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The Elecsys T3 CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys T3 quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.

The Elecsys T3 CalCheck 5 is a lyophilized product consisting of T3 in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

The provided text describes the Elecsys T3 CalCheck 5, an assayed control for use in calibration verification and assay range verification on Elecsys and cobas e immunoassay analyzers. However, the document provided is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data in the format requested.

Therefore, much of the requested information, such as detailed acceptance criteria with reported device performance values, sample sizes for test and training sets, expert qualifications, and specific study designs (MRMC, standalone), is not explicitly available in this summary.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

   The document does not explicitly state acceptance criteria in the format of a typical performance study. Instead, it compares the characteristics of the candidate device (Elecsys T3 CalCheck 5) with a predicate device (Elecsys T3 CalCheck, K963167) to demonstrate substantial equivalence.

   The "Performance Characteristics" section only states: "The Elecsys T3 CalCheck 5 was evaluated for value assignment and stability." It does not provide the results of these evaluations or specific acceptance criteria for them.

   Characteristic	Elecsys T3 CalCheck 5 (Candidate Device)	Elecsys T3 CalCheck (K963167)	Acceptance Criteria (not explicitly stated in document)	Reported Device Performance (not explicitly stated in document)
   Intended Use	Assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys T3 quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers.	For use in the verification of the calibration established by the Elecsys T3 regent on indicated Elecsys and cobas e immunoassay analyzers.	Equivalent to predicate	Equivalent
   Analyte	T3	T3	Identical to predicate	Identical
   Levels	Five	Three	Acceptable difference	Five levels
   Assay Measuring Range	0.300 - 10.0 nmol/L	0.300 - 10.0 nmol/L	Identical to predicate	Identical
   Check Target Values	Check 1: ≤ 0.2 nmol/L

Check 2: 2.0 nmol/L
Check 3: 5 nmol/L
Check 4: 8 nmol/L
Check 5: 10 nmol/L | Check 1: 0 ng/ml
Check 2: 1.6 ng/ml
Check 3: 5.8 ng/ml | Within expected range | Specified values |
| Format | Lyophilized | Lyophilized | Identical to predicate | Identical |
| Handling | Reconstitute with 1.0 mL distilled or deionized water, stand 15 minutes, mix gently. | Reconstitute with 1.0 mL distilled or deionized water, stand 15 minutes, mix gently. | Equivalent to predicate | Equivalent |
| Stability (Unopened) | Store at 2-8°C until expiration date | Store at 2-8°C until expiration date | Identical to predicate | Identical |
| Stability (Reconstituted) | 20-25°C: 4 hours | 15-25°C: 4 hours | Within acceptable range | 20-25°C: 4 hours |
| Matrix | Human serum matrix | Human serum matrix | Identical to predicate | Identical |

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

   This information is not provided in the 510(k) summary. The document mentions "value assignment and stability" evaluations but does not detail the methodology, sample sizes, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   This is not applicable as the device is a quality control material for an immunoassay, not an AI/imaging device requiring expert interpretation for ground truth.

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

   Not applicable for this type of device and study description.

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 a quality control material, not an AI-assisted diagnostic tool.

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

   Not applicable. This device is a quality control material, not an algorithm. The "performance" here refers to the chemical and physical characteristics of the control material (value assignment, stability) rather than diagnostic accuracy.

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

   For a quality control material, the "ground truth" for value assignment would typically be established through reference methods or highly calibrated and validated primary assays on the manufacturing end. The document does not specify the exact methods for value assignment, only that it was "evaluated for value assignment."

8. The sample size for the training set

   Not applicable. This device is a quality control material, not an AI model that requires a training set.

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

   Not applicable.

In summary, the provided 510(k) document is for a medical device (a quality control material) that does not involve AI or human interpretation in the way that would necessitate the study details requested in questions 2-9. Its clearance is based on substantial equivalence to a predicate device, focusing on similar intended use, analyte, matrix, and performance characteristics (which are not fully detailed in this summary). The "studies" mentioned refer to evaluations of the product's physicochemical properties (value assignment and stability) rather than clinical performance or diagnostic accuracy.

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For the in vitro quantitative determination of total triiodothyronine (T3) in human serum and plasma.

The Elecsys® T3 employs a competitive test principle with polyclonal antibodies directed against T3 and with streptavidin microparticles and electrochemiluminescence detection. Total duration of assay: 18 minutes.
• 1st Incubation: Sample (30 µl) and specific anti-T3 antibodies labeled with a ruthenium complex together with ANS to release T3 from serum.
• 2nd Incubation: After the addition of streptavidin-coated microparticles and biotinylated T3, the still-free binding sites of the labeled antibody become occupied, with formation of an antibody-hapten complex. The entire complex is bound to the solid phase via interaction of biotin and streptavidin.
• The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.
• Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.

Here's a summary of the acceptance criteria and study information for the Elecsys T3 device, based on the provided 510(k) summary:

The document does not explicitly state "acceptance criteria" in a pass/fail format, but rather presents performance characteristics of the new device (Elecsys T3) and compares them to a predicate device (Enzymun-Test® T3). The implicit acceptance criteria appear to be substantial equivalence, demonstrated by similar performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

vs. Enzymun-Test T3 (Cat. # 1135287):
Least Squares: N = 55, y = 1.13x + 0.02, r = 0.994 | (This section compares the new device to the predicate, so the predicate itself isn't a comparison target here, but the data it generated is used for comparison) | Correlation coefficients (r) close to 1, and slope (x) close to 1 with intercept (y) close to 0, indicating strong agreement between the new device and the predicate. The reported 'r' values of 0.957 and 0.994 suggest very good correlation. |
| Interfering Substances | Hemoglobin: 1 g/dl
Lipemia: 1500 mg/dl
Bilirubin: 25 mg/dl
Biotin: 20 ng/ml | Hemoglobin: 1 g/dl
Lipemia: 1250 mg/dl
Bilirubin: 65 mg/dl
Biotin: 50 ng/ml | Acceptable levels of interference for common substances. Elecsys T3 shows comparable or improved tolerance for some interferents (e.g., lipemia) and slightly lower tolerance for others (bilirubin, biotin), but within a clinically acceptable range as demonstrated by the predicate. |
| Specificity (% cross-reaction) | D-T3: 98.9%, L-T4: 0.115%, D-T4: 0.115%, L-rT3: 0.007%, L-T2: 0.998%, 3,3',5-tri-iodothyroacetic acid: 106.4%, 3,3',5,5'-tetra-iodothyroacetic acid: 0.007% | D-T3: 100%, L-T4: 0.16%, D-T4: 0.07%, L-rT3: 0.04%, L-T2: 1.0%, 3,3',5-tri-iodothyroacetic acid: 7.5%, 3,3',5,5'-tetra-iodothyroacetic acid: 0.01% | High specificity for T3 and low cross-reactivity with related substances, comparable to the predicate. The values are very close, indicating similar performance. |

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

The document does not explicitly define a "test set" in the context of an AI/algorithm-driven device. Instead, it describes performance characteristics determined through various studies.

• Precision Studies (NCCLS modified EP5-T2 for Elecsys T3, Modified NCCLS "Midi" EP3-T for Enzymun-Test T3):
  • Elecsys T3 Sample Size (N): 60 for each of the 5 samples (PC U1, PC U2, HS1, HS2, HS3). This suggests 60 replicates or measurements per sample, likely conducted over multiple runs/days as indicated by "total run % CV".
  • Enzymun-Test® T3 Sample Size (N): 118, 120, 117 for 3 different samples.
• Method Comparison Studies:
  • Elecsys T3 vs. Enzymun-Test T3 (Cat. # 1360868): N = 300
  • Elecsys T3 vs. Enzymun-Test T3 (Cat. # 1135287): N = 55
• Data Provenance: Not explicitly stated, but clinical studies for such devices typically involve human serum and plasma samples. The specific country of origin or whether the data was retrospective or prospective is not provided. It's common for these types of studies to be prospective, collecting samples specifically for the validation.

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

This device is an in vitro diagnostic (IVD) assay for quantitative determination of a hormone, not an imaging or diagnostic algorithm that relies on expert interpretation for ground truth. Therefore, there were no "experts" establishing ground truth in the traditional sense for a test set typically associated with AI/ML devices. The "ground truth" for quantitative assays is established by the reference method or by comparing against a well-established predicate device, which is what was done here.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is a quantitative assay, and ground truth is based on measurements and comparison to a predicate device, not expert adjudication of cases.

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 analyzer (an automated assay), not an AI-powered image analysis or diagnostic aid requiring human readers for interpretation. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant.

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

The device itself is a standalone algorithm/assay in its operation. The Elecsys T3 system performs the measurement and provides a quantitative result. There is no human "in the loop" during the primary measurement process beyond loading samples and reagents, and interpreting the final quantitative value. The performance characteristics described (precision, sensitivity, assay range, method comparison, interfering substances, specificity) are all measures of its standalone analytical performance.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation is primarily:

• Reference measurements/Predicate Device Comparison: The performance of the Elecsys T3 was compared directly against a legally marketed predicate device, the Enzymun-Test® T3. This comparison (method comparison studies) serves as the primary ground truth for demonstrating substantial equivalence.
• Defined concentrations/standards: For precision, sensitivity, and assay range, the "ground truth" comes from precisely prepared samples with known concentrations (e.g., control samples, diluted samples).
• Interfering substances/specificity panels: For these studies, the ground truth is the presence of known interfering substances or related compounds at specific concentrations, allowing the device's response to be assessed.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This is a traditional IVD device, not an AI/ML diagnostic. The development of such assays involves extensive R&D and optimization, but not typically a "training set" like in deep learning.

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

Not applicable, as there is no "training set" in the AI/ML sense for this traditional IVD device. The development process would rely on biochemical principles, empirical optimization, and validation against established reference methods or predicate devices.

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