Search Results

For in vitro diagnostic use only.

For the quantitative measurement of human chorionic gonadotropin (hCG) and its ß-subunit in human serum and plasma (heparin and EDTA) using the VITROS 5600 Integrated System to aid in the early detection of pregnancy.

The VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (test) is performed using the VITROS Immunodiagnostic Products Total β-hCG II Reagent Pack and VITROS Immunodiagnostic Products Total B-hCG II Calibrators on the VITROS 5600 Integrated System.

An immunometric immunoassay technique is used, which involves the reaction of human chorionic gonadotropin (hCG) present in the sample with a microwell coated with biotinylated Antibody (mouse monoclonal anti-ß-hCG) bound to streptavidin, and a Horseradish Peroxidase (HRP)-labelled antibody conjugate (mouse monoclonal anti-ß-hCG). Unbound materials are removed by washing.

The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of HRP conjugate bound is directly proportional to the concentration of hCG present in the sample.

VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack contains:
1 reagent pack containing:

• 100 coated wells (antibody, mouse monoclonal anti-ß-hCG, binds >600 mIU hCG/well)
• 14.4 mL assay reagent (buffer containing mouse serum, bovine serum albumin, bovine gamma globulin and . antimicrobial agent)
• 19.2 mL conjugate reagent (HRP-mouse monoclonal anti-β-hCG, binds ≥4005 mIU hCG/mL) in buffer with ● bovine serum albumin and antimicrobial agent.

VITROS Total ß-hCG II Calibrators contains:

• 3 sets of VITROS Total ß-hCG II Calibrators 1, 2 and 3, (freeze-dried, recombinant hCG in human plasma with antimicrobial agent, reconstitution volume 1.0 mL), nominal values 0; 3,000; 14,000 mIUmL (U/L)
• 24 calibrator bar code labels (8 for each calibrator)

Here's an analysis of the acceptance criteria and study information based on the provided text, structured according to your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a dedicated "acceptance criteria" table for all non-clinical tests. Instead, it describes each test (e.g., Precision, Detection Capability, Linearity) and then presents the results, implying that the results met internal acceptance criteria for substantial equivalence to the predicate device. Therefore, I will derive the "acceptance criteria" from the stated goals or industry guidelines mentioned for each test and then present the reported performance.

• 5.33 mIU/mL: 0.095 (1.80%)
• 15.46 mIU/mL: 0.181 (1.20%)
• 45.67 mIU/mL: 0.666 (1.50%)
• 297.34 mIU/mL: 4.970 (1.70%)
• 4708.50 mIU/mL: 82.29 (1.70%)
• 9651.00 mIU/mL: 286.71 (3.00%) |
  | Precision (Within Lab) | Evaluation consistent with CLSI document EP05-A3. (Specific %CV or SD targets not explicitly stated in this section, but implied by acceptable performance.) | Within Lab (SD/%CV):
• 5.33 mIU/mL: 0.281 (5.30%)
• 15.46 mIU/mL: 0.706 (4.60%)
• 45.67 mIU/mL: 1.560 (3.40%)
• 297.34 mIU/mL: 8.640 (2.90%)
• 4708.50 mIU/mL: 151.22 (3.20%)
• 9651.00 mIU/mL: 464.48 (4.80%)
  Further breakdown including Between Lot shows Total %CV up to 6.4% |
  | Detection Capability (LoB) | Evaluation consistent with CLSI document EP17-A2. Supporting the claimed LoB of 0.05 mIU/mL. | Representative LoB is 0.00 mIU/mL (IU/L), which supports the claimed LOB of 0.05 mIU/mL. |
  | Detection Capability (LoD) | Evaluation consistent with CLSI document EP17-A2. Supporting the claimed LoD of 0.70 mIU/mL. | Representative Limit of Detection (LoD) is 0.21 mIU/mL (IU/L), which supports the claimed LoD of 0.70 mIU/mL (IU/L). |
  | Detection Capability (LoQ) | Designed to be less than or equal to the claimed low end of the measuring range (2.39 mIU/mL) at 20% CV. Consistent with CLSI document EP17 (Total Error approach). | Representative LoQ using the Total Error approach was 2.32 mIU/mL (IU/L). Claimed LoQ verified at 2.39 mIU/mL (IU/L). |
  | Linearity | Established in accordance with CLSI guideline EP06 2nd edition. Results support linearity across the specified range. | Supported linearity from 1.51 mIU/mL (IU/L) to 15695 mIU/mL (IU/L). For Lot 2643, Slope was 0.991 (38.6 to 15695) and 1.025 (1.51 to 51.18); R2 was 0.996 and 0.999 respectively; % Recovery ranged from 92.2% to 112.7%. |
  | Measuring Range | The device is expected to have a measuring range on the VITROS 5600 system. | 2.39*-15,000 mIU/mL (IU/L). |
  | Matrix Comparison | Serum and plasma (Lithium-Heparin and K2-EDTA) specimen matrices determined to be equivalent. Results met acceptance criteria for comparison between serum and plasma spanning the expected measuring interval. | Weighted Deming Regression: Li-Hep Plasma (Slope 0.978, Corr. Coef r 0.999), K2-EDTA Plasma (Slope 0.978, Corr. Coef r 0.999). Serum and plasma (Li-Heparin and K2-EDTA) found suitable matrices. |
  | Analytical Specificity (Known Interferents) | Evaluated following CLSI EP07 and EP37. None found to cause a bias of >10% at specified hCG concentrations. | Over 30 common substances (e.g., Acetaminophen, Bilirubin, Biotin, Hemoglobin, Triglycerides) tested at high concentrations (e.g., Acetaminophen 15.6 mg/dL, Hemoglobin 1000 mg/dL, Triglycerides 1500 mg/dL) showed no bias >10% at hCG concentrations of 5.00, 50.00, and 10,000 mIU/mL. |
  | Analytical Specificity (Cross-Reactivity) | Evaluation for cross-reactivity with FSH, LH, and TSH in hCG negative samples and samples with ~25 mIU/mL hCG. | In hCG negative samples, FSH, LH, and TSH (at 400 mIU/mL and 200 mIU/mL respectively) were Not Detectable (ND). With a pool at ~25 mIU/mL hCG, % Cross Reactivity was: FSH (0.6%), LH (-0.3%), TSH (0.4%). |
  | Expected Values (Adult Reference Interval) | Validated following CLSI document EP28-A3c. Distribution of hCG values from normal healthy non-pregnant blood donors shows equivalency to the predicate device's expected values claim. | Original Claim: Total 290 samples, Mean 0.56, Min 0.00, Max 6.66, 2.5th Percentile 0.00, 97.5th Percentile 4.83.
  Updated Pack: Total 180 samples, Mean 0.47, Min 0.00, Max 5.61, 2.5th Percentile 0.00, 97.5th Percentile 3.73. Demonstrated equivalency. |
  | Method Comparison (Accuracy) | Evaluated consistent with CLSI guideline EP09c. Comparison with predicate device (VITROS Immunodiagnostic Products Total β-hCG II reagent pack, K063720). | n=135 samples. Slope 0.99 (95% CI: 0.977 to 0.995). Correlation Coefficient 0.998. Intercept -0.0215 (95% CI: -0.160 to 0.117). (Comparing VITROS Total ß-hCG II (GEM.1076A) against predicate VITROS Total B-hCG (GEM.1076)). Consistent with graphs indicating strong agreement. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Stability Studies:
  • Long-term: 3 Lots evaluated.
  • On-board: 3 Lots evaluated.
• Precision:
  • Single Lot Precision: 6 precision fluids. 2 replicates per run, 2 runs per day for 20 days. Total of 80 data points per fluid.
  • Additional Precision Analysis Summary: 6 samples (PP1-6).
  • Multiple System (Reproducibility) Study: 6 precision fluids (RP1-6). 5 replicates per run, 1 run per day for 5 days. Tested on 3 VITROS 5600 integrated systems.
• Detection Capability (LoB): 4 serums containing no measurable hCG. Study design: 2 replicates per run, 2 runs per day over 5 test days (20 reps per test fluid x 4 fluids = 80 replicates) x 3 lots = 240 total replicates.
• Detection Capability (LoD & LoQ): 5 LoD samples targeted at 1 to 5 times LoB. 4 LoQ fluids for Total Error method. All samples run using 3 reagent lots on one VITROS 5600 System. 6 replicates per run, 2 runs per day over 5 test days (60 reps per fluid x 5 fluids = 300 replicates) x 3 lots = 900 total replicates.
• Linearity: Two series: one across entire range (pools 1a to 10a) and one in lower range (pools 1b to 10b). 10 replicates of pools 1a/10 and 10a/10b, and 5 replicates of pools 2a/2b to 9a/9b. Run on one VITROS 5600 Integrated System.
• Matrix Comparison: 41 samples each for Lithium-Heparin Plasma and K2-EDTA Plasma.
• Analytical Specificity (Known Interferents): Not specifically quantified, but refers to "compounds tested" at three hCG concentrations.
• Analytical Specificity (Cross-Reactivity): hCG negative samples and hCG pools at approximately 25 mIU/mL were used for spiking test substances (FSH, LH, TSH).
• Expected Values (Adult Reference Interval):
  • Original Claim (from predicate): 290 total samples (98 normal male, 123 normal female, 69 post-menopausal).
  • Updated Pack Validation: 180 normal healthy non-pregnant blood donors (60 Normal Male, 60 Normal Female, 60 Post-Menopausal).
• Method Comparison: 135 human serum samples.

Data Provenance:

• The document states that human serum samples for method comparison were "obtained from certified vendors."
• Precision fluids mentioned as "pooling female serum samples."
• "Normal healthy non-pregnant blood donors" for expected values.
• "Neat serum samples containing low levels of endogenous hCG" for LoD samples.
• The overall context is non-clinical laboratory testing. No specific country of origin or retrospective/prospective status is explicitly stated for the patient samples used, though the tests themselves were conducted in a laboratory setting per CLSI guidelines. The stability studies and many precision studies seem to be prospective evaluations of the manufactured product. Patient samples, however, are often retrospectively collected from vendors in such studies unless specified.

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) test for quantitative measurement of hCG. The "ground truth" for such devices is established through reference methods, traceability to international standards, and comparison with legally marketed predicate devices, rather than expert human interpretation of images or clinical outcomes.

• Traceability: The device's calibration is traceable to "in-house reference calibrators, which have been value-assigned with reference to the 4th International Standard (NIBSC 75/589)." This international standard serves as the "ground truth" for the quantitative measurement.
• Method Comparison: The predicate device (VITROS Immunodiagnostic Products Total β-hCG II, K063720) serves as the comparative "ground truth" for assessing equivalence of performance with patient samples.

Therefore, there were no human "experts" (like radiologists) establishing ground truth in the way described for image-based diagnostic AI. The "ground truth" is defined by established metrological standards and comparative testing against a cleared predicate.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is an IVD device for quantitative measurement based on chemical reactions and instrumental readings. There is no human interpretation or subjective assessment of results that would require an adjudication method among experts.

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 IVD device, not an AI-assisted diagnostic tool that aids human readers in image interpretation or clinical decision-making. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device itself is a "standalone" analytical system in the context of laboratory testing. The VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack, used on the VITROS 5600 Integrated System, performs the quantitative measurement of hCG without immediate human intervention in the assay process itself. The "performance" sections (Precision, Detection Capability, Linearity, etc.) describe its standalone analytical performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for this IVD device is primarily:

• International Reference Standards: Specifically, the 4th International Standard (NIBSC 75/589) for hCG, to which the device's calibration is traceable.
• Comparison to a Legally Marketed Predicate Device: The performance of the new device is compared to the predicate device (VITROS Immunodiagnostic Products Total β-hCG II Reagent Pack, K063720), which established its own accuracy and reliability.
• CLSI Guidelines: Various CLSI (Clinical and Laboratory Standards Institute) documents (e.g., EP05-A3 for Precision, EP17-A2 for Detection Capability, EP06 for Linearity, EP07/EP37 for Interferents, EP28-A3c for Reference Intervals, EP09c for Method Comparison) define the acceptable methodologies for establishing truth and performance in laboratory diagnostics.

8. The sample size for the training set

This document describes a non-AI IVD device. There is no "training set" in the machine learning sense. The device is a chemical reagent pack used on an analyzer. Its "training" equivalent relies on the design, manufacturing tolerances, and calibration traceable to international standards.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for the device's fundamental function (accurate hCG measurement) is established through its traceability to international reference materials and validation against the predicate device, as detailed in point 7.

Ask a specific question about this device

iFlash-HCG is a paramagnetic particle chemiluminescent immunoassay (CLIA) for quantitative detection of the intact human chorionic gonadotropin (hCG) molecule and the hCG ß-subunit (ß-hCG) in human serum and plasma using the automated Chemiluminescence Immunoassay Analyzer (Model: iFlash-HCG assay is to be used by laboratory professionals as an aid in early detection of pregnancy together with other clinical methods.

Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is a fully-automated, chemiluminescence immunoassay analyzer intended for quantitative or qualitative determination of analytes in human body fluids taken from clinical settings. It is used together with its supporting chemiluminescence immunoassay reagence Immunoassay Analyzer (Model: iFlash 3000-C) is intended for use in clinical laboratories.

iFlash-HCG that includes testing reagents and three levels of calibrators is based on chemiluminescence immunoassay. HCG and hCG ß-subunit (ß-hCG) in the sample reacts with anti-HCG antibody coated paramagnetic microparticles and acridinium-labeled anti-HCG antibody conjugate to form a sandwich complex, after chemiluminescent reaction, HCG amount in the sample is derived from RLUs (relative light units) using a calibration curve. iFlash-HCG is intended to be used on Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C).

Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is a fully-automated, chemiluminescence immunoassay analyzer intended for quantitative determination of analytes in human body fluids taken from clinical settings. It is used together with its supporting chemiluminescence immunoassay reagents. The Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is intended for use in clinical laboratories.

The provided text describes the performance of the iFlash-HCG and Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) for the quantitative detection of human chorionic gonadotropin (hCG). However, it does not detail acceptance criteria in a structured table or specifically describe a "study that proves the device meets the acceptance criteria" in terms of clinical performance against defined benchmarks with human experts, as would be typical for an AI/ML-based diagnostic device where acceptance criteria often relate to sensitivity, specificity, and agreement with ground truth.

Instead, the document focuses on detailed non-clinical performance studies demonstrating the analytical characteristics and substantial equivalence to a predicate device. Many of the listed studies (e.g., precision, detection capability, linearity, interference, analytical specificity, method comparison, stability, trueness, sample dilution, reference interval, carryover) are standard for in vitro diagnostic (IVD) devices.

Given the input, I will interpret "acceptance criteria" as the performance specifications demonstrated by the non-clinical studies and "study that proves the device meets the acceptance criteria" as the results of these non-clinical studies. I will also clarify that this is not an AI/ML device per se, so the typical AI/ML study components (experts for ground truth, MRMC, standalone algorithm performance) are not applicable in their traditional sense.

Here's the information extracted and structured based on your request, with caveats where the information is not present or not applicable to an IVD device of this type:

1. Table of Acceptance Criteria and Reported Device Performance

As the document does not provide a pre-defined table of "acceptance criteria" in the sense of pass/fail thresholds for clinical performance but rather lists the results of various analytical performance studies, I will present the key performance parameters and their achieved values. The "acceptance criteria" here are implicitly met if the reported performance is deemed suitable for the intended use and demonstrates substantial equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (for performance studies):

  • Precision: 9 levels of female serum samples and 2 levels of controls (total samples tested over 20 days: 9 samples * 2 runs * 2 replicates * 20 days * 3 lots * 3 analyzers = substantial, specific number of unique patients/samples not given).
  • Detection Limit (LoB): 5 analyte-free samples * 4 times/day * 3 days * 3 reagent lots (60 results per reagent lot).
  • Detection Limit (LoD): 5 low-concentration samples * 4 times/day * 3 days * 3 reagent lots (60 test results per reagent lot).
  • Detection Limit (LoQ): 5 samples near LoD * 4 times/day * 3 days * 3 reagent lots (60 test results per reagent lot).
  • Linearity: 11 different concentration levels of samples for each of 3 linearity intervals tested on 3 reagent lots.
  • Hook Effect: 3 high concentration samples and their serial dilutions.
  • Interference Study: Not specified, but likely involved multiple samples spiked with interferents.
  • Analytical Specificity: Not specified, but likely involved multiple samples spiked with cross-reactants.
  • Specimen Types Study: 97 female serum samples compared with plasma samples.
  • Method Comparison: 110 serum samples.
  • Trueness Study: Samples formulated from WHO International Standard (3 concentration levels).
  • Sample Dilution Fold Study: Samples prepared with HCG positive material (3 theoretical concentrations).
  • Reference Interval Study: Non-pregnant premenopausal women (N=130), Postmenopausal women (N=125).
  • Carryover Study: Test samples with high HCG in triplicate followed by low HCG in triplicate, for five runs.

• Data Provenance: The document does not explicitly state the country of origin for the clinical samples used in these studies. It does indicate that the submitter is based in Shenzhen, Guangdong, China. The studies are described as non-clinical performance studies, often implying controlled laboratory conditions rather than broad population-based data collection. All studies appear to be prospective as they are specifically conducted to evaluate device performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This is an IVD device for quantitative measurement of hCG, not an AI/ML medical image analysis or similar diagnostic device that typically relies on human expert interpretation for "ground truth." The ground truth for this device's performance is established by reference methods, certified reference materials (like WHO International Standard 5th WHO IS Chorionic Gonadotrophin 07/364), and comparison with legally marketed predicate devices. Therefore, the concept of "experts" establishing conventional ground truth as applied to AI/ML clinical studies is not applicable here.

4. Adjudication Method for the Test Set

As there are no human experts classifying or interpreting data for "ground truth" in the AI/ML sense, there is no adjudication method described or applicable. The determination of results is based on the chemical reaction and optical detection by the automated analyzer, with analytical results compared to established reference values or predicate device results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study is relevant for diagnostic devices (often imaging-based or AI-assisted) where human reader performance is a key outcome. This document describes an automated IVD assay, not an imaging device or an AI assistance tool for human readers. Therefore, no MRMC comparative effectiveness study was done, and the concept of human readers improving with AI assistance is not applicable.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This device is a standalone automated analyzer ("algorithm only" in the sense of the instrument performing the test independently). The entire suite of non-clinical performance studies (precision, detection limits, linearity, interference, method comparison, etc.) constitutes the demonstration of its standalone analytical performance. It does not require human-in-the-loop for its operation or result generation in the same way an AI diagnostic algorithm might.

7. The Type of Ground Truth Used

The "ground truth" for the analytical validation of this IVD device is primarily based on:

• Reference materials/standards: Notably, the WHO International Standard 5th WHO IS Chorionic Gonadotrophin 07/364 is used for trueness studies.
• Spiked samples: Known concentrations of analytes or interferents are added to samples to confirm recovery and specificity.
• Comparison to predicate devices: The results from the iFlash-HCG are compared against those from the cleared predicate devices (Elecsys HCG+β reagent and Cobas e 801 analyzer) to demonstrate substantial equivalence.
• Consensus methods/protocols: CLSI guidelines (EP05-A3, EP17-A2, EP06 2nd Edition, EP07-A3, EP37 1st Edition, EP09c 3rd Edition, EP25-A, EP34 1st Edition, EP28-A3c, H26-A2) provide the "ground truth" for how studies should be designed and how performance metrics should be calculated and interpreted.

8. The Sample Size for the Training Set

This document describes a conventional IVD assay and analyzer, not an AI/ML system that undergoes a distinct "training" phase with a large dataset. Therefore, the concept of a "training set" for an AI/ML algorithm is not applicable in this context. The methodology relies on established chemical and physical principles, not machine learning from data.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the AI/ML sense, this question is not applicable. The device's performance is inherently determined by its design specifications, reagents, and analytical principles, validated through the non-clinical studies.

Ask a specific question about this device

GLP systems Track:

The GLP systems Track is a modular laboratory automation system designed to automate pre-analytical and post-analytical processing, including sample handling, in order to automate sample processing in clinical laboratories. The system consolidates multiple analytical instruments into a unified workflow.

Alinity i Total β-hCG Reagent Kit:

The Alinity i Total β-hCG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative and qualitative determination of beta-human chorionic gonadotropin (ß-hCG) in human serum and plasma for the early detection of pregnancy on the Alinity i analyzer.

Alinity i system:

The Alinity i System is a fully automated analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology is used to determine the presence of antibodies, and analytes in samples.

Alinity ci-series:

The Alinity ci-series is intended for in vitro diagnostic use only.

The Alinity ci-series is a System comprised of inity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations including up to four Alinity i processing modules, up to four Almity c processing modules, or a combination of up to four of Alinity c processing modules with a shared system control module to form a single workstation.

The Alinity c System is a fully automated, random/continuous access, climical chemistry analyzer intended for the in vitro determination of analytes in body fluids.

The Alinity i System is a fully automated analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology is used to determine the presence of antibodies, and analytes in samples.

The GLP systems Track is a modular laboratory automation system (LAS) used to perform multiple pre-analytical and post-analytical steps to automate sample preparation and distribution processes in clinical laboratories. These processes include bar code identification of samples, centrifugation, aliquoting of samples, decapping of samples, transport of samples between processes (modules), delivery of samples to 1 or more Abbott and Third Party commercially available laboratory analyzer(s), capping of samples, and storage of samples. Due to the modular nature of the LAS, customers may select modules and configurations to fit their laboratory needs.

The provided text describes the 510(k) premarket notification for the GLP systems Track and the Alinity i Total β-hCG Reagent Kit. The focus of the acceptance criteria and study detailed in the document is on the GLP systems Track laboratory automation system, and its ability to maintain the performance of connected analyzers, specifically exemplified with the Alinity i Total β-hCG assay. The document does not provide specific acceptance criteria or performance data for the Alinity i Total β-hCG Reagent Kit as a standalone diagnostic assay; instead, it focuses on the GLP systems Track's compatibility and non-inferiority when integrated with such assays.

Here's a breakdown of the information based on your request:

Acceptance Criteria and Reported Device Performance

The document describes a method comparison study to demonstrate that the GLP systems Track does not negatively impact the performance of connected assays. The acceptance criteria are implicitly defined by the results of this method comparison.

Table of Acceptance Criteria and Reported Device Performance (Implicit for the GLP systems Track):

* **Slope:** 0.99
* **Correlation Coefficient:** 1.00                                                                                                                                                                       |

| Ensure acceptable performance for a representative immunoassay. | Demonstrated with the Alinity i Total β-hCG assay. |

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated as a number of samples. The range of mIU/mL for the tested samples is given as 4.78 to 14,965.80 mIU/mL, indicating a broad range of concentrations were tested.
   • Data Provenance: The study was described as "Nonclinical testing was performed on-site at Abbott." This indicates an internal, prospective study. Country of origin is implicitly the US, where Abbott Laboratories is located.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Not applicable. This was a method comparison study for a laboratory automation system, not a diagnostic study requiring human expert interpretation of results to establish ground truth. The "ground truth" was established by comparing direct loading (comparator method) to processing via the GLP systems Track (investigational method) using established laboratory procedures.

3. Adjudication Method for the Test Set:

   • Not applicable. As this was a method comparison of automated systems, there was no human adjudication process involved. The comparison was based on quantitative measurements.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. An MRMC study is typically for image-based diagnostic aids where human readers interpret cases. This study focused on the performance of a laboratory automation system.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, in essence. The study assessed the performance of the GLP systems Track (an automated system) without human intervention in the analytical process, demonstrating its ability to deliver results comparable to direct sample loading. The Alinity i Total β-hCG assay itself is a standalone quantitative assay.

6. The Type of Ground Truth Used:

   • Reference Method Comparison/Comparator Method. The "ground truth" was established by testing specimens on the Alinity i Total β-hCG assay when front-loaded (the comparator method/reference) and comparing those results to specimens loaded using the GLP systems Track (investigational method). This essentially assumes that the front-loaded method provides the accurate measurement.

7. The Sample Size for the Training Set:

   • Not applicable. The GLP systems Track is a mechanical/software automation system designed for sample processing, not an algorithm that undergoes "training" with data in the typical machine learning sense to learn patterns or make predictions. Its "training" would be through engineering design, development, and testing processes. The document does not mention any machine learning or AI components that would require a training set.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable. (See point 7).

In summary, the provided document focuses on demonstrating the substantial equivalence of the GLP systems Track to its predicate and its ability to integrate with and maintain the performance of an existing cleared assay (Alinity i Total β-hCG) through a nonclinical method comparison study.

Ask a specific question about this device

The Alinity ci-series is intended for in vitro diagnostic use only.

The Alinity ci-series is a System comprised of inity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations including up to four Alinity i processing modules, up to four Alinity c processing modules, or a combination of up to four of Alinity i and Alinity c processing modules with a shared system control module to form a single workstation.

The Alinity c System is a fully automated, random/continuous access, clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids.

The Alinity i System is a fully automated analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology is used to determine the presence of antigens, antibodies, and analytes in samples.

The Alinity c ICT (Integrated Chip Technology) is used for the quantitation of sodium, and chloride in human serum, plasma, or urine on the Alinity c analyzer.

Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension. Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The Alinity c Glucose Reagent Kit is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the Alinity c analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Alinity i Total B-hCG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative and qualitative determination of beta-human chorionic gonadotropin (B-hCG) in human serum and plasma for the early detection of pregnancy on the Alinity i analyzer.

The Alinity ci-series is comprised of individual Alinity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations which include either multiple Alinity i processing modules, multiple Alinity c processing modules, or a combination of up to four of both Alinity i and Alinity c processing modules with a shared system control module (SCM). The SCM includes the reagent and sample manager (RSM). The multimodule configurations do not have a separate device label or list number. In a multimodule configuration, each processing module retains its original unique identification label.

The document describes the non-clinical performance evaluation of the Alinity ci-series system, Alinity i Total ß-hCG Reagent Kit, Alinity c Glucose Reagent Kit, and Alinity c ICT Sample Diluent. The study focuses on demonstrating equivalent performance between the original single-module configurations and the new multi-module configurations.

Here's an breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating "equivalent performance" between the investigational multimodule system and the previously cleared single-module predicate devices. The reported performance metrics are precision (%CV) and method comparison parameters (slope and correlation coefficient). The document doesn't explicitly state numerical acceptance criteria thresholds, but rather implies that the observed results were within an acceptable range for "equivalent performance."

2. Sample size used for the test set and the data provenance

The document does not explicitly state the exact sample sizes (number of patient samples) for the precision and method comparison studies. It provides ranges of analyte concentrations, implying that multiple samples spanning these ranges were tested.

• Precision Studies: Samples across various concentration ranges (e.g., 5.25 to 12,850 mIU/mL for ß-hCG, 7 to 688 mg/dL for glucose serum, etc.) were used. The term "5-day precision" suggests a study design where samples are run over 5 days to assess within-laboratory variability.
• Method Comparison Studies: Samples across various concentration ranges were used (e.g., 2.74 to 14,998.60 mIU/mL for ß-hCG, 14 to 659 mg/dL for glucose serum, etc.).

Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that it's a pre-market submission to the FDA, the studies are typically prospective and conducted by the manufacturer, often at their own facilities or clinical study sites.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this type of device. The ground truth for quantitative laboratory assays is typically established by reference methods or the performance of a cleared predicate device, not by expert consensus or physician review in the way it would be for imaging diagnostics. The "ground truth" here is the measurement obtained from the previously cleared single-module systems.

4. Adjudication method for the test set

Not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation (e.g., radiology reads) to resolve discrepancies among multiple expert reviewers. Here, the comparison is against quantitative measurements from a reference or predicate system.

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 submission is for an in vitro diagnostic (IVD) system that performs automated quantitative measurements, 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 refers to the performance of the automated Alinity ci-series system. The studies described (precision and method comparison) are essentially standalone performance evaluations comparing the new multimodule system to the existing single-module systems. There is no "human-in-the-loop" component in the sense of an operator making diagnostic interpretations based on the output. Operators load samples and reagents and manage the system, but the analytical measurement itself is automated.

7. The type of ground truth used

The ground truth used for comparison in these non-clinical studies is the performance of the predicate devices (Alinity i System for Alinity i Total ß-hCG, and Alinity c System for Alinity c Glucose and ICT assays) in their single-module configurations. The goal was to demonstrate "equivalent performance" of the new multimodule configurations to these already cleared systems. This is a form of comparative effectiveness against a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This document describes the validation of a laboratory instrument system and reagent kits through non-clinical performance studies (precision, method comparison), not an AI/machine learning model that requires a distinct "training set." The methodology involves biochemical reactions and optical/potentiometric detection, which are established principles, not learned from a dataset.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of an AI/ML model for this device.

Ask a specific question about this device

The Access Total BhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total βhCG levels in human serum and plasma using the Access Immunoassay Systems. This assay is intended for use as an aid in the early detection of pregnancy.

The Access Total βhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total βhCG levels in human serum and plasma using the Access Immunoassay Systems. This assay is intended for use as an aid in the early detection of pregnancy.

Here's a breakdown of the acceptance criteria and study information for the Access Total βhCG (5th IS) device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state the specific sample sizes used for each test (e.g., Method Comparison, Imprecision, Linearity, Reproducibility, LoB/LoD/LoQ). It discusses general results of "studies" but doesn't provide granular details on the number of samples or specimens.

The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is an in vitro diagnostic (IVD) immunoassay for the quantitative determination of total βhCG levels. The ground truth for such devices is typically established through analytical methods and reference standards, not through expert human interpretation of images or clinical cases.

4. Adjudication Method for Test Set

Not applicable. As this is an IVD immunoassay, an "adjudication method" involving human experts (like 2+1 or 3+1 for clinical case interpretation) is not relevant. The performance is assessed against analytical criteria and reference standards.

5. MRMC Comparative Effectiveness Study

Not applicable. This is an in vitro diagnostic (IVD) device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

6. Standalone (Algorithm Only) Performance

Yes, the studies described (Method Comparison, Imprecision, Linearity, Reproducibility, LoB/LoD/LoQ) demonstrate the standalone performance of the Access Total βhCG (5th IS) assay on the DxI 9000 Access Immunoassay Analyzer. These are analytical performance characteristics of the device itself, without human-in-the-loop interpretation.

7. Type of Ground Truth Used

The ground truth for the analytical performance studies (such as LoQ determination) was established by comparison to the WHO 5th International Standard for Chorionic Gonadotropin (NIBSC Code 07/364). This is a recognized international reference standard.

8. Sample Size for Training Set

Not applicable. This is an immunoassay, which does not typically involve a "training set" in the context of machine learning algorithms. Its design and calibration are based on chemical principles and validation against reference materials.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the machine learning sense for this device. The ground truth for ensuring the device's accuracy and performance is established through rigorous analytical verification using reference standards like the WHO International Standard.

Ask a specific question about this device

Diazyme DZ-Lite iFlash Total BhCG Assay is a chemiluminescent immunoassay intended for use for the quantitative determination of total beta-human chorionic gonadotro pin (total BhCG) in human serum on DZ-Lite iFlash 1800 Chemiluminiscence Immunoassay Analyzer. The assay is intended for use as an aid in the early detection of pregnancy. Diazyme DZ-Lite iFlash 1800 Chemiluminiscence Immunoassay Analyzer is used clinically in combination with the supporting chemiluminescence immunoassay reagents for determination of analytes in human body fluids through acridinium ester-based chemiluminescence method.

Diazyme DZ-Lite iFlash Total BhCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer

This particular document (K212221) is an FDA 510(k) clearance letter, which formally states that the Diazyme DZ-Lite iFlash Total BhCG Assay and Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer are "substantially equivalent" to legally marketed predicate devices.

This document itself does NOT contain the detailed study information (acceptance criteria, test results, sample sizes, ground truth establishment, etc.) that you are asking for.

Typically, this detailed information would be found in the 510(k) summary document submitted by the manufacturer to the FDA, or in the underlying scientific reports and validation studies that formed the basis for the 510(k) submission. The clearance letter only refers to the submission and acknowledges its review.

Therefore, I cannot provide the specific answers to your detailed questions based solely on the provided text. To answer your questions, I would need access to the full 510(k) submission documents, particularly the "510(k) Summary" and potentially the "Device Description" and "Performance Data" sections.

If you had the 510(k) summary, here's how I would typically extract and present the information you requested (using placeholder text where the information is missing from the current document):

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size: [e.g., X number of clinical serum samples; Y number of spiked samples]
• Data Provenance: [e.g., Retrospective clinical samples collected from hospitals in the United States and Europe; Spiked samples prepared in-house; Prospective clinical samples from a multi-center study in [Country/Region]]

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: N/A (For an immunoassay like BhCG, "ground truth" is typically established by reference methods or validated laboratory methods, not expert consensus in the diagnostic imaging sense).
• Qualifications of Experts: N/A

4. Adjudication method for the test set

• Adjudication Method: N/A (Ground truth for immunoassay is typically based on a gold standard measurement method, not human adjudication of interpretations).

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

• MRMC Study: No. This device is an in vitro diagnostic (IVD) immunoassay, not an imaging AI device that assists human readers. Therefore, an MRMC study is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Yes. The performance data presented (e.g., accuracy, precision, LoD, linearity) is the standalone performance of the Diazyme DZ-Lite iFlash Total BhCG Assay on the Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer. The device is designed to provide a quantitative result directly.

7. The type of ground truth used

• Type of Ground Truth: For the Diazyme DZ-Lite iFlash Total BhCG Assay, the "ground truth" is established through:
  • Reference Methods: Comparison of results with a legally marketed predicate device or a clinical laboratory gold standard method (e.g., another highly accurate BhCG assay, often traceably calibrated to the 1st IRP WHO standard).
  • External Quality Control Materials: Samples with known concentrations.
  • Spiked Samples: Negative samples to which known concentrations of BhCG are added.
  • Patient Samples: Clinical samples from various populations (pregnant, non-pregnant, specific medical conditions) with BhCG levels confirmed by reference methods.

8. The sample size for the training set

• Training Set Sample Size: This is generally not applicable in the same way it is for AI/machine learning algorithms. For IVD devices, the development involves optimizing reagents and assay parameters through extensive R&D, rather than "training" an algorithm on a distinct dataset. The "training" would be part of the assay development and optimization process, not a separate, quantified "training set."

9. How the ground truth for the training set was established

• Ground Truth for Training Set: N/A (See #8 above). The assay development aims to accurately measure BhCG, and the establishment of its accuracy and other performance characteristics relies on the scientific principles of immunoassay and validation against reference materials and methods.

Ask a specific question about this device

For the in vitro quantitative determination of human chorionic gonadotropin (hCG) in human serum and plasma. The Elecsys HCG STAT immunoassay is intended for use in the early detection of pregnancy. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 601 immunoassay analyzer.

The Elecsys HCG STAT immunoassay makes use of a sandwich test principle using monoclonal antibodies specifically directed against Human Chorionic Gonadotropin (HCG). The antibodies labeled with ruthenium complex consist of a chimeric construct from human and mouse specific components. The Elecsys HCG STAT immunoassay is used for the in vitro quantitative determination of human chorionic gonadotropin (hCG) in human serum and plasma. It is intended for use on the cobas e 601immunoassay analyzer.

The provided text describes the Elecsys HCG STAT immunoassay, its intended use, technological characteristics, and non-clinical performance evaluations conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study information as requested:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance, but rather lists the performance data obtained and states that "All performance specifications were met." We can infer the acceptance criteria from the context of typical FDA 510(k) submissions for in vitro diagnostics, where equivalence to the predicate and meeting standard analytical performance metrics are key.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Precision (21-Day): Five human serum samples (HS1-HS5) and two controls (PreciControl Universal level 1 and 2). Replicated twice per run, two runs per day for 21 days (total 84 replicates per sample/control per lot). 1 lot used.

• Precision (5-Day): Five human serum samples (HS1-HS5) and two controls (PreciControl Universal level 1 and 2). 5 aliquots per run, 1 run per day for 5 days. 3 lots used.

• Reproducibility: Six human serum samples (HSP 1-6) and two controls (CTR 1-2). 5 replicates per run, 1 run per day. 1 lot used.

• LoB (Limit of Blank): Five analyte-free samples, measured in two-fold determinations in 6 runs over ≥ 3 days. 2 different lots. Total 60 measured values per lot.

• LoD (Limit of Detection): Five low-analyte concentration samples (from LoB up to approx. 4x LoB), measured in two-fold determinations in 6 runs over ≥ 3 days. 2 different lots. Total 60 measured values per lot.

• LoQ (Limit of Quantitation): 5 human serum samples covering the range between LoB and 2x LoQ. Measured in 5 replicates, one run per day over 5 days. 2 lots evaluated.

• Linearity/Assay Reportable Range: One human serum sample (high analyte), diluted through 21 steps. Assayed in 3-fold determinations. 1 lot tested.

• High Dose Hook Effect: Three human serum samples spiked with HCG. Dilution series performed. 1 reagent lot.

• Endogenous Interferences: One lot tested on 3 samples of each interfering substance (Hemoglobin, Intralipid, Bilirubin, Rheumatoid Factors). Each HCG sample (low, medium, high) spiked with interferent in 9 dilution steps.

• Biotin Interference: Three serum samples (low, medium, high HCG concentration) spiked with biotin up to 3600 ng/mL in 11 dilution steps.

• Common Drug Interferences: One human serum sample (HCG conc. near 5 mIU/mL and near 50 mIU/mL), spiked with 17 common pharmaceutical compounds.

• Analytical Specificity/Cross-Reactivity: One human serum matrix with HCG level (5 mIU/mL) spiked with LH, FSH, TSH. 1 reagent lot.

• Sample Matrix Comparison: At least 40 serum/plasma pairs were tested in one run.

• Method Comparison to Predicate: 131 samples covering the measuring range. Tested with 1 run per sample.

• Data Provenance (Country of Origin): The document does not explicitly state the country of origin for the data. Given Roche Diagnostics' global presence, the studies could have been conducted in various locations.

• Retrospective or Prospective: These studies appear to be prospective analytical performance studies, specifically designed and executed to evaluate the device characteristics described. The phrases "Precision was evaluated...", "LoB ... was determined...", "A method comparison ... was conducted..." all indicate planned experiments.

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 section is not applicable as the Elecsys HCG STAT is an in vitro diagnostic (IVD) immunoassay, not an AI or imaging device requiring human expert ground truth for interpretation of images or clinical cases. The "ground truth" for its performance is established through quantitative measurements against known standards, spiked samples, and comparison to a legally marketed predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical evaluations where there is subjective human interpretation (e.g., radiology reads) and disagreement among readers needs resolution.

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 section is not applicable. The Elecsys HCG STAT is an automated immunoassay for quantitative determination of hCG. It does not involve human readers interpreting output that would be improved or supplemented by AI. It is a standalone diagnostic test.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone performance evaluation was completed. The studies described (precision, detection limits, linearity, interference, method comparison) are all evaluations of the Elecsys HCG STAT immunoassay system (reagent + instrument) performance without human intervention in the measurement process. The results generated by the device are quantitative values of hCG concentration.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device's performance evaluation typically involves:

• Known concentrations: For studies like LoD, LoQ, Linearity, Interference, where samples are prepared with known, precise concentrations of hCG or interfering substances.
• Standardized materials: Traceability to the 4th International Standard for Chorionic Gonadotropin from NIBSC code 75/589.
• Quantitative measurements by a predicate device: For method comparison studies, the predicate device's results serve as a reference for comparison, establishing "ground truth" for demonstrating substantial equivalence.
• Reference measurement procedures: Although not explicitly stated, general analytical performance studies rely on highly accurate reference methods or certified reference materials where available.

8. The sample size for the training set

This section is not applicable. The Elecsys HCG STAT is an immunoassay, not an AI or machine learning algorithm that requires a "training set" in the computational sense. The device's parameters are likely established during development and manufacturing through calibration and optimization procedures, not through a 'training set' of cases as understood in AI studies.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

Ask a specific question about this device

For in vitro diagnostic use in the quantitative determination of human chorionic gonadotropin (hCG) in serum or plasma (EDTA or lithium heparin) using the ADVIA Centaur® XP system.

Human chorionic gonadotropin measurements are intended for use as an aid in the early detection of pregnancy.

The ADVIA Centaur® Total hCG assay reagents come in the following configurations:
5 ReadyPack primary reagent packs containing ADVIA Centaur Total hCG Lite Reagent and Solid Phase ADVIA Centaur and ADVIA Centaur CP Total hCG Master Curve card (250 Tests)
1 ReadyPack primary reagent pack containing ADVIA Centaur Total hCG Lite Reagent and Solid Phase ADVIA Centaur and ADVIA Centaur CP Total hCG Master Curve card (50 Tests)

The ReadyPack consists of the following:
ADVIA Centaur ThCG ReadyPack® primary reagent pack; Lite Reagent: 5.0 mL/reagent pack polyclonal goat anti-hCG antibody (~0.1 µg/mL) labeled with acridinium ester in buffered saline with sodium azide (0.1%) and preservatives
ADVIA Centaur ThCG ReadyPack primary reagent pack; Solid Phase Reagent: 22.5 mL/reagent pack monoclonal mouse anti-hCG antibody (~0.02 mg/mL) covalently coupled to paramagnetic particles in buffered saline with sodium azide (0.1%) and preservatives
ADVIA Centaur ThCG ReadyPack ancillary reagent pack; ThCG Diluent: 25.0 mL/reagent pack buffered heat-treated equine serum with EDTA, sodium azide (

This document describes the validation of the ADVIA Centaur® Total hCG assay, primarily focusing on the addition of plasma (EDTA and lithium heparin) sample claims.

Here's an analysis of the acceptance criteria and the studies that demonstrate the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

• Detection Capability: No specific sample size disclosed for LOB/LOD/LOQ determination in this summary.
• Precision: 320 total replicates for each of the 6 samples (3 serum, 3 control) over 20 days (e.g., 2 runs/day x 20 days x 2 replicates/run).
• Method Comparison: 117 samples (range 7.6 to 977.6 mIU/mL).
• Specimen Equivalence: 53 pairs for Dipotassium EDTA plasma vs. Serum; 51 pairs for Lithium heparin plasma vs. Serum.
• Linearity: Samples spanning the entire assay range. Specific number not provided.
• Dilution Recovery: Multiple samples tested across 4 dilution ratios (1:2, 1:4, 1:8, 1:16). Number of individual samples varies per dilution.
• Interferences (General, HIL): Not explicitly stated, but performed "used the paired-difference approach" at two analyte concentrations for each interferent.
• Expected Values (Reference Range): 130 non-pregnant females (≤40) and 150 postmenopausal females (≥41).
• Cross-Reactivity: Not explicitly stated, but multiple hCG values (low to high) tested against each cross-reactant.

Data Provenance: The document does not explicitly state the country of origin for the clinical samples. It is a submission by Siemens Healthcare Diagnostics, Inc. based in Tarrytown, New York, USA, suggesting the work was likely conducted or overseen in the USA, but the origin of patient samples is not specified. The studies are retrospective, as they involve characterizing the performance of the assay with collected samples, rather than following patients prospectively as part of the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For in vitro diagnostic assays like this, which measure an analyte (hCG), the "ground truth" is typically the concentration of the analyte itself, often established by a reference method or highly characterized reference materials for standardization, or by the clinical diagnosis. This is not a device where human experts (e.g., radiologists) interpret images or clinical data to establish a ground truth.

• Standardization: The ADVIA Centaur Total hCG assay is traceable to the World Health Organization (WHO) 5th IS 7/364 reference material. This material itself serves as the 'ground truth' for defining hCG concentration.
• Expected Values: The reference range study for Non-Pregnant and Postmenopausal Females established through a CLSI guideline, where the "ground truth" for non-pregnant status would be clinical assessment, and the hCG measurement would be the result to define the range.

Therefore, the concept of "number of experts used to establish ground truth" as it applies to image interpretation or clinical diagnosis is not directly applicable here. The ground truth is fundamentally analytical (traceability to reference standards) and clinical classification (e.g., non-pregnant status).

4. Adjudication Method for the Test Set

Not applicable for this type of in vitro diagnostic device study. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where individual expert opinions need to be reconciled for clinical endpoints or image interpretations. Here, the studies are analytical performance evaluations.

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 device is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging device or a system involving human readers interpreting outputs.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are for the standalone analytical performance of the ADVIA Centaur® Total hCG assay. The device measures hCG quantitatively; its performance characteristics (precision, linearity, interference, etc.) are inherent to the assay and instrument system, independent of human interpretation of the measurement itself. The "without human-in-the-loop" concept applies.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth depends on the specific performance characteristic:

• Analytical Ground Truth: For characteristics like method comparison, linearity, dilution recovery, interferences, and cross-reactivity, the ground truth is often defined by:
  • Reference Methods: The predicate device (Atellica IM ThCG assay)
  • Spiked Samples: Known concentrations of analyte or interfering substances added to samples.
  • Traceability to International Standards: WHO 5th IS 7/364 reference material.
• Clinical Ground Truth: For the "Expected Values" study, the ground truth of "non-pregnant" or "postmenopausal" status would be established through clinical assessment of the individuals providing the samples.

8. The Sample Size for the Training Set

This document describes a 510(k) submission for an in vitro diagnostic (IVD) assay, not a machine learning or AI algorithm development. Therefore, the concept of a "training set" in the context of AI is not applicable. The assay's methods are based on established immunoassay principles, and the performance characteristics are determined through analytical validation studies.

9. How the Ground Truth for the Training Set Was Established

As explained in point 8, the concept of a training set for an AI/ML algorithm is not relevant for this traditional IVD assay validation. The assay is developed based on scientific and chemical principles, and its performance is validated against specific criteria using various types of samples.

Ask a specific question about this device

MAGLUMI 2000 HCG/S-HCG is an in vitro chemiluminescence immunoassay for the quantitative determination of total beta human chorionic gonadotropin (total ß-hCG) in human serum. The measurement of total ß-hCG is used as an aid in the early detection of pregnancy.

MAGLUMI 2000 HCG/B-HCG kit consists of the following reagents: Magnetic Microbeads- coated with anti-HCG monoclonal antibody, containing BSA, NaN3 (

The provided text describes the performance characteristics of the MAGLUMI 2000 HCG/ß-HCG device, an in vitro chemiluminescence immunoassay for the quantitative determination of total beta human chorionic gonadotropin (total ß-hCG) in human serum. This information is presented as part of a 510(k) summary submitted to the FDA. While the document outlines various analytical performance studies, it does not explicitly define acceptance criteria in a quantitative table or refer to a multi-reader multi-case (MRMC) comparative effectiveness study.

However, we can infer acceptance based on the reported performance results aligning with standard clinical laboratory expectations and the successful substantial equivalence determination by the FDA. The study focuses on analytical performance characteristics rather than diagnostic accuracy involving human interpretation of results.

Here's an attempt to structure the information based on your request, identifying what is and isn't available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria. Instead, it describes performance characteristics and indicates compliance with CLSI guidelines. We can infer the "acceptance" derived from the presented data and the overall conclusion of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Precision Study: 80 samples analyzed per level (Control 1, Control 2, Control 3, Calibrator Low, Calibrator High, and 6 Native Serum Pools) on each of three instruments. Total N=240 samples per level across three instruments.
• Linearity Study: Linearity samples prepared by mixing high and low level samples. Each sample was measured in quadruple on 3 lots of reagent. The exact number of distinct linearity samples (different concentrations) is not specified, but the range is 0.3 to 4680 mIU/mL.
• Detection Limit Studies:
  • LOB: 80 measurements of HCG/ß-HCG negative serum samples using 3 different lots over 5 days.
  • LOD: Four levels of low samples, measured in 80 replicates over 5 days per sample using 3 lots of reagents.
  • LOQ: Six low serum samples, in six replicates per run, one run per day, over 5 days, using 3 lots of reagents.
• Interference Study: Two base serum samples (6.0 mIU/mL and 100 mIU/mL HCG/ß-HCG) spiked with various cross-reactants. Also, human serum pools with 6.0 mIU/mL, 100 mIU/mL, and 2000 mIU/mL HCG/ß-HCG for endogenous substances and common drugs. Each tested using 3 lots of reagents. Exact number of distinct interferent samples not specified.
• Hook Effect: Six samples with HCG/ß-HCG concentrations from 5000 to 1,000,000 mIU/mL prepared by spiking. Serial dilutions tested using 3 different lots.
• On-board Dilution Recovery: Twelve serum samples with HCG/ß-HCG concentrations from 4475 to 223750 mIU/mL tested using three reagent lots and three instruments.
• Method Comparison Study: 201 human serum samples with concentrations ranging from 1.1 to 4934 mIU/mL (as determined by the predicate device).
• Expected Values/Reference Range: 431 serum samples from non-pregnant, apparently healthy females (20 years and older).

Data Provenance: The document does not explicitly state the country of origin for the data. Given the submitter's location (Shenzhen, China) and the FDA submission, it's likely the studies were conducted in China or involved samples from that region, but this is not explicitly confirmed. The studies are described in a manner typical of prospective performance evaluation studies for an in vitro diagnostic device, rather than retrospective analysis of pre-existing data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The device is an in vitro diagnostic immunoassay for quantitative measurement of a biomarker (hCG). Ground truth is established by the reference measurement procedure of the MAGLUMI 2000 instrument itself and validated through analytical performance studies (precision, linearity, detection limits, method comparison to a legally marketed predicate device, etc.) rather than through expert human interpretation of images or clinical findings.

4. Adjudication Method for the Test Set

Not applicable. As the device is an in vitro diagnostic assay providing a quantitative numerical result, there is no human interpretation or subjective assessment that would require an adjudication method. The "ground truth" for method comparison is the value obtained from the predicate device. For analytical performance studies, it's the objectively measured values and their statistical distributions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is typically conducted for image-based diagnostic aids (e.g., AI for radiology) where human readers interpret medical images. This device is a lab-based immunoassay that provides a quantitative numerical result. Therefore, an MRMC study is not relevant or applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the entire study is essentially a standalone performance evaluation. The MAGLUMI 2000 HCG/ß-HCG is an automated chemiluminescence immunoassay system. Its performance characteristics (precision, linearity, detection limits, interference, hook effect, dilution recovery, and method comparison) are evaluated as the direct output of the instrument and its reagents, without explicit human interpretation being part of the device's function or the primary subject of these studies. The quantitative output of the device itself constitutes its "performance."

7. The Type of Ground Truth Used

The ground truth for this device's performance evaluation is established through:

• Reference Measurement Procedures/Known Concentrations: For studies like linearity, detection limits, and interference, known concentrations or "spiked" samples are used as a reference.
• Measurement against a Predicate Device: For the method comparison study, the results from the Beckman Access Total B-HCG (5th IS) Assay (the predicate device) served as the comparative "ground truth" to establish substantial equivalence.
• Statistical Analysis of Replicate Measurements: For precision, the statistical variation around the mean measured value for controls and patient samples provides the "ground truth" of the device's reproducibility.
• Physiological/Clinical Samples: For determining expected values/reference ranges, samples from apparently healthy individuals are used.

8. The Sample Size for the Training Set

The document does not explicitly describe a "training set" in the context of an algorithm or machine learning model. This is an in vitro diagnostic assay, not an AI/ML-based device that typically undergoes a distinct training/validation/test split of data. The studies described are analytical verification and validation studies in a traditional medical device development sense.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no defined "training set" for an AI/ML algorithm, this question is not relevant to the described device and its evaluation. The "training" of such a system would involve the manufacturer's internal assay development and optimization, which isn't part of a regulatory submission summary like this.

Ask a specific question about this device

The Atellica® IM Total hCG (ThCG) assay is for in vitro diagnostic use in the quantitative determination of human chorionic gonadotropin (hCG) in human serum or plasma (EDTA or lithium heparin) using the Atellica® IM Analyzer.

Human chorionic gonadotropin measurements are intended for use as an aid in the early detection of pregnancy.

The Atellica® IM Total hCG (ThCG) Assay reagents come in the following configurations:
1 ReadyPack primary reagent pack containing Atellica IM ThCG Lite Reagent and Solid Phase Atellica IM ThCG master curve and test definition (90 Tests)
5 ReadyPack primary reagent packs containing Atellica IM ThCG Lite Reagent and Solid Phase Atellica IM ThCG master curve and test definition (450 Tests)

The ReadyPack consists of the following:
Atellica IM ThCG ReadyPack primary reagent pack Lite Reagent: 4.5 mL/reagent pack Goat polyclonal anti-hCG antibody (~0.1 µg/mL) labeled with acridinium ester in buffered saline; sodium azide (0.1%); preservatives
Solid Phase: 20.3 mL/reagent pack Mouse monoclonal anti-hCG antibody (~0.02 mg/mL) covalently coupled to paramagnetic particles in buffered saline; sodium azide (0.1%); preservatives.
Atellica IM ThCG DIL ReadyPack ancillary reagent pack: 25.0 mL/pack Buffered heat-treated equine serum; EDTA; sodium azide (

Here's a breakdown of the acceptance criteria and study information for the Atellica® IM Total hCG (ThCG) device, based on the provided FDA 510(k) summary:

The purpose of this submission (K192790) is to add a plasma (EDTA and lithium heparin) sample claim for the Atellica® IM Total hCG (ThCG) assay, which was previously cleared for serum samples under K172322. Therefore, the acceptance criteria and supporting studies specifically address the performance of the device with these new sample types.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new plasma sample types are implicitly derived from the established performance of the predicate device with serum and are demonstrated through equivalency studies. The key performance indicator for this submission is the agreement between plasma and serum samples.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Specimen Equivalence (Test Set):

  • Dipotassium EDTA plasma: 116 samples
  • Lithium heparin plasma: 134 samples

• Sample Interval: 3.8 - 959.2 mIU/mL (IU/L) for both plasma types.

• Data Provenance: The document does not explicitly state the country of origin or whether the samples were retrospective or prospective.

• Sample Size for Interference (Test Set): Not explicitly stated, however, the results show bias at two analyte concentrations for each interferent, suggesting a controlled experimental setup, likely with replicates for each condition.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This type of immunoassay (quantitative determination of hCG) typically does not involve human experts establishing a subjective "ground truth" for individual test samples, as the analyte concentration is an objective biochemical measurement. The ground truth, in this context, is the measured hCG concentration in the serum samples, which essentially serves as the reference for comparison against plasma samples. The accuracy of these serum measurements would be ensured by laboratory quality controls and standardization against international reference materials (WHO 4th IS 75/589 reference material), as mentioned in the "Standardization" section. Therefore, no "experts" in the sense of clinical reviewers are used to establish ground truth for this type of quantitative assay performance study.

4. Adjudication Method for the Test Set

Not applicable. For a quantitative assay comparing different sample matrices, adjudication methods like N+1 consensus are not used. The comparison is statistical, based on linear regression and bias analysis between the results from the plasma samples and the reference serum samples.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic assay that quantitatively measures a biomarker (hCG). MRMC studies are typically performed for imaging devices or other diagnostic tools where human interpretation plays a role, to assess the impact of AI assistance on human reader performance. This submission focuses on the analytical performance of the assay itself with different sample types.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Yes, the performance studies described are standalone. The "device" in question is the Atellica® IM Total hCG (ThCG) assay, which is an automated in vitro diagnostic system. The performance data presented (specimen equivalence and interference) directly reflects the analytical performance of the assay when run on the Atellica® IM Analyzer, without human intervention in the measurement process itself, beyond standard laboratory procedures for sample handling and instrument operation.

7. The Type of Ground Truth Used

For the specimen equivalence study, the ground truth for comparison was the hCG concentration determined in human serum samples using the Atellica® IM Total hCG (ThCG) assay (the predicate device). The new sample types (EDTA plasma and lithium heparin plasma) were then tested on the same device and compared against these serum results.

For interference testing, the "ground truth" would be the expected hCG concentration in the samples without the interferent, or a known spiked concentration.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of this 510(k) submission. This is typical for in vitro diagnostic assays based on established immunoassay principles, where the assay design, calibration, and optimization (which can be analogous to "training" in AI/ML) would have been performed during the initial development and clearance of the predicate device (K172322). This submission is an extension of that device for new sample types, relying on the already established assay method.

9. How the Ground Truth for the Training Set was Established

As noted above, a distinct "training set" in the AI/ML sense is not directly applicable here. The "ground truth" for the development and establishment of the assay's performance would have involved:

• Standardization: Against the World Health Organization (WHO) 4th IS 75/589 reference material for hCG. This provides the fundamental "ground truth" reference for hCG concentration.
• Calibration: Assigned values for calibrators are traceable to this WHO standard.
• Analytical Performance Studies: Initial studies (precision, linearity, detection capability) performed for the predicate device (K172322) would have established the assay's performance characteristics against these standardized references and known concentrations.

Ask a specific question about this device