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510(k) Data Aggregation
(39 days)
K961481/A003
Immunoassay for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers. Elecsys PTH CalSet STAT is used for calibrating the quantitative Elecsys PTH STAT assay for intact PTH (parathyroid hormone) on the Elecsys and cobas e immunoassay analyzers. Elecsys PTH CalSet is used for calibrating the quantitative Elecsys PTH assay for intact PTH (parathyroid hormone) on the Elecsys and cobas e immunoassay analyzers
(1) The Elecsys PTH STAT Assay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code. (2) The Elecsys PTH STAT CalSet is a lyophilized product consisting of human serum with added synthetic PTH in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The Elecsys PTH Test System is an immunoassay device for the quantitative determination of intact parathyroid hormone in human serum and plasma, used for the differential diagnosis of hypercalcemia and hypocalcemia. The information provided outlines the device's characteristics and compares it to a predicate device to establish substantial equivalence, rather than detailing a study focused on acceptance criteria. Therefore, most of the requested information regarding study details, sample sizes, expert involvement, and ground truth establishment cannot be extracted directly from the provided text for this device.
However, based on the comparison provided, we can infer some performance characteristics that serve as "acceptance criteria" through comparison to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Acceptance Criteria (as implied by predicate comparison) | Predicate Device (Elecsys PTH Assay) Performance | Modified Device (Elecsys PTH STAT) Performance |
|---|---|---|
| Intended Use | Immunoassay for in vitro quantitative determination of intact PTH in human serum and plasma for differential diagnosis of hypercalcemia and hypocalcemia. | Same |
| Assay Protocol | Sandwich assay | Same |
| Detection Method | Electrochemiluminescent | Same |
| Sample Type | Human serum and plasma treated with K3-EDTA | Same |
| Calibrator Name | Elecsys PTH CalSet | Elecsys PTH STAT CalSet |
| Calibrator Levels | Two | Same |
| Measuring Range | 1.20 – 5,000 pg/mL | Same |
| Analytical Sensitivity | 1.20 pg/mL (0.127 pmol/L) | Same |
| Calibrator Matrix | Human serum w/ synthetic PTH | Same |
| Calibrator Storage | Lyophilized | Same |
| Calibrator Target Concentrations | Cal 1: ~0.05 pg/mL, Cal 2: ~4500 pg/mL | Same |
| Traceability/Standardization | Standardized against a commercially available PTH test (RIA). | Standardized against Elecsys PTH (Cat. No. 11972103), which was standardized against a commercial PTH test (RIA). |
| Hook Effect | No high dose hook effect up to 17,000 pg/mL | Same |
| Analytical Specificity | No cross-reactivity with Osteocalcin, PTH fragment 1-37, bone-specific alkaline phosphatase, and β-Crosslaps. | Same (reworded for clarity) |
| Opened Reagent Stability (Elecsys 2010/cobas e 411) | 8 weeks | 8 weeks |
| Opened Reagent Stability (Elecsys 1010) | 4 weeks | 4 weeks |
| Calibration Interval (same reagent lot, Elecsys 2010/cobas e 411) | After 1 month (28 days) | After 1 month (28 days) |
| Calibration Interval (same reagent kit, Elecsys 2010/cobas e 411) | After 7 days | After 7 days |
| Calibration Interval (Elecsys 1010) | With every reagent kit, After 7 days (20-25°C), After 3 days (25-32°C) | With every reagent kit, After 7 days (20-25°C), After 3 days (25-32°C) |
| Precision (Within-run, Elecsys 2010/cobas e411) | N/A (different values reported for predicate. See below for relevant predicate precision values) | 2.1% CV @ 53.4 pg/mL, 1.7% CV @ 215 pg/mL, 1.7% CV @ 980 pg/mL, 1.6% CV @ 52.6 pg/mL, 2.0% CV @ 182 pg/mL, 1.8% CV @ 744 pg/mL |
| Precision (Total, Elecsys 2010/cobas e411) | N/A (different values reported for predicate. See below for relevant predicate precision values) | 3.8% CV @ 53.4 pg/mL, 2.8% CV @ 215 pg/mL, 2.5% CV @ 980 pg/mL, 1.9% CV @ 52.6 pg/mL, 2.5% CV @ 182 pg/mL, 2.2% CV @ 744 pg/mL |
| Limitations (Hemolysis) | Hemolysis (Hb |
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(90 days)
The Olympus thyroid stimulating hormone (TSH) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of TSH levels in human serum and plasma using the Olympus AU3000i™ Immunoassay System.
Measurements of TSH produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The Olympus TSH Calibrator is used for calibrating the quantitative Olympus TSH Assay on the Olympus AU3000i Immunoassay System.
The Olympus TSH Control is used for quality control of the Olympus TSH test system on the Olympus AU3000i Immunoassay System.
The Olympus AU3000i Immunoassay System is a chemiluminescent discrete photometric chemistry analyzer for the quantitative determination of analytes in human serum and plasma.
The Olympus TSH assay is a two-step paramagnetic particle enzyme immunoassay. It is based on the sandwich principle and used to quantitate TSH in serum/plasma.
The Olympus TSH assay reagent and sample are added to the assay cuvette in the following sequence:
- Samples are incubated first with a monoclonal anti-TSH antibody bound to paramagnetic particles.
- After a washing step, a second monoclonal anti-TSH antibody conjugated with alkaline phosphatase is added. The TSH reacts with the paramagnetic particles and the conjugated antibody to form a sandwich complex. Washing steps remove the unbound material.
- The chemiluminescent substrate is added to the assay cuvette and reacts with the bound alkaline phosphatase (ALP). Light generated by the reaction is measured by the luminometer. The light emission is proportional to the quantity of TSH in the sample.
- Results are calculated from a pre-defined calibration curve. The Olympus AU3000i system automatically calculates the TSH concentration of each sample in mIU/L or µIU/mL.
The provided 510(k) summary focuses on demonstrating substantial equivalence of the Olympus TSH Test System to predicate devices rather than establishing novel acceptance criteria and proving the device meets them with a dedicated study. Instead, the performance characteristics of the Olympus TSH Test System are compared directly to those of the predicate Roche Elecsys® TSH Test System.
Therefore, the response below will present the performance characteristics as a comparison to the predicate device, rather than explicit "acceptance criteria" and "reported device performance."
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission demonstrating substantial equivalence, explicit "acceptance criteria" are not stated in the typical sense of a performance goal. Instead, the performance of the Olympus TSH Test System is compared directly to the predicate device, the Roche Elecsys® TSH Test System. The implicit acceptance criterion is that the performance of the new device is comparable to the predicate.
| Performance Characteristic | Predicate Device Performance (Roche Elecsys® TSH) | Olympus TSH Test System Performance |
|---|---|---|
| Precision (Total CV%) | ||
| Low Concentration | 8.7 | 2.9 |
| Medium Concentration | 3.3 | 6.0 |
| High Concentration | 3.6 | 3.7 |
| Functional Sensitivity | 0.014 µIU/mL | 0.0013 µIU/mL |
| Analytical Sensitivity | 0.005 µIU/mL | 0.0002 µIU/mL |
| Measurable Range | 0.005 – 100.0 µIU/mL | 0.001 – 130 µIU/mL |
| Method Comparison (Passing Bablok) | ||
| Intercept | 0.01 | -0.0046 |
| Slope | 1.01 | 0.935 |
| R | 0.944 | 0.9931 |
| Applicable Interfering Substances | ||
| Bilirubin | ≤ 10% @ 41 mg/dL | ≤ 10% @ 40 mg/dL |
| Hemolysis | ≤ 10% @ 1 g/dL | ≤ 5% @ 5 g/L |
| Lipemia | ≤ 10% @ 1500 mg/dL | ≤ 3% @ 10 g/L |
| Specificity (LH, FSH, hGH, hCG) | No significant interference for LH & FSH. hGH Not Detected. hCG Not Detected. | No significant interference for LH & FSH. hGH Not Tested. hCG Not Detected. |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the performance characteristic studies (e.g., precision, method comparison, interference). The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.
3. Number of Experts and Qualifications for Ground Truth
For in vitro diagnostic (IVD) devices like the Olympus TSH Test System, "ground truth" is typically established through reference methods, certified calibrators, or established analytical techniques, rather than expert human interpretation (like radiologists). The document indicates traceability to "WHO" (World Health Organization) for both the predicate and proposed device, implying the use of international reference standards. No human experts are mentioned for establishing ground truth.
4. Adjudication Method for the Test Set
Not applicable for an IVD device where ground truth is typically assessed through quantitative analytical methods and reference standards, not human adjudication of subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is an in vitro diagnostic device for quantitative determination of TSH levels, not an imaging or diagnostic aid for human readers.
6. Standalone Performance Study
Yes, the performance characteristics listed in the table above (Precision, Functional Sensitivity, Analytical Sensitivity, Measurable Range, Method Comparison, Interference, Specificity) represent the standalone (algorithm/device only) performance of the Olympus TSH Test System. These are intrinsic analytical performance metrics of the device itself.
7. Type of Ground Truth Used
The ground truth for this type of IVD device is based on reference materials, certified calibrators, and/or comparison to a well-established and accepted reference method. The document states "Traceability: WHO" for both the Olympus TSH Test System (WHO 3rd IS 81/565) and the predicate (WHO 2nd IRP 80/558), indicating that the results are standardized against internationally recognized standards for TSH measurement.
8. Sample Size for the Training Set
The document does not specify a separate "training set" sample size. For IVD devices, method development and optimization studies are conducted, but usually, a distinct "training set" and "test set" in the context of machine learning (where this terminology is common) are not explicitly detailed in 510(k) summaries for traditional immunoassay systems. The performance characteristics described are typically derived from verification and validation studies.
9. How Ground Truth for the Training Set Was Established
Not explicitly detailed as a "training set" in the machine learning sense. However, for the development and calibration of such an assay, ground truth would be established through a combination of:
- Using calibrators with known TSH concentrations (e.g., Olympus TSH Calibrator, referenced to WHO standards).
- Testing against reference samples or patient samples analyzed by established, validated reference methods, often traceable to international standards.
- The "Olympus TSH Calibrator is used for calibrating the quantitative Olympus TSH Assay," and its matrix is "Bovine serum human pituitary TSH," implying that the calibrators themselves embody the "ground truth" for the device's measurement scale.
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(20 days)
K961481/A003
Binding assay for the in vitro quantitative determination of vitamin B12 in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.
A Vitamin B12 test system is a device intended to measure Vitamin B12 in serum, plasma. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
Elecsys Vitamin B12 CalSet II is used for calibrating the quantitative Elecsys Vitamin B12 assay on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.
For use in the verification of the calibration established by the Elecsys Vitamin B12 reagent on Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.
(1) The Elecsys Vitamin B12 Assay employs a competitive test principle using intrinsic factor specific for Vitamin B12. Vitamin B12 in the sample competes with the added Vitamin B12 labeled with biotin for the binding sites on the ruthenium-labeled intrinsic factor complex. 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.
(2) The Elecsys Vitamin B12 CalSet II is a lyophilized product consisting of human serum with added Vitamin B12 in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
(3) The Elecsys Vitamin B12 CalCheck is a lyophilized product consisting of human serum with added Vitamin B12. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The provided document describes the Elecsys Vitamin B12 Test System, which includes the Elecsys Vitamin B12 Immunoassay, Elecsys Vitamin B12 CalSet II, and Elecsys Vitamin B12 CalCheck. This system is intended for the in vitro quantitative determination of Vitamin B12 in human serum and plasma, used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
The document is a 510(k) Premarket Notification summary, seeking substantial equivalence to previously cleared devices. It primarily focuses on comparing the new device (modified device) to its predicates and detailing the differences and similarities. It does not explicitly state pre-defined acceptance criteria for the modified device's performance, nor does it present a study designed to explicitly prove the device meets such acceptance criteria as a primary outcome.
Instead, the document presents analytical performance data (precision and method comparison) for the modified device and compares it to the predicate device. The goal of this submission is to demonstrate that the changes implemented do not raise new questions of safety and effectiveness, and that the modified device remains substantially equivalent to the predicate.
Given this, I will extract the available performance data and structure the answer to reflect what is present in the document. Since explicit acceptance criteria are not provided for the modified device in the context of a new study to prove "acceptance," I will highlight the reported performance parameters and the context of their presentation (comparison to predicate).
1. Table of Acceptance Criteria and Reported Device Performance
As explicit acceptance criteria for the modified device are not stated in the provided text, the table below presents the reported performance of the modified device alongside that of the predicate device for comparison. The underlying assumption in a 510(k) submission for modifications is that the modified device's performance should be comparable to or better than the predicate, or that any differences do not negatively impact safety and effectiveness.
| Performance Characteristic | Acceptance Criteria (Implicit for 510(k) Substantial Equivalence - generally comparable to predicate) | Elecsys Vitamin B12 (Modified Device) Performance | Elecsys Vitamin B12 (Predicate Device K973702) Performance |
|---|---|---|---|
| Precision (Within-Run) | |||
| Elecsys 2010 | Comparable to Predicate | HS 1: 8.7% (232 pg/mL); HS 2: 4.4% (818 pg/mL); HS 3: 3.0% (1,245 pg/mL) | Human Serum 1: 6.9% (203 pg/mL); Human Serum 2: 4.2% (481 pg/mL); Human Serum 3: 2.7% (1,499 pg/mL) |
| PCA 1: 8.3% (226 pg/mL); PCA 2: 4.0% (610 pg/mL); PCA 3: 3.1% (1,369 pg/mL) | Control 1: 2.8% (1,119 pg/mL); Control 2: 4.3% (471 pg/mL) | ||
| MODULAR ANALYTICS E170 | Comparable to Predicate | HS 1: 1.2% (267 pg/mL); HS 2: 2.9% (887 pg/mL); HS 3: 1.5% (1,308 pg/mL) | Human Serum 1: 2.4% (155 pg/mL); Human Serum 2: 2.8% (359 pg/mL); Human Serum 3: 0.6% (1,162 pg/mL) |
| PCA 1: 1.7% (308 pg/mL); PCA 2: 1.0% (710 pg/mL); PCA 3: 0.8% (1,524 pg/mL) | PreciControl U1: 0.9% (667 pg/mL); PreciControl U2: 4.3% (399 pg/mL) | ||
| Precision (Total) | |||
| Elecsys 2010 | Comparable to Predicate | HS 1: 9.5% (232 pg/mL); HS 2: 5.1% (818 pg/mL); HS 3: 3.7% (1,245 pg/mL) | Human Serum 1: 7.6% (203 pg/mL); Human Serum 2: 4.4% (481 pg/mL); Human Serum 3: 3.2% (1,499 pg/mL) |
| PCA 1: 8.0% (226 pg/mL); PCA 2: 5.2% (610 pg/mL); PCA 3: 3.4% (1,369 pg/mL) | Control 1: 3.2% (1,119 pg/mL); Control 2: 4.6% (471 pg/mL) | ||
| MODULAR ANALYTICS E170 | Comparable to Predicate | HS 1: 8.4% (269 pg/mL); HS 2: 3.3% (853 pg/mL); HS 3: 2.5% (1,261 pg/mL) | Human Serum 1: 6.1% (157 pg/mL); Human Serum 2: 3.6% (349 pg/mL); Human Serum 3: 2.2% (1,128 pg/mL) |
| PCA 1: 7.5% (239 pg/mL); PCA 2: 3.7% (658 pg/mL); PCA 3: 2.4% (1,415 pg/mL) | PreciControl 1: 2.8% (671 pg/mL); PreciControl 2: 4.2% (391 pg/mL) | ||
| Method Comparison | |||
| Predicate vs. Commercially available radiobinding assay | N/A | N/A | N = 345, Passing Bablok: y = -9.2 + 1.06x, r = 0.977, SD(md68) = 45.7; Linear regression: y = 7.4 + 1.02x, r = 0.977, Sy.x = 75.5. Range: 30 - 1,798 pg/mL |
| Modified Device (E170 w/ CalSet II) vs. Predicate (E170 w/ CalSet) | Comparable to Predicate method comparison results (e.g., strong correlation, desirable slope/intercept) | N = 101, Passing Bablok: y = 0.982x - 0.018, r = 0.977, SD(md68) = 8.05; Linear regression: y = 0.968x + 5.77, r = 0.999, Sy.x = 9.63. Range: 49 - 1,691 pg/mL | N/A |
Note on "Acceptance Criteria": This 510(k) submission is for a modified device demonstrating substantial equivalence. The "acceptance criteria" for such a submission are typically implicit: the modified device's performance data (precision, method comparison, etc.) should demonstrate that the changes do not adversely affect the device's safety and effectiveness compared to the predicate, and that the device performs as intended within clinically acceptable limits. Explicit numerical acceptance criteria are not presented in this summary.
2. Sample Size Used for the Test Set and Data Provenance
-
Precision Study:
- The sample sizes for the human serum samples and controls are not explicitly stated as a single "test set" number for the precision study. Instead, the results are presented for multiple individual samples (HS 1, HS 2, HS 3, PCA 1, PCA 2, PCA 3 for the modified device; Human Serum 1, 2, 3, Control 1, 2 for the predicate) each run multiple times to determine within-run and total precision (CV%). The number of replicates is not specified.
- Data Provenance: Not explicitly stated (e.g., country of origin). It is a laboratory study to assess analytical performance.
- Retrospective/Prospective: Not specified, but analytical performance studies like precision are typically conducted prospectively.
-
Method Comparison Study:
- Modified Device Study Sample Size: N = 101 (comparison of MODULAR ANALYTICS E170 calibrated with Elecsys Vitamin B12 CalSet II vs. E170 calibrated with Elecsys Vitamin B12 CalSet).
- Predicate Device Study Sample Size: N = 345 (comparison of Elecsys Vitamin B12 with a commercially available radiobinding Vitamin B12 assay).
- Data Provenance: Not explicitly stated (e.g., country of origin).
- Retrospective/Prospective: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of submission (for an in vitro diagnostic assay) does not typically involve "experts to establish ground truth" in the same way imaging or clinical decision support AI devices do. The "ground truth" for Vitamin B12 assays is the actual concentration of Vitamin B12 in the samples. For method comparison, an existing, accepted method (predicate device or another commercially available assay) serves as the reference. Therefore, this section is not applicable in the context of this device and study type.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is an analytical performance study for an in vitro diagnostic, not a study involving human interpretation with 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 performed. This type of study is relevant for imaging devices or AI tools that assist human readers in interpretation. The Elecsys Vitamin B12 Test System is an automated in vitro diagnostic assay.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, the studies presented (precision and method comparison) are essentially "standalone" performance evaluations of the assay system itself. The assay is an automated electrochemiluminescence immunoassay (ECLIA) run on Roche Elecsys 2010 and MODULAR ANALYTICS E170 analyzers. Its output is a quantitative measurement of Vitamin B12, not a diagnostic interpretation that requires human-in-the-loop interaction for its primary function.
7. The Type of Ground Truth Used
The "ground truth" for the performance studies shown is:
- Precision: The inherent value of the assayed samples (human serum and controls) determined by repetitive measurements.
- Method Comparison: Values obtained from a previously cleared or commercially available (reference) Vitamin B12 assay. For the modified device, the predicate device calibrated with the original CalSet serves as the reference for method comparison with the modified device using CalSet II.
8. The Sample Size for the Training Set
This information is not provided in the document. This submission describes an in vitro diagnostic device, not a machine learning or AI algorithm that typically has a distinct training set. The "training" for a device like this would involve calibration procedures using specific calibrators (Elecsys Vitamin B12 CalSet II) and master curves, often established during development and manufacturing, rather than a "training set" of patient data in the AI sense.
9. How the Ground Truth for the Training Set was Established
As noted above, this device does not have a "training set" in the context of machine learning. The "ground truth" for instrument calibration is established by using calibrators (Elecsys Vitamin B12 CalSet II) which are "lyophilized product[s] consisting of human serum with added Vitamin B12." These calibrators "are used for calibrating the quantitative Elecsys Vitamin B12 assay." The concentrations of Vitamin B12 in these calibrators are determined during manufacturing and are traceable to a standardization process, which for the modified device is "standardized against the Elecsys Vitamin B12 assay."
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