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510(k) Data Aggregation
(90 days)
DCN
CardioPhase hsCRP is an in-vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in human serum, and heparin and EDTA plasma by means of particle enhanced immunonephelometry using the BN II and BN ProSpec® System. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, is observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. High sensitivity CRP (hsCRP) measurements may be used as an independent risk marker for the identification of individuals at risk for future cardiovascular disease. Measurements of hsCRP, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.
The CardioPhase hsCRP assay is an in-vitro diagnostic reagent for the quantitative determination of Creactive protein (CRP) in human serum, and heparinized and EDTA plasma by means of particleenhanced immunoassay determination. The assay is traceable to the international standard ERM-DA474/IFCC. N Rheumatology Standard SL (cleared under K964527) is used for the establishment of reference curves for the immunonephelometric determination of C-reactive protein on the BN II and BN ProSpec® Systems. This calibrator consists of a mixture of human sera and elevated concentrations of CRP. The CardioPhase hsCRP reagent is a suspension of polystyrene (Latex) particles to which mouse monoclonal anti-human CRP antibodies (
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the method comparison study were that "Results from each lot of CardioPhase hsCRP met the predefined acceptance criteria." While the specific numerical acceptance criteria (e.g., maximum allowable bias) are not explicitly detailed in a table format within the provided text, the successful outcome is stated, and the resulting performance is presented as follows:
| Performance Metric | Lot 1 CardioPhase hsCRP | Lot 2 CardioPhase hsCRP | Lot 3 CardioPhase hsCRP |
|---|---|---|---|
| Sample Size (N) | 119 | 116 | 113 |
| Range | 5.523 – 197.746 mg/L | 5.378 – 199.150 mg/L | 5.501 – 199.503 mg/L |
| Regression Equation (y = mx + b) | y = 0.959x + 0.932 mg/L | y = 0.955x + 0.584 mg/L | y = 1.032x - 0.070 mg/L |
| Correlation Coefficient (r) | 0.994 | 0.996 | 0.994 |
| Coefficient of Determination (r²) | 0.989 | 0.991 | 0.989 |
| Observed Max Predicted Bias (for 10, 100, 150, 200 mg/L) | 5.2% (relative) | Not explicitly stated per lot, but given as overall maximum. | Not explicitly stated per lot, but given as overall maximum. |
| Overall Max Predicted Bias | 5.2% (relative) | 5.2% (relative) | 5.2% (relative) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size:
- Lot 1: N = 119
- Lot 2: N = 116
- Lot 3: N = 113
- The total number of samples used in the method comparison study is the sum of these, which is 348.
- Data Provenance: The study was conducted at the "company site in Marburg, Germany." The samples used were "Native serum samples." The text does not explicitly state whether the samples were retrospective or prospective, but the phrasing "Native serum samples were measured" suggests they were existing samples at the time of the study rather than collected specifically for this study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the text. The study describes a method comparison between two quantitative laboratory assays (CardioPhase hsCRP and RCRP Flex reagent cartridge). For this type of in-vitro diagnostic device, the "ground truth" is typically defined by the reference method or the predicate device's measurement, not by human expert consensus or adjudication in the way it might be for image-based diagnostic AI.
4. Adjudication Method for the Test Set
Not applicable for this type of in-vitro diagnostic device and study design. The comparison is quantitative between two analytical methods, not involving human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for image analysis or other diagnostic tools where human interpretation is a key component. The CardioPhase hsCRP is an in-vitro diagnostic reagent for quantitative measurement, which does not involve human readers in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the study described is a standalone performance study of the CardioPhase hsCRP assay compared to a predicate device. It evaluates the device's ability to quantitatively determine C-reactive protein concentrations independently. No human-in-the-loop component is mentioned for the performance evaluation itself.
7. The Type of Ground Truth Used
The "ground truth" for this method comparison study was established by the predicate device, RCRP Flex® reagent cartridge, which runs on the Dimension clinical chemistry system. Both the proposed device (CardioPhase hsCRP) and the predicate device are traceable to the international standard ERM-DA474/IFCC for C-reactive protein measurements. Therefore, the predicate device's measurements serve as the reference for comparison, and that reference itself is traceable to an international standard.
8. The Sample Size for the Training Set
The text does not specify a separate training set or its sample size. The described "method comparison study" is focused on verifying the performance of the device for regulatory submission, using a test set of samples. For in-vitro diagnostic devices, "training sets" are usually relevant for developing the assay itself (e.g., optimizing reagent concentrations, reaction conditions), but this information is not typically detailed in a 510(k) summary with respect to a "training set" of patient data for algorithm development.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" of patient samples is described in the provided text in the context of algorithm development, this information is not applicable. The assay itself relies on a biochemical principle and calibration traceable to an international standard (ERM-DA474/IFCC), and the calibration is established using N Rheumatology Standard SL, which is traceable to Siemens internal Master Calibrator, which is in turn directly traceable to ERM-DA474/IFCC.
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(333 days)
DCN
The C-Reactive Protein Extended Range (RCRP) method used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Measurement of C-Reactive Protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
The RCRP method is based on a particle enhanced turbidimetric immunoassay (PETIA) technique. Synthetic particles coated with antibody to C-Reactive Protein (AbPR) aggregate in the presence of C-Reactive Protein in the sample. The increase in turbidity which accompanies aggregation is proportional to the C-Reactive Protein concentration.
This document describes the RCRP Flex® reagent cartridge, an in vitro diagnostic test for the quantitative determination of C-Reactive Protein (CRP) in human serum and plasma. The submission is a special 510(k) for a modified device, primarily due to an update in traceability from IFCC CRM 470 to ERM-DA474/IFCC reference material and a change in the analytical measurement range (AMR).
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and observed performance are provided for the method comparison studies.
| Attribute | Acceptance Criteria | Reported Device Performance (Modified RCRP vs. Predicate RCRP) | Pass/Fail | Reported Device Performance (RCRP Dimension RXL vs. N High Sensitivity CRP) | Pass/Fail |
|---|---|---|---|---|---|
| Slope | $1.00 \pm 0.1$ | 0.99 | Pass | 0.95 | Pass |
| y-intercept | $0.0 \pm 2.0$ mg/L | -0.5 mg/L | Pass | -1.6 mg/L | Pass |
| Correlation Coefficient (r) | $\geq 0.9600$ | 1.000 | Pass | 0.997 | Pass |
Detection Capability (LoB, LoD, LoQ)
| Specimen Type | Detection Capability | Acceptance Criteria | Result (mg/L / mg/dL) |
|---|---|---|---|
| Serum and Lithium Heparin Plasma | LoB | ≤ LoD | 0.6 mg/L (0.06 mg/dL) |
| LoD | ≤ LoQ | 1.0 mg/L (0.10 mg/dL) | |
| LoQ | ≤ 5.0 mg/L | 5.0 mg/L (0.50 mg/dL) |
Interference
| Endogenous Substance Tested | Endogenous Substance Concentration | Analyte Concentration | Acceptance Criteria (Bias) | Bias (%) |
|---|---|---|---|---|
| Hemoglobin (hemolysate) | [500 mg/dL] 5.0 g/L | [11.6 mg/L] 1.16 mg/dL | Bias exceeding 10% is interference | 0% |
| Bilirubin (Unconjugated) | [40 mg/dL] 684 µmol/L | [11.7 mg/L] 1.17 mg/dL | Bias exceeding 10% is interference | 2% |
| Lipemia (Intralipid) | [250 mg/dL] 2.5 g/L | [11.8 mg/L] 1.18 mg/dL | Bias exceeding 10% is interference | -9% |
| Lipemia (Triglyceride Fraction) | [750 mg/dL] 7.5 g/L | [11.1 mg/L] 1.11 mg/dL | Bias exceeding 10% is interference | -7% |
2. Sample Sample Size Used for the Test Set and Data Provenance
-
Method Comparison – Modified RCRP assay vs Predicate RCRP assay:
- Sample Size: 132 individual human native serum samples.
- Data Provenance: Samples were obtained from "specimen vendors". The country of origin is not specified, nor is whether the data is retrospective or prospective.
-
Method Comparison - RCRP assay on Dimension RXL system vs N High Sensitivity CRP on the BN™ System:
- Sample Size: 171 for the overall comparison (5.3 to 241.3 mg/L) and 39 for the narrower range (5.3 to 20.2 mg/L).
- Data Provenance: This study involved "re-analyzed historical IFU data." The original provenance (country, retrospective/prospective) of this historical data is not specified.
-
Linearity Testing: Not specified, but generally involves a set of diluted samples or spiked matrix covering the analytical measurement range.
-
Detection Capability (LoB, LoD, LoQ): Not specified.
-
Precision:
- Sample Size: 6 serum samples, analyzed with N=10 replicates each day for 5 days (total of 50 replicates per sample level).
-
Specimen Equivalency:
- Sample Size: 73 samples.
- Data Provenance: Not specified, but likely from specimen vendors similar to the method comparison.
-
Interference:
- Sample Size: Not explicitly stated, but typically involves a control sample and test samples (with interferent) for assessment of bias.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes an in vitro diagnostic (IVD) test, specifically an immunoassay for C-Reactive Protein. The "ground truth" for such devices is typically established through a reference method or known concentrations of certified reference materials, not through expert consensus or interpretation in the same way an imaging AI might.
- No human experts (e.g., radiologists) were used to establish ground truth for this type of device. The assessment is based on measured concentrations against established reference standards.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth for an IVD device like this is based on quantitative measurements and reference materials, not subjective interpretations requiring 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 an in vitro diagnostic assay, not an AI-powered image analysis or diagnostic assist device that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is a standalone algorithm/reagent system designed for automated quantitative measurement on a clinical chemistry system. Its performance is evaluated intrinsically through various analytical studies (method comparison, linearity, precision, detection capability, interference) without human-in-the-loop performance influencing the measurement itself. The results are then interpreted by clinicians.
7. The Type of Ground Truth Used
The ground truth for this device is based on:
- Reference Materials: For standardization, the device is traceable to ERM-DA474/IFCC reference material (and previously IFCC CRM 470). These are internationally recognized certified reference materials for CRP.
- Comparative Methods: The performance is benchmarked against a predicate RCRP assay and the N High Sensitivity CRP on the BN™ System. These are established laboratory methods.
- Clinical Laboratory Standards (CLSI): The studies follow guidelines from CLSI, which define how to robustly evaluate analytical performance parameters like precision, linearity, and detection limits.
8. The Sample Size for the Training Set
This document does not describe a machine learning or AI model that requires a distinct "training set" in the conventional sense. The device is a chemical reagent and assay system. Its "training" or development would involve extensive experimentation and optimization during the R&D phase to ensure reagent stability, reaction kinetics, and signal transduction are robust and accurate. This is not typically quantified as a "training set size" like in AI/ML contexts.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/ML device with a defined training set and ground truth in that context. The "ground truth" for the development of such an assay would be through rigorous chemical and biological characterization, using known concentrations of analytes, reference materials, and established analytical chemistry principles.
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(203 days)
DCN
Tina-quant® C-Reactive Protein IV is an immunoturbidimetric assay for the in vitro quantitative determination of CRP in human serum and plasma on cobas c systems.
A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and plasma. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.
The Tina-quant® C-Reactive Protein IV reagent will be a liquid ready to use 2 component particle enhanced immunoturbidimetric assay.
Reagents - working solutions
R1: TRIS* buffer with bovine serum albumin; preservatives
R2 Latex particles coated with anti-CRP (mouse) in glycine buffer; immunoglobulins (mouse); preservative
- TRIS= Tris(hydroxymethyl)-aminomethane
The Tina-quant® C-Reactive Protein IV assay will be based on the DUREL technology (dual radius enhanced latex - technology) which is also used in C-Reactive Protein Gen.3 predicate method. Human CRP agglutinates with latex particles coated with monoclonal anti-CRP antibodies. The aggregates are determined turbidimetrically.
The document describes the non-clinical performance evaluation of the Tina-quant® C-Reactive Protein IV device. Here's a summary of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Performance Characteristic | Acceptance Criteria or Expected Outcome (or Predicate Performance) | Reported Device Performance (Tina-quant® C-Reactive Protein IV) |
|---|---|---|
| Precision | Repeatability (CV%) | Repeatability (CV%) |
| Precinorm Protein | Predicate: 1.2% | 1.3% |
| Precipath Protein | Predicate: 1.3% | 1.6% |
| Human Serum Samples | Predicate: 3.6%, 1.6%, 1.2% (for different samples) | 1.5% (Serum 2), 1.6% (Serum 3), 2.2% (Serum 4), 2.0% (Serum 5), 1.3% (Serum 6) |
| Intermediate Precision (CV%) | Intermediate Precision (CV%) | Intermediate Precision (CV%) |
| Precinorm Protein | Predicate: 2.9% | 1.5% |
| Precipath Protein | Predicate: 1.9% | 1.9% |
| Human Serum Samples | Predicate: 11.1%, 3.9%, 1.7% (for different samples) | 1.6% (Serum 2), 1.9% (Serum 3), 2.4% (Serum 4), 2.4% (Serum 5), 1.8% (Serum 6) |
| Analytical Sensitivity | ||
| Limit of Blank (LoB) | Claimed LoB: 0.2 mg/L | Observed LoB: 0.0700 mg/L (Meets criterion: Observed is less than claimed) |
| Limit of Detection (LoD) | Claimed LoD: 0.3 mg/L | Observed LoD: 0.137 mg/L (Meets criterion: Observed is less than claimed) |
| Limit of Quantitation (LoQ) | Claimed LoQ: 3 mg/L (Predicate was 0.6 mg/L, but 3 mg/L is claimed for the candidate device. The study shows the device is capable of quantifying lower.) | Observed LoQ: 0.313 mg/L (Exceeds criterion as it is much lower than the claimed 3 mg/L, indicating better performance. The claimed measuring range for Tina-quant® C-Reactive Protein IV starts at 3 mg/L, so the LoQ of 0.313 mg/L is well below the lowest reportable value, which is acceptable.) |
| Linearity/Assay Reportable Range | Consistent with predicate, good correlation (R > 0.999), and linearity across the intended measuring range. | Linear Regression: y=1.002x-0.0169; Pearson correlation coefficient (R)=0.9994. Claimed Measuring Range: 3 to 350 mg/L. (Meets criterion) |
| Endogenous Interference | No interference up to specified levels for lipemia, hemolysis, bilirubin, ditauro bilirubin, albumin, IgG, and RF Factor. | No interference up to: Lipemia: 1000 L Index; Hemolysis: 1000 H Index; Bilirubin: 60 I Index; Ditauro Bilirubin: 60 I Index; Albumin: 60 g/L; IgG: 50 g/L; RF Factor: 1200 IU/mL. (Meets criterion) |
| Exogenous Interference (Drugs) | No interference up to specified drug concentrations. | No interference up to: N-Acetylcysteine: 1660 mg/L; Ampicillin-Na: 1000 mg/L; Ascorbic acid: 300 mg/L; Cefoxitin: 6600 mg/L; Heparin: 5000 IU/L; Levodopa: 20 mg/L; Methyldopa: 22.5 mg/L; Metronidazole: 200 mg/L; Doxycyclin: 50 mg/L; Acetylsalicylic acid: 1000 mg/L; Rifampicin: 60 mg/L; Ticarcillin: 225 mg/L; Penicillamin: 24 mg/L; Phenylbutazone: 400 mg/L; Cyclosporine: 5 mg/L; Acetaminophen: 200 mg/L; Ibuprofen: 500 mg/L; Theophylline: 100 mg/L. (Meets criterion) |
| Sample Matrix Comparison | Good agreement between serum and plasma types (Li-Heparin, K2-EDTA, K3-EDTA) with correlation (r) close to 1 and slope near 1, intercept near 0. | Linear Regression: Serum vs. Li-Heparin: y = 1.029x - 0.192, r = 0.999; Serum vs. K2-EDTA: y = 1.024x - 0.201, r = 0.999; Serum vs. K3-EDTA: y = 1.024x - 0.258, r = 0.999. (Meets criterion) |
| Method Comparison to Predicate | Strong correlation with the predicate device (R > 0.999) and slope near 1, intercept near 0. | Passing/Bablok Regression: Slope = 0.985, Intercept = +0.278, Correlation (Pearson) = 0.999. Weighted Deming Regression: Slope = 0.979, Intercept = +0.296, Correlation = 0.999. (Meets criterion for substantial equivalence) |
| Stability | Meet Roche Diagnostic's claims on package labeling. | Data supports Roche Diagnostic's claims. (Meets criterion) |
Study Details:
The performance studies were designed in accordance with CLSI guidelines (EP5-A3, EP17-A2, EP6-A) and FDA guidance for CRP assays.
2. Sample sized used for the test set and the data provenance:
- Precision (Repeatability & Intermediate Precision):
- Controls: Precinorm Protein and Precipath Protein.
- Human Serum Samples: 4 human serum samples were used to evaluate repeatability and intermediate precision, plus 6 human serum samples for the specific results documented in the table. Each sample/control was analyzed with multiple aliquots (e.g., 2 aliquots for 21 days for precision).
- Data Provenance: Not explicitly stated (e.g., country of origin), but it's noted as "human serum samples." The studies are prospective for the device evaluation.
- Analytical Sensitivity (LoB, LoD, LoQ):
- LoB: Ten aliquots of analyte-free saline (N=60 determinations per lot).
- LoD: Five samples of low analyte level human serum (N=60 determinations per lot).
- LoQ: Nine low concentration human serum samples (N=25 determinations per sample per lot).
- Data Provenance: Not explicitly stated for specific origin, but uses "analyte free saline" and "human serum."
- Linearity/Assay Reportable Range:
- Samples: Dilution series prepared from native unmodified human serum sample pools, resulting in 15 levels. Each level measured in triplicate (n ≥ 3).
- Data Provenance: "native unmodified human serum sample pools."
- Endogenous Interference:
- Samples: Effects determined at 2 CRP levels (5-10 mg/L and 35-100 mg/L) utilizing 11-level serial dilution sets of interfering substances. Each level measured in triplicate.
- Data Provenance: Not explicitly stated, likely lab-prepared samples with added interferents.
- Exogenous Interference (Drugs):
- Samples: Effects determined at 2 CRP levels (5-10 mg/L and 35-100 mg/L) using pooled samples spiked with drugs. N=5 results per drug.
- Data Provenance: Lab-prepared samples with added drugs.
- Sample Matrix Comparison:
- Samples: Native samples from single donors drawn into serum, Li-Heparin, K2-EDTA, and K3-EDTA plasma primary tubes.
- Range Tested: 3.34 to 344 mg/L.
- Data Provenance: "native samples (single donors)."
- Method Comparison to Predicate:
- Samples: One hundred ten (N=110) native, unaltered serum samples.
- Data Provenance: "native, unaltered serum samples."
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)
This device is an in-vitro diagnostic (IVD) assay for quantitative determination of C-Reactive Protein (CRP). The "ground truth" for such devices is established by reference methods, certified reference materials, and accepted analytical techniques, not by expert interpretation in the same way imaging studies might use radiologists. The measurements for the test set samples (e.g., CRP concentrations) are determined by the analytical methods themselves, often verified against established standards or predicate devices. There is no mention of human experts establishing ground truth for the test set in the context of interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
For IVD assays, ground truth is typically analytical, not based on expert adjudication of observations. The "truth" is the measured concentration, often confirmed by multiple replicates or comparative methods, as opposed to a consensus reading process found in clinical imaging studies. Therefore, no adjudication method (like 2+1 or 3+1) is applicable or described here.
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
No, an MRMC comparative effectiveness study was not performed. This device is an in-vitro diagnostic instrument for measuring a biomarker (CRP). It does not involve human readers interpreting images or results that would be "assisted" by AI. The device directly produces quantitative results.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance studies described are for the device (Tina-quant® C-Reactive Protein IV on a cobas c 501 analyzer) operating in a standalone capacity. It measures CRP in samples without human intervention in the interpretive output. The studies evaluate the analytical performance of the instrument and reagents themselves.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this IVD device is based on:
- Analytical Standards: For LoB, LoD, LoQ, and Linearity, ground truth is established through statistical derivation from measurements of samples with known low or varying concentrations, or through the use of analyte-free samples or reference materials.
- Predicate Device Comparison: The "Method Comparison to Predicate" establishes the ground truth by comparing the device's results against a legally marketed and established predicate device (Roche Diagnostics C-Reactive Protein Gen.3), assuming the predicate provides the accepted reference values.
- Spiked Samples/Known Concentrations: For interference studies (endogenous and exogenous), ground truth is established by adding known amounts of interfering substances or drugs to samples with known CRP concentrations and observing the recovery of the expected CRP value.
- Certified Reference Materials (CRM): The "Traceability/Standardization" indicates that the candidate device is standardized against the certified reference material of IRMM (Institute for Reference Materials and Measurements) ERM-DA474/IFCC. This is a primary source of analytical ground truth.
8. The sample size for the training set
This document describes a premarket notification (510(k)) submission for a medical device. The "training set" concept is typically associated with machine learning or AI models. This device is an immunoturbidimetric assay, which is a traditional analytical chemistry method, not an AI/ML system. Therefore, there is no "training set" in the context of machine learning. The studies described are performance evaluations to demonstrate that the device meets its analytical specifications.
9. How the ground truth for the training set was established
As there is no "training set" for an AI/ML model for this traditional IVD assay, this question is not applicable. The device's performance is validated against analytical performance criteria as described above in point 7.
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(269 days)
DCN
The Optilite High Sensitivity C-Reactive Protein Kit is intended for the quantitative in vitro measurement of C-Reactive Protein in serum using the Binding Site Optilite analyser for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. This test should be used in conjunction with other laboratory and clinical findings.
The Optilite High Sensitivity C-Reactive Protein Kit is comprised of latex reagent, single calibrator, controls (high and low) and reaction buffer in liquid form. The reagents contain 0.099% sodium azide as preservative.
Acceptance Criteria and Study for Optilite High Sensitivity C-Reactive Protein Kit
Here's a breakdown of the acceptance criteria and the study results for the Optilite High Sensitivity C-Reactive Protein Kit, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Implicit from Study Design) | Reported Device Performance (Optilite Kit) |
|---|---|---|
| Precision | Total Precision: %CV 3mg/L. |
- Method Comparison with Predicate Device: 391 serum samples (302 reported results within the measuring range). These included 87 normal donors and 304 clinical samples.
- Expected Values/Reference Range Verification: 50 adult donor samples.
Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given "The Binding Site Group, Ltd." is based in the UK, it's highly probable that the studies were conducted there. The nature of the studies (e.g., precision, linearity, method comparison) generally implies prospective testing of samples for analytical performance, though the 304 "clinical samples" in the method comparison could be retrospective or a mix.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is an in vitro diagnostic (IVD) for quantitative measurement of a biomarker (C-Reactive Protein). The "ground truth" for its performance is established through comparisons with reference methods, calibrated materials, and statistical analysis of assay performance (precision, linearity, detection limits), rather than through expert consensus on qualitative interpretation.
4. Adjudication Method for the Test Set:
Not applicable, as this is a quantitative IVD device. Test results are numerical and assessed against predefined analytical performance criteria, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic imaging devices where human readers interpret images. The Optilite Kit is an automated immunoassay system, not an imaging device requiring human interpretation.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, a standalone study of the algorithm (the Optilite High Sensitivity C-Reactive Protein Kit and Optilite analyser) was performed. All the analytical performance characteristics (precision, linearity, detection limits, analytical specificity) and method comparison studies described are standalone evaluations of the device's performance without human intervention in the result generation process.
7. The Type of Ground Truth Used:
The ground truth for this device is established through:
- International Reference Standards: The assay is traceable to the international reference standard ERM-DA474 for calibration.
- Statistical Definitions: For precision (CV%), linearity (deviation from linearity), detection limits (LoB, LoD, LoQ), established statistical methodologies (CLSI EP5-A3, EP6-A, EP17-A2) define the acceptable "ground truth" or performance targets.
- Reference Methods/Predicate Device: For method comparison, the results from the legally marketed predicate device (C-Reactive Protein High Sensitive Test System for Cobas Integra Instruments) serve as the comparative "ground truth" for demonstrating substantial equivalence.
- Clinical Relevance: The reference interval (
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(161 days)
DCN
The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injurv to body tissues and for evaluation of infection, tissue injurv, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings.
The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser.
The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.
The Optilite C-Reactive Protein Reagent is comprised of a dual wedge containing the following:
Antiserum: Supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, TRIS pH 8.0.
Reaction Buffer: Containing 0.099% sodium azide, TRIS pH 7.5 as preservatives.
The Optilite C-Reactive Protein Calibrator is comprised of the following: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative.
The Optilite C-Reactive Protein Controls are comprised of the following: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative.
The Binding Site Optilite C-Reactive Protein Reagent, Calibrator, and Controls have several performance characteristics, and the report details the studies conducted to verify these characteristics against pre-defined acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | Total precision (%CV |
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(234 days)
DCN
The MSD CRP Kit is intended for in vitro diagnostic use in the quantitative determination of C-reactive protein (CRP) in human serum using the MESO SECTOR S 700 instrument. Measurement of CRP aids in the evaluation of infection, tissue injury, and inflammatory disorders. This test will be performed in a hospital or clinical laboratory setting by trained laboratory personnel. The target patient population for the MSD CRP Assay is symptomatic adults. Clinicians should utilize the results of the MSD CRP Assay for diagnosis of inflammatory diseases in conjunction with other clinical and laboratory findings.
The SECTOR S 700 instrument is intended for the in-vitro determination of analytes in bodily fluids. This instrument is not intended for Point-of-Care use.
The MSD CRP Assay Kit is a quantitative in-vitro diagnostic assay for conventional measurement of C-reactive protein in human serum. The CRP Assay Kit is designed for use with the MESO SECTOR® S 700 Instrument. The kit components include the 96-well CRP assay plate, CRP calibrator, CRP detection antibody, CRP diluent and CRP read buffer. The assay in the MSD CRP Kit is a sandwich immunoassay employing electrochemiluminescence (ECL) detection. In the instrument, a voltage is applied to the plate electrodes causing the captured labels to emit light. The instrument measures the intensity of emitted light from each spot to provide a quantitative measure of analyte in the sample.
The document provided describes the MSD CRP Assay Kit and MESO SECTOR S 700 Instrument, an in vitro diagnostic device for quantitative determination of C-reactive protein (CRP) in human serum.
Here's the breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the successful completion of the studies according to CLSI guidelines, with results falling within acceptable statistical ranges. The document states, "All results for analytical performance met the sponsor's predetermined acceptance criteria for each study."
| Performance Characteristic | Acceptance Criteria (Implied by CLSI guidelines and sponsor's predetermined criteria) | Reported Device Performance (MSD CRP Assay Kit) |
|---|---|---|
| Precision/Reproducibility | Based on CLSI EP05-A3 guidelines, percentage coefficient of variation (%CV) within acceptable limits. | Total %CV: |
| Level 1 (4.45 mg/L): 7.3% | ||
| Level 2 (8.47 mg/L): 8.2% | ||
| Level 3 (10.81 mg/L): 7.1% | ||
| Level 4 (57.18 mg/L): 7.2% | ||
| Level 5 (215.8 mg/L): 8.3% | ||
| Linearity/Assay Reportable Range | Based on CLSI EP06-A guidelines. Linear regression analysis with high R² and acceptable slope/intercept. | Linear Range: 3 - 160 mg/L |
| Regression Analysis (0.627 – 201 mg/L): | ||
| Slope: 0.942 (95% CI: 0.926 – 0.958) | ||
| Intercept: 0.0296 (-0.0389 – 0.0982) | ||
| R²: 0.997 | ||
| % Recovery: -8.9% — 0.0% | ||
| Hook Effect | No prozone effect observed within the linear range. | No prozone effect observed up to 800 mg/L. |
| Traceability | Traceable to an international reference material. | Traceable to CRM474 reference material. |
| Stability | Demonstrates sufficient shelf life for the kit components. | Supports a kit shelf life of 7 months (real-time stability for un-opened components). |
| Limit of Blank (LoB) | Determined according to CLSI EP17-A2. | 0.02 mg/L for all tested kit lots. |
| Limit of Detection (LoD) | Determined according to CLSI EP17-A2. | 0.039, 0.048, and 0.049 mg/L for tested kit lots. |
| Limit of Quantification (LoQ) | Defined as the lowest concentration with Total Error (TE) |
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(260 days)
DCN
The C-Reactive Protein Kit for use on SPAPLUS is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This product is suitable for use on the SPAPLUS analyser.
The C-Reactive Protein Kit for use on SPAPLUS is comprised of the following reagents:
Antiserum: Supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, TRIS pH 8.0.
Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative. The concentration given on the quality control certificate has been obtained by comparison with the international reference standard ERM-DA474.
Reaction Buffer: Containing 0.099% sodium azide, TRIS pH 7.5 as preservatives.
The provided document is a 510(k) premarket notification for a C-Reactive Protein Kit for use on the SPAPLUS analyzer. It details the device's intended use, comparison to a predicate device, and performance characteristics.
Here’s a breakdown of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | ||
| Total precision | %CV |
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(238 days)
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The Hitachi Clinical Analyzer S TEST reagent cartridge CRP is intended for the quantitative measurement of C-reactive protein in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma. The test system is intended for use in clinical laboratories or physician office laboratories. CRP measurements aid in the evaluation of injury to body tissues, and infection and inflammatory disorders. For in vitro diagnostic use only.
The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available. The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) x 28 mm (D) x 20.2 mm (H). System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for reagent cartridge test systems for CRP. Chemistry reactions: CRP in samples causes an antigen-antibody reaction with latex sensitizes with Goat antihuman C-Reactive Protein antibody to induce agglutination. The concentration of CRP can be determined by measuring this agglutination as the amount of change in absorbance. CRP + Goat anti-human C-reactive protein antibody coated latex -> Agglutination due to antigen-antibody reaction
This document describes the Hitachi Clinical Analyzer S TEST Reagent Cartridge CRP, a device for measuring C-reactive protein.
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" but rather presents a series of performance studies with their results. I will infer typical acceptance ranges for these metrics based on common laboratory standards and the context of the predicate device.
| Performance Characteristic | Acceptance Criteria (Inferred) | Reported Device Performance (Hitachi Clinical Analyzer S TEST CRP) | Details |
|---|---|---|---|
| Analytical Sensitivity (Limit of Detection) | ≤1 mg/L (Matching predicate) | 0.7 mg/L | Meets/Exceeds criteria. |
| Linearity | 1 to 250 mg/L (Matching predicate) | 1 to 154 mg/L | The reported linearity of 1 to 154 mg/L is narrower than the predicate's 1 to 250 mg/L. This difference is noted in the comparison table but not further elaborated as a non-conformance. This suggests that the narrower range is acceptable for the intended use or that the upper range of the predicate is not strictly an acceptance criterion for the new device. |
| Precision (In-house) | Generally 0.975 for strong correlation, slopes close to 1, intercepts close to 0 (Inferred) | In-house: n=88, r=0.994, Slope=0.99 (0.96-1.01 CI), y-intercept=0.14 (-0.64-0.92 CI) | |
| Site 1: n=56, r=0.998, Slope=1.02 (1.00-1.04 CI), Intercept=0.1 (-0.5-0.6 CI) | |||
| Site 2: n=56, r=0.999, Slope=1.06 (1.05-1.08 CI), Intercept=-0.2 (-0.6-0.2 CI) | |||
| Site 3: n=55, r=0.998, Slope=1.03 (1.01-1.05 CI), Intercept=0.2 (-0.4-0.8 CI) | Meets criteria. High correlation coefficients (r) close to 1, slopes close to 1, and y-intercepts close to 0 indicate good agreement with the comparative methods. | ||
| Matrices Comparison | r-value >0.975 for strong correlation, slopes close to 1, intercepts close to 0 (Inferred) | Lithium Heparin Plasma: r=0.999, Slope=1.00 (0.98-1.01 CI), y-intercept=-0.12 (-0.75-0.52 CI) | |
| K3 EDTA Plasma: r=0.999, Slope=0.99 (0.97-1.00 CI), y-intercept=0.06 (-0.55-0.67 CI) | |||
| Na Citrate Plasma: r=0.999, Slope=1.00 (0.99-1.01 CI), y-intercept=-0.26 (-0.82-0.30 CI) | Meets criteria. High correlation and agreement with serum demonstrate suitability for various plasma types. | ||
| Precision (External POL sites) | Similar to in-house precision (Inferred) | Site 1: Low 6.6%, Mid 3.5%, High 5.6% | |
| Site 2: Low 14.1%, Mid 2.9%, High 7.1% | |||
| Site 3: Low 11.2%, Mid 3.9%, High 4.2% | Meets criteria, though Site 2 and Site 3 show slightly higher %CVs for low-level samples compared to Site 1, which is common in POL settings. Overall, these are within acceptable ranges for clinical use, particularly for a POL environment. |
Note regarding Acceptance Criteria: The document explicitly lists "no interference" for interference testing with a recovery range of 90-110%. For other metrics, the acceptance criteria are inferred based on the provided data, predicate device performance, and common regulatory expectations for in vitro diagnostic devices.
2. Sample Size Used for the Test Set and Data Provenance:
-
The document describes various studies, and the "test set" here refers to the samples used in these performance evaluations, rather than a specific validation test set for an AI algorithm.
- Analytical Sensitivity (Limits of Detection): Sample size not explicitly stated for this particular study, but the methodology followed CLSI EP17-A.
- Linearity: Sample size not explicitly stated for this particular study, but the methodology followed CLSI EP-6A. Range of linearity 1 to 154 mg/L was found.
- 20-day In-house Precision: Three levels of samples tested over 20 days. Each level was tested in two runs, twice a day. This implies 80 measurements per level (2 runs/day * 2 times/day * 20 days), but the summary tables show mean, SD, %CV for "Total" precision, suggesting consolidated results.
- Interference Testing: Two serum pools with approximately 12 mg/L and 80 mg/L C-reactive protein were used.
- Method Comparison (In-house): 88 clinical specimens.
- Matrices Comparisons: 45 matched serum/plasma samples.
- External Site Precision (Clinical Study): Three blinded serum samples (low, middle, high CRP concentrations) were assayed six times per day for five days at each of three sites, resulting in 30 replicates per level per site.
- Method Comparison (Clinical Study - POL Sites): Approximately 55 serum specimens (56 for Sites 1 & 2, 55 for Site 3).
-
Data Provenance: The document does not explicitly state the country of origin for the clinical or non-clinical samples. However, the external studies were conducted at "three external POL-type sites," implying a clinical setting within the United States market for which the device is being cleared. The method comparison refers to "clinical specimens." The studies are retrospective in the sense that they use collected samples to establish performance characteristics for the device itself rather than following a patient cohort prospectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This device is an in vitro diagnostic (IVD) test for quantitative measurement of C-reactive protein. For such devices, "ground truth" is typically established by:
- Reference methods (e.g., a "standard laboratory system" or "comparative method" mentioned in the document).
- Certified reference materials.
- Highly qualified laboratory personnel following standardized protocols.
The document does not mention the use of experts in the traditional sense of medical image interpretation (e.g., radiologists) to establish ground truth for this type of chemical assay. The "ground truth" for the method comparison studies was derived from a "standard laboratory system" or a "comparative method," which would be another FDA-cleared or gold-standard CRP assay administered by qualified laboratory professionals. The qualifications of these professionals are not detailed, but it's understood they would be trained lab technicians/scientists.
4. Adjudication Method for the Test Set:
Not applicable. As this is a quantitative in vitro diagnostic assay, there is no "adjudication method" in the sense of multiple human readers resolving disagreements. Performance is determined by comparing the device's quantitative output against either a reference method's quantitative output or known concentrations in control materials.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. This device is an in vitro diagnostic assay measuring C-reactive protein, not a medical imaging AI device involving human readers. There is no AI component or human-in-the-loop performance described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is an automated in vitro diagnostic instrument with reagent cartridges. Its performance is inherently "standalone" in the sense that it performs a chemical analysis and provides a quantitative result without human interpretive input beyond sample loading and result review. There is no separate "algorithm" for distinct standalone performance that would typically be distinguished from a human-in-the-loop scenario. The performance metrics presented (precision, linearity, method comparison) are its standalone performance.
7. The Type of Ground Truth Used:
The ground truth for the device's performance claims was established through:
- Reference methods: For method comparison studies, the Hitachi system's results were compared against an "standard laboratory system" (in-house validation) or a "comparative method" (external POL validation). These reference methods serve as the de-facto ground truth for assessing performance.
- Known concentrations: For studies like linearity, analytical sensitivity, and precision, samples with known or well-characterized concentrations of CRP (e.g., control materials, spiked samples, reference materials) are used.
- Certified protocols: The studies followed established clinical laboratory standards (CLSI guidelines: EP17-A, EP-6A, EP5-A2, EP7-A2, EP9-A2), which dictate how ground truth is appropriately established for these types of assays.
8. The Sample Size for the Training Set:
Not applicable. This device is a diagnostic assay, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The device's operational parameters and performance were likely optimized during its development using various samples, but these are not referred to as a "training set" in this context. The "nonclinical data" and "clinical data" sections describe validation studies, not training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable (as there is no "training set" in the AI/ML context). As described in point #7, ground truth for the performance evaluation was established using reference laboratory methods, known concentrations, and adherence to CLSI guidelines.
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(277 days)
DCN
The Piccolo® C-Reactive Protein Test System used with the Piccolo xpress™ Chemistry Analyzer is intended to be used for the in vitro quantitative determination of CRP concentration in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point of care location. This test is not intended for high sensitivity CRP measurement.
C-Reactive Protein test results aid in the evaluation of infection, tissue injury, and inflammatory disorders in conjunction with other laboratory and clinical findings.
The Piccolo MetLyte Plus CRP Reagent Disc (which contains the Piccolo C-Reactive Protein Test System) is designed for lithium heparinized whole blood, lithium heparinized plasma, and serum, only. The disc meters the required quantity of sample and diluent, mixes the sample with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted sample mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.
This document describes the Abaxis Piccolo C-Reactive Protein (CRP) Test System and demonstrates its substantial equivalence to a legally marketed predicate device (Beckman Synchron LX20 Chemistry System K070626). The information provided focuses on the performance characteristics of the Abaxis device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" for linearity or precision in a numerical format that would represent target values. Instead, it presents the results of linearity and precision studies. The implicit acceptance is that these results demonstrate performance comparable to clinical expectations for such a device and are sufficient to prove substantial equivalence to the predicate device.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Abaxis Piccolo CRP Test System) |
|---|---|---|
| Linearity | Demonstrate a strong linear relationship across the assay range. | Slope: 1.037 |
| Intercept: -0.764 | ||
| Correlation Coefficient: 0.997 | ||
| Precision (Within-Run & Total) | Demonstrate acceptable repeatability and reproducibility for different CRP levels in serum and plasma. | C-Reactive Protein (mg/L) |
| Serum Level 1 (n=80) | ||
| Mean: 8.3, SD: 0.70 (Within-Run), 0.81 (Total), %CV: 8.4 (Within-Run), 9.8 (Total) | ||
| Serum Level 2 (n=40) | ||
| Mean: 8.1, SD: 0.49 (Within-Run), 0.51 (Total), %CV: 6.1 (Within-Run), 6.3 (Total) | ||
| Serum Level 3 (n=40) | ||
| Mean: 8.8, SD: 0.54 (Within-Run), 0.54 (Total), %CV: 6.2 (Within-Run), 6.2 (Total) | ||
| Plasma 1 (n=40) | ||
| Mean: 34.5, SD: 1.04 (Within-Run), 1.09 (Total), %CV: 3.0 (Within-Run), 3.2 (Total) | ||
| Plasma 2 (n=40) | ||
| Mean: 105.5, SD: 2.06 (Within-Run), 2.30 (Total), %CV: 1.9 (Within-Run), 2.2 (Total) | ||
| Control Level 1 (n=80) | ||
| Mean: 33.0, SD: 1.21 (Within-Run), 2.12 (Total), %CV: 3.7 (Within-Run), 6.4 (Total) | ||
| Control Level 2 (n=80) | ||
| Mean: 108.0, SD: 1.88 (Within-Run), 3.14 (Total), %CV: 1.7 (Within-Run), 2.9 (Total) | ||
| Sample Type Comparability | Demonstrate comparable results across lithium heparinized whole blood, lithium heparinized plasma, and serum. | Comparability was established for CRP. |
Study Proving Device Meets Criteria:
The study conducted to prove the device meets these criteria is a series of clinical and non-clinical tests summarized in Tables 2 and 3 and described under Section 7: "Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence."
2. Sample Size Used for the Test Set and Data Provenance:
- Linearity Study: The sample size for the linearity study is not explicitly stated in terms of number of patient samples. It reports a slope, intercept, and correlation coefficient, which are derived from a series of measurements across a range of concentrations.
- Precision Studies:
- Serum Level 1: n = 80
- Serum Level 2: n = 40
- Serum Level 3: n = 40
- Plasma 1: n = 40
- Plasma 2: n = 40
- Control Level 1: n = 80
- Control Level 2: n = 80
- Sample Type Comparison Study: The document states "A study was conducted to examine and compare results for lithium heparinized whole blood, lithium heparinized plasma, and serum," but does not explicitly provide the number of samples used in this comparison.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a clinical laboratory test system, such studies are typically prospective analytical validation studies using prepared samples or patient samples collected for the purpose of the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. For an invitro diagnostic (IVD) device like a CRP test, "ground truth" is typically established by reference methods or validated comparative methods ("predicate device" in this case) rather than by expert consensus on qualitative interpretation. The "ground truth" for the test set is considered to be the quantitative values obtained from a reference method or the predicate device.
4. Adjudication Method for the Test Set:
This information is not applicable/provided for this type of IVD device. Adjudication methods (like 2+1, 3+1) are common in studies involving expert interpretation of images or other subjective data. For a quantitative test like CRP, the "adjudication" is essentially the comparison of results against a reference method or the predicate device with predefined statistical measures.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, a MRMC comparative effectiveness study was not done. MRMC studies are typically performed for devices that involve human interpretation (e.g., radiologists reading images) to assess the impact of a device on reader performance. This document concerns a fully automated quantitative test system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Yes, a standalone performance evaluation was done. The document focuses exclusively on the analytical performance of the "Piccolo C-Reactive Protein Test System" run on the "Piccolo xpress Chemistry Analyzer" (an automated system). The precision and linearity data presented directly reflect the performance of the device without human interpretation affecting the result. The comparison is between the new device and a predicate device, both being automated quantitative systems.
7. The Type of Ground Truth Used:
The ground truth used for this type of quantitative IVD device is generally based on:
- Comparison to a legally marketed predicate device: The document explicitly states the "Piccolo C-Reactive Protein Test System" is compared to the "Beckman Synchron LX20 Chemistry System K070626". The performance characteristics (e.g., linearity, precision) are evaluated using samples for which the CRP concentration is known or reliably determined by established methods or the predicate device.
- Reference materials/methods: Implicitly, the linearity and precision studies would rely on samples with known or traceable CRP concentrations, potentially established using reference materials or highly accurate reference methods, to assess the accuracy of the device across its measuring range.
8. The Sample Size for the Training Set:
The document does not provide information regarding a "training set" or its sample size. This is typical for analytical validation reports of IVD devices for 510(k) submissions, which focus on analytical performance testing rather than machine learning model development. The device itself is an immunoassay system, not an AI/ML algorithm that requires a separate training set.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" in the context of an AI/ML model, this question is not applicable to the provided document. The "ground truth" for the analytical performance studies (linearity, precision) would be established by reference methods or the performance of the predicate device, as mentioned in point 7.
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Immunoturbidometric assay for the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.
Measurement of c-reactive protein aids in the evaluation of the amount of injury to body tissues.
The C-Reactive Protein Gen 3 assay is a particle enhanced turbidimetric assay. Human CRP agglutinates with latex particles coated with monoclonal anti-CRP antibodies. The precipitate is determined turbidimetrically at 570 nm.
Here's a breakdown of the acceptance criteria and study information for the Tina-Quant C-Reactive Protein Gen. 3 device, based on the provided text:
Acceptance Criteria and Device Performance
The provided document describes modifications to an existing device (Tina-Quant C-Reactive Protein Gen 3) and claims substantial equivalence to its predicate device (Tina-Quant C-Reactive Protein (Latex), K032336). Therefore, the acceptance criteria are implicitly defined by demonstrating comparable core performance characteristics to the predicate device. The information below presents the modified device's performance alongside the predicate's performance for comparison, which serves as the "acceptance criteria" through the lens of substantial equivalence.
Table of Acceptance Criteria (Predicate Performance) and Reported Device Performance (Modified Device)
| Feature | Acceptance Criteria (Predicate Device Performance - K032336) | Reported Device Performance (Modified Device - K082444) |
|---|---|---|
| Measuring Range | Roche/Hitachi 902: 1-265 mg/L | |
| Roche/Hitachi 717/Modular D: 1-265 mg/L, 1-398 mg/L with rerun | ||
| Roche/Hitachi 904/911/912: 1-260 mg/L, 1-520 mg/L with rerun | ||
| Roche/Hitachi 917/Modular P: 1-280 mg/L, 1-560 mg/L with rerun | Roche/Hitachi 901/912/917/Modular P/Modular D analyzers: 0.3-350 mg/L. Dilution of samples via the rerun function is a 1:2 dilution. | |
| Precision (Within Run) | Control 1: Mean (mg/L) 3.36, SD (mg/L) 0.09, %CV 2.76 | |
| Control 2: Mean (mg/L) 22.17, SD (mg/L) 0.44, %CV 1.96 | ||
| Control 3: Mean (mg/L) 51.12, SD (mg/L) 0.90, %CV 1.77 | ||
| H Pool 1: Mean (mg/L) 5.76, SD (mg/L) 0.14, %CV 2.50 | ||
| H Pool 2: Mean (mg/L) 150.15, SD (mg/L) 1.14, %CV 0.76 | Control 1: Mean (mg/L) 3.6, SD (mg/L) 0.03, %CV 0.85 | |
| Control 2: Mean (mg/L) 42.2, SD (mg/L) 0.26, %CV 0.61 | ||
| H Pool 1: Mean (mg/L) 0.9, SD (mg/L) 0.03, %CV 4.00 | ||
| H Pool 2: Mean (mg/L) 1.6, SD (mg/L) 0.02, %CV 1.02 | ||
| H Pool 3: Mean (mg/L) 18.4, SD (mg/L) 0.09, %CV 0.48 | ||
| Precision (Between Run) | Control 1: Mean (mg/L) 3.51, SD (mg/L) 0.16, %CV 4.61 | |
| Control 2: Mean (mg/L) 22.01, SD (mg/L) 0.62, %CV 2.81 | ||
| Control 3: Mean (mg/L) 50.41, SD (mg/L) 0.94, %CV 1.86 | ||
| H Pool 1: Mean (mg/L) 5.99, SD (mg/L) 0.15, %CV 2.53 | ||
| H Pool 2: Mean (mg/L) 146.31, SD (mg/L) 2.63, %CV 1.80 | Control 1: Mean (mg/L) 3.1, SD (mg/L) 0.08, %CV 2.7 | |
| Control 2: Mean (mg/L) 41.4, SD (mg/L) 0.86, %CV 2.1 | ||
| H Pool 1: Mean (mg/L) 0.5, SD (mg/L) 0.03, %CV 6.2 | ||
| H Pool 2: Mean (mg/L) 1.5, SD (mg/L) 0.05, %CV 3.3 | ||
| H Pool 3: Mean (mg/L) 39.1, SD (mg/L) 0.73, %CV 1.9 | ||
| Analytical Sensitivity | Functional Sensitivity: 0.88 mg/L | |
| Lower Detection Limit: 0.425 mg/L | Limit of Quantitation (Functional Sensitivity): 0.6 mg/L | |
| LoB: 0.2 mg/L | ||
| LoD: 0.3 mg/L | ||
| Interferences | Icterus: No significant interference up to 60 mg/dL | |
| Hemolysis: No significant interference up to 950 mg/dL | ||
| Lipemia: No significant interference up to L index of 1700 | ||
| Rheumatoid Factor: No interference up to 1200 IU/mL | ||
| High dose hook effect: No false results up to CRP concentrations of 1200 mg/L | Icterus: same (implicitly up to 60 mg/dL) | |
| Hemolysis: No significant interference up to 1000 mg/dL | ||
| Lipemia: No significant interference up to L index of 1000 | ||
| Rheumatoid Factor: same (implicitly up to 1200 IU/mL) | ||
| High dose hook effect: same (implicitly up to 1200 mg/L) | ||
| Method Comparison | Slope (Passing Bablok): 1.020 | |
| Intercept: 0.000 | ||
| Coefficients of correlation (r): 1.000 | Comparison was performed against Tina-Quant C-Reactive Protein (latex) on Hitachi 917. Specific numerical results (slope, intercept, correlation coefficient) for the modified device against the predicate are not provided in this section, but the predicate's values are listed as the reference, implying the modified device aims to match these. |
Study Information
The provided document describes a Special 510(k): Device Modification submission for the Tina-Quant C-Reactive Protein Gen 3 assay. The core of the "study" is a comparison of the modified device's performance characteristics against its predicate device (Tina-Quant C-Reactive Protein (Latex), K032336), to demonstrate substantial equivalence.
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not explicitly state the specific number of samples used for each test (e.g., precision, interference, method comparison). For the "Method Comparison," it refers to a "Scatter plot showing correlation between two methods for measuring C-Reactive Protein," which implies a collection of patient or control samples were run on both methods. However, the exact count is not given.
- Data Provenance: Not explicitly stated. The studies were conducted by Roche Diagnostics, suggesting internal studies. The country of origin of the data is not mentioned, nor is whether the data was retrospective or prospective.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is an in vitro diagnostic (IVD) device for quantitative determination of CRP. For such devices, "ground truth" is typically established by reference methods or highly accurate analytical techniques, not by expert consensus on interpretations like with imaging. The document traces the device's standardization to CRM 470, which is a certified reference material for proteins. There is no mention of experts establishing a ground truth in the context of clinical interpretation, as this device provides a quantitative measurement.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is an IVD device for quantitative measurement. Adjudication methods like "2+1" typically apply to diagnostic tasks involving human interpretation or subjective assessments, where disagreements between experts need to be resolved.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is an automated in vitro diagnostic assay, not a device that assists human readers (like AI for image analysis). Therefore, comparisons of human reader performance with or without AI assistance are not relevant to this submission.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, effectively, this is a standalone device performance evaluation. The device is an automated clinical chemistry analyzer that quantitatively measures CRP. The performance metrics reported (precision, analytical sensitivity, interference, method comparison) are intrinsic to the device's analytical function without direct human intervention in the result generation process, beyond sample loading and general operation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Reference material standardization. The device claims traceability to CRM 470 for standardization. This implies that the "ground truth" for the quantitative CRP measurements is established against this internationally recognized reference material, rather than clinical outcomes, pathology, or expert consensus on a diagnostic interpretation.
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The sample size for the training set:
- Not applicable. This document is for a device modification of an in vitro diagnostic assay, not an AI/ML algorithm. Therefore, there isn't a "training set" in the sense of data used to train a machine learning model. The assay's parameters would have been developed and optimized through laboratory experiments, but the concept of a "training set" as commonly understood in AI/ML is not directly relevant here.
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How the ground truth for the training set was established:
- Not applicable. As explained above, there is no "training set" for an AI/ML algorithm. For the initial development and optimization of the assay reagents and methods, ground truth for measuring CRP would typically be established using highly characterized samples with known CRP concentrations (e.g., purified CRP, reference materials like CRM 470, or validated high-accuracy laboratory methods).
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