute myocardial infarction.
For in vitro diagnostic use. The AQT90 FLEX analyzer is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point-of-care and laboratory settings.
The AQT90 FLEX is a cartridge-based immunoassay analyzer, based on time-resolved fluorescence using a europium (Eu) chelate as the fluorescent label. The test receptacles for the assay are test cups, which contain the antibodies used for capture of the analyte, and the Eu chelate labeled antibodies used to trace the captured analyte. The sample is added to the test cup together with assay buffer. The cup is then incubated to allow formation of the immuno-complex, and subsequently washed to remove unbound antibodies and sample material. Finally, the cup is exposed to excitation light, and after a delay the emitted light generated by the fluorescent label is measured by single photon counting. The total count is then compared to an assay calibration curve to obtain a quantitative measurement of the analyte's concentration in the sample.
This technology uses dried reagents deposited in the test cups and in the calibration adjustment cups – no liquids other than the sample itself together with the assay buffer are required.
The provided document is a 510(k) premarket notification from Radiometer Medical ApS for their AQT90 FLEX CKMB Test Kit, AQT90 FLEX Myo Test Kit, and the AQT90 FLEX analyzer. The submission is to seek clearance for modifications to the existing AQT90 FLEX system devices.
The document does not describe a study involving an AI model or a human-in-the-loop performance study. Instead, it describes analytical performance studies of in-vitro diagnostic assays (Myoglobin and CKMB) on a laboratory analyzer. Therefore, many of the requested elements pertaining to AI models, human experts, ground truth adjudication, MRMC studies, and training datasets are not applicable to this document.
However, I can extract information related to the acceptance criteria (implicitly, the performance metrics evaluated) and the studies conducted to prove the device meets these criteria in the context of an in-vitro diagnostic device.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria (Performance Metrics) and Reported Device Performance
For an in-vitro diagnostic device, acceptance criteria are typically related to analytical performance characteristics such as linearity, limits of detection/quantitation, method comparison (agreement with a predicate), and precision. The reported device performance is the outcome of the studies conducted for these characteristics.
AQT90 FLEX Myo Test Kit
| Performance Metric (Implicit Acceptance Criteria) | Reported Device Performance |
|---|---|
| Linearity (within 10% non-linearity) | Whole Blood & Plasma: Linear within the reportable range (20 – 900 ng/mL), with non-linearity within 10%. |
| Limit of Blank (LoB) | Myo: 0.5 ng/mL (µg/L) |
| Limit of Detection (LoD) | Myo: 1 ng/mL (µg/L) |
| Limit of Quantitation (LoQ) (at 10% CVWithin-lab) | Myo: 1 ng/mL (µg/L) |
| Method Comparison (vs. predicate) | |
| (Implicitly, good correlation and minimal bias) | Plasma: y = 1.01 x - 0.14 (n=103; r²=1.0) compared to predicate. |
| Matrix Comparison | |
| (Implicitly, interchangeability of matrix types) | Equivalence confirmed: No significant matrix effect differences between whole blood vs. plasma or lithium heparin vs. EDTA. (Regression equations provided for various comparisons, all showing strong correlation (r²=1.0) and slopes close to 1). |
| Precision (Repeatability, Between-Run, Total CVs) | Myo Whole Blood: |
| L1 (57 ng/mL): Total CV 2.3% | |
| L2 (92 ng/mL): Total CV 3.0% | |
| L3 (622 ng/mL): Total CV 2.4% | |
| Myo Plasma: | |
| L1 (53 ng/mL): Total CV 2.1% | |
| L2 (95 ng/mL): Total CV 2.2% | |
| L3 (586 ng/mL): Total CV 2.2% |
AQT90 FLEX CKMB Test Kit
| Performance Metric (Implicit Acceptance Criteria) | Reported Device Performance |
|---|---|
| Linearity (within 10% non-linearity) | Whole Blood & Plasma: Linear within the reportable range (1.5 – 300 ng/mL), with non-linearity within 10%. |
| Limit of Blank (LoB) | CKMB: 0.5 ng/mL (µg/L) |
| Limit of Detection (LoD) | CKMB: 1 ng/mL (µg/L) |
| Limit of Quantitation (LoQ) (at 20% CVWithin-lab) | CKMB: 1 ng/mL (µg/L) |
| Method Comparison (vs. predicate) | |
| (Implicitly, good correlation and minimal bias) | Plasma: y = 0.99 x - 0.18 (n=107; r²=1.0) compared to predicate. |
| Matrix Comparison | |
| (Implicitly, interchangeability of matrix types) | Equivalence confirmed: No significant matrix effect differences between whole blood vs. plasma or lithium heparin vs. EDTA. (Regression equations provided for various comparisons, all showing strong correlation (r²=1.0) and slopes close to 1). |
| Precision (Repeatability, Between-Run, Total CVs) | CKMB Whole Blood: |
| L1 (2.6 ng/mL): Total CV 4.8% | |
| L2 (14 ng/mL): Total CV 4.9% | |
| L3 (204 ng/mL): Total CV 3.4% | |
| CKMB Plasma: | |
| L1 (2.3 ng/mL): Total CV 3.7% | |
| L2 (8.4 ng/mL): Total CV 2.8% | |
| L3 (209 ng/mL): Total CV 2.2% |
2. Sample Size Used for the Test Set and Data Provenance
- Linearity (Myo & CKMB): 11 sample levels for linearity series, measured with 10 replicates each. This is an in vitro analytical study, not patient data.
- LoB/LoD/LoQ (Myo & CKMB):
- LoB: Four blank samples measured with 5 replicates on 3 days, using 2 test kit lots and 2 analyzers. Total 60 measurements per test kit lot.
- LoD/LoQ: 10 samples per matrix (lithium heparin whole blood and plasma).
- Method Comparison (Myo & CKMB):
- Myo: n=103 lithium heparin plasma samples.
- CKMB: n=107 lithium heparin plasma samples.
- Matrix Comparison (Myo & CKMB):
- Myo: n=125 for most comparisons (e.g., Liph/Pl vs Liph/WB), some n=127. Paired lithium heparin and EDTA specimens.
- CKMB: n=106 for Liph/Pl vs Liph/WB, others n=104, 103, 101. Paired lithium heparin and EDTA specimens.
- Precision (Myo & CKMB):
- Whole Blood: 3 lithium heparin whole blood samples, measured 5 times five replicates (total 25 measurements per sample level).
- Plasma: 3 lithium heparin plasma pools, measured across 20 test days, twice a day with 2 replicates (total 80 measurements per sample level).
Data Provenance: The studies were conducted "at one internal test site" for method comparison and "at three hospital laboratory sites" for matrix comparison. This indicates domestic (likely Denmark, where the manufacturer is located) or potentially international clinical laboratory settings. The data are prospective in the sense that they were generated specifically for these validation studies using prepared samples (diluted native specimens, spiked specimens, blank samples). They are not patient-outcome data or retrospective chart reviews.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- Not Applicable. For an in-vitro diagnostic device measuring analytes (myoglobin, CK-MB), the "ground truth" isn't established by human experts in the same way as, for example, image interpretation. The ground truth for these studies is the reference measurement from the original (predicate) device or the known concentration of prepared analytical samples.
4. Adjudication Method for the Test Set:
- Not Applicable. No human interpretation or adjudication is involved in determining the concentration of analytes in a blood sample by an immunoassay method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is relevant for AI systems that assist human readers in tasks like image interpretation. This document describes the analytical performance of an in-vitro diagnostic device that quantitatively measures biochemical markers. There are no human readers or AI assistance involved in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):
- Yes, in the context of an IVD. The performance data presented (linearity, LoD/LoQ, method comparison, precision) are all "standalone" in the sense that they demonstrate the analytical performance of the AQT90 FLEX system (analyzer and test kits) independent of human interpretation or intervention beyond proper sample handling and instrument operation. This isn't an "algorithm only" in the AI sense, but rather the performance of analytical machines.
7. The Type of Ground Truth Used:
- Reference Measurement/Known Concentration:
- For Linearity, LoB/LoD/LoQ, and Precision: The ground truth is established by preparing samples with known or precisely characterized concentrations of the analytes (e.g., diluted native specimens, spiked specimens, blank samples).
- For Method Comparison: The ground truth is the measurement obtained from the predicate device (the previously cleared version of the AQT90 FLEX system devices). The goal is to show agreement between the modified device and the predicate.
8. The Sample Size for the Training Set:
- Not Applicable. This document describes the validation of an in-vitro diagnostic device, not an AI model. Therefore, there's no "training set" in the machine learning sense. The device performs a chemical reaction and optical measurement based on established immunoassay principles, not a learned algorithm trained on data.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As there is no training set for an AI model, this question is not relevant.
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(179 days)
|
| Regulation Number | 21CFR 866.5680
Myoglobin Assay Diazyme Myoglobin Calibrator Set Diazyme Myoglobin Control Set
Regulation Number: 21 CFR 866.5680
The Diazyme Myoglobin Assay is for the quantitative determination of myoglobin in human serum and plasma. Measurement of myoglobin is used as an aid in the diagnosis of acute myocardial infarction. For in vitro diagnostic use only.
The Diazyme Myoglobin Calibrator Set is intended for use in the calibration of the Diazyme Myoglobin Assay. For in vitro diagnostic use only.
The Diazyme Myoglobin Control Set is intended for use as quality controls for the Diazyme Myoglobin Assay. For in vitro diagnostic use only.
The Diazyme Myoglobin Assay is based on a latex enhanced immunoturbidimetric assay. When an antigen-antibody reaction occurs between myoglobin in a sample and anti-myoglobin antibodies which have been sensitized to latex particles, agglutination occurs. This agglutination is detected as an absorbance change (570 nm), with the magnitude of the change being proportional to the quantity of myoglobin in the sample. The actual concentration is then determined by the interpolation from a calibration curve prepared from calibrators of known concentration.
The Diazyme Myoglobin Assay's acceptance criteria and performance are detailed across sections of the provided document. The study primarily relies on method comparison and precision evaluations to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Method Comparison | High correlation (R² close to 1) and a slope close to 1 with an intercept close to 0 when compared to the predicate device. | R² = 0.9855, Slope = 0.9526, Y-intercept = -4.2228. This is reported as correlating "well" with the predicate method. |
| Precision - Within-Run CV% | Not explicitly stated but generally expected to be low (e.g., typically |
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Regulation section: 21 CFR §866.5680, Myoglobin immunological test system
- 2.
: ADVIA® Chemistry Myoglobin Assay ADVIA® Chemistry Myoglobin Calibrator Regulation Number: 21 CFR §866.5680
The ADVIA® Chemistry Myoglobin assay is for in vitro diagnostic use in the quantitative measurement of myoglobin in human serum or plasma on the ADVIA® Chemistry systems. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.
The ADVIA Chemistry Myoglobin calibrator is for in vitro diagnostic use in the calibration of ADVIA® Chemistry system for Myoglobin assay.
The Myoglobin reagents are ready-to-use liquid reagents packaged for use on the automated ADVIA 1650 Chemistry system. They are supplied as a 100 tests/wedge, 2 wedges/kit. ADVIA Chemistry Myoglobin calibrator is a single analyte, human serum based product containing myoglobin derived from human heart source. The kit consists of 1 vial each of 4 calibrator levels which are lyophilized. The target concentrations of these calibrators are 50, 100, 200, and 720 ng/mL. The volume per vial (after reconstitution with deionized water) is 1.0 mL. Deionized water is recommended to be used as a zero calibrator.
Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes several performance characteristics and the results obtained for the ADVIA® 1650 Chemistry Myoglobin Assay. Since this is a submission for substantial equivalence to a predicate device, the "acceptance criteria" are implicitly the performance levels of the predicate device or generally accepted clinical laboratory standards as guided by CLSI documents. The reported performance of the new device is compared to these.
| Performance Characteristic | Acceptance Criteria (Implicit/Guidance) | Reported Device Performance (ADVIA® 1650 Chemistry Myoglobin Assay) |
|---|---|---|
| Precision | As per CLSI EP05-A2 guidance | Within-run SD/CV: 0.70-4.22 SD, 0.5-0.8% CV (depending on sample/concentration) |
| Total SD/CV: 1.41-10.23 SD, 1.8-6.2% CV (depending on sample/concentration) | ||
| Linearity/Assay Reportable Range | Linear range typically defined by predicate device or clinical needs | Linear/measuring range: 22 to 680 ng/mL |
| Limit of Blank (LoB) | As per CLSI EP17-A guidance | 12 ng/mL |
| Limit of Detection (LoD) | As per CLSI EP17-A guidance | 21 ng/mL |
| Limit of Quantitation (LoQ) | As per CLSI EP17-A guidance | 22 ng/mL |
| Method Comparison (Serum) | Good correlation with predicate device (ADVIA Centaur Myoglobin assay) | Correlation coefficient: 0.99 |
| Slope: 0.96 (95% CI: 0.95-0.98) | ||
| Intercept: 12.5 ng/mL (95% CI: 8.3-16.7) | ||
| Range tested: 19.9 - 684.0 ng/mL | ||
| Matrix Comparison (Plasma) | Good correlation with predicate device (ADVIA Centaur Myoglobin assay) | Correlation coefficient: 0.99 |
| Slope: 0.98 (95% CI: 0.96-1.00) | ||
| Intercept: 14.1 ng/mL (95% CI: 8.1-20.1) | ||
| Range tested: 18.9 - 624.1 ng/mL | ||
| Analytical Specificity (Interference) |
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(177 days)
name: AQT90 FLEX Myo Test Kit Class II Classification name: myoglobin, antiserum, control use (21 CFR. 866.5680
Classification name: myoglobin, antigen,
antiserum, control use,
(21 CFR. 866.5680), product
cartridge, AQT90 FLEX LQC Multi-CHECK, Levels 1-3 and AQT90 FLEX analyzer Regulation Number: 21 CFR §866.5680
AQT90 FLEX analyzer is for in vitro diagnostic use. The instrument is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point-of-care and laboratory settings.
AQT90 FLEX Myo Test is an in vitro diagnostic assay for the quantitative determination of myoglobin in EDTA or lithium-heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is indicated for use as an aid in the rapid diagnosis of heart disease, e.g. acute myocardial infarction.
AOT90 FLEX Myo CAL cartridge is for in vitro diagnostic use. For calibration adjustment of the Myo Test, as indicated on the cartridge, on the AQT90 FLEX analyzer.
AQT90 FLEX LQC Multi-CHECK, Levels 1-3, is for in vitro diagnostic use. For use with the AQT90 FLEX analyzer as a liquid quality control serum (LQC) to monitor the precision of laboratory testing procedures for the analytes listed on the specification insert.
The AOT90 FLEX is a cartridge-based immunoassay, based on time-resolved fluorescence using a europium (Eu) chelate as the fluorescent label. The test receptacles for the assay are 300 µL test cups, which contain the antibodies used for capture of the analyte, and the Eu chelate labeled antibodies used to trace the captured analyte. The sample is added to the test cup together with assay buffer. The cup is then incubated to allow formation of the immuno-complex, and subsequently washed to remove unbound antibodies and sample material. Finally, the cup is exposed to excitation light, and after a delay the emitted light generated by the fluorescent label is measured by single photon counting; this measurement cycle is repeated up to 3,300 times. The total count is then compared to an assay calibration curve to obtain a quantitative measurement of the analyte's concentration in the sample.
This technology uses dried reagents deposited in the test cups and in the calibration adjustment cups - no liquids other than the sample itself together with the assay buffer are required. Total assay time is less than 20 minutes.
Here's an analysis of the provided text regarding the AQT90 FLEX Myo Test, Myo CAL cartridge, and LQC Multi-CHECK, detailing the acceptance criteria and study information:
Acceptance Criteria and Device Performance
The provided document describes the AQT90 FLEX Myo Test being compared to a predicate device, the ARCHITECT STAT Myoglobin. The acceptance criteria are implicitly based on demonstrating substantial equivalence to the predicate device, particularly in terms of analytical performance.
A key performance metric presented is the correlation between the new device and the predicate device for Myoglobin measurements.
Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (AQT90 FLEX Myo Test) |
|---|---|---|
| Correlation with Predicate Device (Myoglobin) | High correlation (e.g., r² approaching 1.0) with the ARCHITECT STAT Myoglobin assay. | Whole Blood: y = 1.07 x ARCHITECT + 15, r² = 0.99 |
| Plasma: y = 1.02 x ARCHITECT + 13, r² = 0.99 | ||
| Reportable Range | Comparable to predicate device (ARCHITECT STAT Myoglobin: 0.0-1,200.0 ng/mL) | 20-900 ng/mL (µg/L) |
| Analytical Sensitivity | Comparable to predicate device (ARCHITECT STAT Myoglobin: ≤ 1.0 ng/mL at 95% CI) | Limit of quantitation 1 ng/mL (µg/L) |
| Imprecision (CV%) | Comparable to predicate device (ARCHITECT STAT Myoglobin: ≤ 10% for concentrations ≥ 40 ng/mL, 3.2-5.4% for controls) | Plasma: Within-run CV ≤ 2.5%, Total CV ≤ 5.2% |
| Whole Blood: Within-run CV ≤ 3.7%, Total CV ≤ 3.7% | ||
| Interference | No significant interferences (same as predicate) | No significant interferences |
Study Details
-
Sample sizes used for the test set and the data provenance:
- Whole Blood Samples: 157 samples
- Plasma Samples: 165 samples
- Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective, using existing samples to compare performance against a predicate device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This study is a comparative method study for an in vitro diagnostic device, comparing its quantitative measurements against a previously cleared predicate device. "Ground truth" in this context is the quantitative measurement provided by the predicate device, not expert interpretation of images or clinical outcomes.
-
Adjudication method for the test set:
- Not Applicable. As mentioned above, this is a quantitative comparison, not a study requiring adjudication of expert interpretations.
-
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 an in vitro diagnostic device for quantitative measurement of myoglobin, not an AI-assisted diagnostic imaging device that involves human readers.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes. The study presents the performance of the AQT90 FLEX Myo assay (the algorithm/device only) in measuring myoglobin concentrations and comparing these measurements directly to those obtained from the predicate device. There is no human-in-the-loop component in the measurement process itself.
-
The type of ground truth used:
- The "ground truth" for comparison was the measurements obtained from the predicate device: ARCHITECT STAT Myoglobin assay. This is considered a "reference standard" or "comparator method" for demonstrating substantial equivalence.
-
The sample size for the training set:
- Not explicitly stated in the provided text. The document describes a "comparison" study. For quantitative IVD devices, a "training set" in the machine learning sense is not typically discussed in 510(k) summaries as the device calibration and analytical method development process usually involves proprietary internal development and validation, separate from the clinical performance comparison against a predicate.
-
How the ground truth for the training set was established:
- Not explicitly stated. As noted above, typical IVD development involves extensive analytical validation. The "ground truth" for establishing the device's accuracy and precision during its development (analogous to a training phase) would involve reference materials, spiked samples, and potentially calibrators whose concentrations are established using highly accurate reference methods or certified reference materials. The provided document focuses on the comparison to the predicate device for regulatory submission.
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(345 days)
system | |
| Classification | 21 CFR 866.5680
Name: Elecsys® Myoglobin Immunoassay, Elecsys® Myoglobin STAT Immunoassay Regulation Number: 21 CFR §866.5680
Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.
Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin STAT assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.
The Elecsys Myoglobin Immunoassay includes two applications of the same reagents with different incubation times of 18 minutes (Myoglobin assay) and 9 minutes (Myoglobin STAT assay). The assay is a two-step sandwich immunoassay, using two different monoclonal antibodies directed against human Myoglobin, with streptavidin microparticles, and electrochemiluminescence detection. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode.
The acceptance criteria for the Elecsys Myoglobin Immunoassay and Elecsys Myoglobin STAT Immunoassay, along with the reported device performance, are detailed below. The study proves the device's substantial equivalence to a predicate device (Elecsys Myoglobin STAT assay K983176), rather than establishing new clinical effectiveness. Therefore, the information regarding multi-reader multi-case studies, expert adjudication, and detailed ground truth establishment for novel device performance is not fully applicable in the context of a 510(k) submission for substantial equivalence based on performance characteristics.
1. Table of Acceptance Criteria and the Reported Device Performance
| Feature | Acceptance Criteria (Predicate: Elecsys Myoglobin STAT assay K983176 Performance) | Reported Device Performance (Elecsys Myoglobin and Myoglobin STAT) |
|---|---|---|
| Measuring Range | 15-3000 ng/mL | 21-3000 ng/mL |
| Expected values (Men) |
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(364 days)
Myoglobin and Access Myoglobin Calibrators on the Access Immunoassay Systems
Regulation Number: 21 CFR §866.5680
Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems. Measurement of myoglobin aids in the rapid diagnosis of heart and renal diseases.
The Access Myoglobin reagent and calibrators, the Access Immunoassay Analyzers comprise the Access Immunoassay Systems for the quantitative determination of cardiac Myoglobin in human serum and plasma.
The provided 510(k) summary focuses on a single performance characteristic: imprecision. The submission is for a modified version of an already cleared device, and the only change noted is to the acceptable imprecision range in the Instructions For Use (IFU).
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from modified IFU) | Reported Device Performance (Myoglobin) |
|---|---|---|
| Total Imprecision (%CV) | ≤ 10% across the expected physiological range | 7.32% CV to 9.25% CV |
The reported device performance (7.32% CV to 9.25% CV) falls within the updated acceptance criteria (≤ 10% CV).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The summary mentions "concentrations from approximately 79 to 2405 ng/mL" for imprecision testing, but not the number of individual samples or replicates used.
- Data Provenance: Not explicitly stated. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of submission. The device is an immunoassay for quantitative determination of myoglobin, and the "ground truth" for evaluating imprecision is determined by statistical analysis of repeat measurements, not by expert interpretation of samples.
4. Adjudication Method for the Test Set
This information is not applicable as it relates to expert consensus for ground truth, which is not relevant for imprecision studies of an immunoassay.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This submission is for an immunoassay for myoglobin, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a laboratory immunoassay device, not an algorithm, and does not involve human-in-the-loop performance in the same way as an AI-driven image analysis tool. The performance described (imprecision) is inherently "standalone" in the sense that it measures the inherent variability of the assay itself.
7. The Type of Ground Truth Used
The ground truth for imprecision studies is the measured value itself and its statistical distribution. Repeated measurements of the same sample are used to assess the variability (imprecision) of the assay. There isn't an external "truth" in the way there would be for disease diagnosis (e.g., pathology).
8. The Sample Size for the Training Set
This information is not applicable. This device is a biochemical assay and does not involve machine learning models that require a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for this type of device.
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(126 days)
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21 CFR 862.1215,
Fluorometric Method, CPK or Isoenzymes
Product Code: JHX
21 CFR 866.5680
Fluorometric Method, CPK or Isoenzymes Product Code: JHX
21 CFR 866.5680, Myoglobin, Antigen, Antiserum
The Triage® CardioProfilER® Panel is a fluorescence immunoassay to be used with the Triage Meters for the quantitative determination of Creatine Kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure), an aid in the risk stratification of patients with heart failure, and an aid in the risk stratification of patients with acute coronary syndromes.
The Triage® Profiler S.O.B.TM (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage Meters for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peotide, and cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism and an aid in the risk stratification of patients with acute coronary syndromes.
The Triage CardioProfilER Panel is a single-use device containing murine monoclonal and polyclonal antibodies against CK-MB, murine monoclonal and polyclonal antibodies against myoglobin, murine monoclonal and goat polyclonal antibodies against troponin I and murine monoclonal and polyclonal antibodies against BNP labeled with a fluorescent dye and immobilized on the solid phase, and stabilizers. Additionally, there are builtin control features that ensure that the test was performed properly and the reagents were functionally active.
The Triage Profiler S.O.B. Panel is a single-use device containing murine monoclonal and polyclonal antibodies against CK-MB, murine monoclonal and polyclonal antibodies against myodlobin, murine monoclonal and qoat polyclonal antibodies against troponin I, murine monoclonal antibodies against D-dimer, and murine monoclonal and polyclonal antibodies against BNP labeled with a fluorescent dye and immobilized on the solid phase, and stabilizers. Additionally, there are built-in control features that the test was performed properly and the reagents were functionally active.
The Test Cartridges are inserted into the Triage Meter and results for each analyte are measured and displayed on the display screen or printout. Internal assay controls (positive and negative controls) and automatic endpoint detection technology is used to indicate assay completion.
This 510(k) summary (K080269) describes the Triage CardioProfilER Panel and the Triage Profiler S.O.B. Panel, which are fluorescence immunoassays used with Triage Meters for the quantitative determination of various cardiac and circulatory markers in EDTA whole blood and plasma specimens.
The submission focuses on establishing substantial equivalence to a predicate device, the Biosite Triage BNP Test (K051787), particularly for the use of BNP in risk stratification of heart failure patients.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain specific quantitative acceptance criteria or detailed device performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard) for the Triage CardioProfilER Panel or the Triage Profiler S.O.B. Panel.
Instead, the submission states that:
- "The devices and test methods described in this Premarket Notification for the Triage CardioProfilER Panel and the Profiler S.O.B. Panel are identical in principle, reagents and procedure to their predecessors."
- "More specifically, the BNP assays included in these panels are identical to the BNP assay used in the Triage BNP Test (K051787)."
- "Therefore, the use of the Triage CardioProfilER and the Profiler S.O.B. Panels as an aid in the risk stratification of patients with heart failure is substantially equivalent to the predicate method."
This indicates that the acceptance criteria for these devices are primarily based on demonstrating substantial equivalence to the previously cleared predicate device (K051787) through comparison of their identical principles, reagents, and procedures, rather than presenting new performance data against specific numerical targets.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify any sample sizes used for a test set or data provenance for a study proving device performance. The submission relies on the substantial equivalence of the new devices to the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. No de novo study featuring a test set with ground truth established by experts is described in the provided document.
4. Adjudication Method for the Test Set
Not applicable. No de novo study featuring a test set with adjudication is described in the provided document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The devices are diagnostic assays, not AI-assisted interpretation tools for image analysis.
6. If a Standalone (Algorithm Only) Performance Study Was Done
The document does not describe a standalone performance study in the sense of an independent algorithm's performance. The devices are immunoassay panels that produce quantitative measurements. Their performance is indirectly addressed by claiming identity to previously-cleared assays within the predicate device.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for performance evaluation of the new devices, as it primarily relies on substantial equivalence. For the predicate device's clearance (K051787), it would have been expected that clinical diagnosis, pathology, or patient outcomes data were used as ground truth for establishing the performance characteristics of the individual assays (CK-MB, myoglobin, troponin I, BNP, D-dimer).
8. The Sample Size for the Training Set
Not applicable. The document does not describe an AI or machine learning model that would require a "training set" in the context of typical AI device submissions. These are immunoassay panels.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no mention of a training set or its associated ground truth establishment methods for these immunoassay panels.
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(190 days)
ARCHITECT STAT Troponin-1 Immunoassay, ARCHITECT STAT Myoglobin Immunoassay Regulation Number: 21 CFR 866.5680
ARCHITECT STAT Troponin-I is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of cardiac troponin-I in human serum or plasma on the ARCHITECT i 2000SR System. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI).
ARCHITECT STAT Myoglobin is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of myoglobin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. Myoglobin values are used to assist in the diagnosis of myocardial infarction (MI).
Not Found
This is an FDA Premarket Notification (510(k)) letter for the ARCHITECT STAT Troponin-I Immunoassay and ARCHITECT STAT Myoglobin Immunoassay. It confirms that the devices are substantially equivalent to legally marketed predicate devices.
However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, or MRMC studies.
This type of FDA letter is an approval document, not a study report. To find the information you're looking for, you would typically need to consult:
- The original 510(k) submission document itself (which includes the detailed performance data).
- The device's Instructions for Use (IFU) or package insert, which often summarizes performance characteristics.
- Clinical studies or validation reports associated with the device, usually referenced or summarized in the 510(k) submission.
Since the provided text does not contain the requested information, I cannot complete the table or answer the specific questions about the study design, sample sizes, or ground truth.
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(272 days)
|
| Classification Name: | §866.5680
Cardiac Markers reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure cardiac marker analytes.
ABX PENTRA CK-NAC CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the total creatine kinase in human serum and plasma based on an optimized UV test.
Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive. Duchenne-type muscular dystrophy.
The ABX PENTRA CK Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CK-MB RTU and ABX PENTRA CK-NAC methods.
ABX PENTRA Myoglobin CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of myoqlobin (an oxygen storage protein found in muscle) in human serum and plasma based on a latex-enhanced immunoturbidimetric assay.
Measurements of myoglobin aids in the rapid diagnosis of heart or renal disease.
The ABX PENTRA Myoglobin Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Myoglobin CP method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA Immuno II Control L/H is for use in quality control by monitoring accuracy and precision.
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.
The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.
All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.
The ABX PENTRA CK NAC CP is an in vitro diagnostic assay for the quantitative determination of total creatine kinase in human serum and plasma based on an optimized UV test. The assay is composed of a bi-reagent cassette, with 26 ml and 6.5 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Myoglobin CP is an in vitro diagnostic assay for the quantitative determination of myoglobin in human serum and plasma based on a latex-enhanced immunoturbidimetric test. The assay is composed of a bi-reagent cassette, with 15 ml and 9.5 ml compartments. Reagents are chemical solutions with chemical additives and substances of animal origin.
The ABX PENTRA Myoglobin Cal is a liquid calibrator prepared from a dilution of purified myoglobin positive human sera. It is used for the calibration of the myoglobin assay. The assigned values are given on the vials. This calibrator is provided in five vials of 1 ml.
The ABX PENTRA CK Control is a lyophilized assayed control prepared from a bovine serum albumin with chemical additives and material of biological origin. It has to be used for the quality control of the creatine kinase assay. The assigned values are given in the enclosed annex. This calibrator is provided in 4 vials of 3 ml.
The ABX PENTRA Immuno II Control L/H is a lyophilized assayed control prepared from a stabilized pool of human sera. It has 2 levels (Low and High) to be used for the quality control of the myoglobin assay. The assigned values are given in the enclosed annex. Each level of this control is provided in one vial of 3 ml.
The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml.
The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.
This submission describes various reagents, controls, and calibrators for in vitro diagnostic use with the Horiba ABX Pentra 400 clinical chemistry analyzer. The performance data focuses on establishing substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided are primarily performance characteristics of the various reagents, controls, and calibrators.
ABX PENTRA CK NAC CP (Reagent for Total Creatine Kinase)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sample type | Serum & plasma |
| Detection limit | 8 U/l |
| Accuracy and Precision | CV Total |
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