(45 days)
The SYNCHRON Systems Thyroxine (T4) Reagent is intended for the quantitative determination of total thyroxine concentrations in serum on SYNCHRON Clinical Systems.
The SYNCHRON Systems Thyroxine (T4) Reagent kit, which includes the T4 Reagent and the T4 Calibrators, in intended for use on Beckman's SYNCHRON Clinical Systems.
Here's an analysis of the provided text regarding the SYNCHRON Systems Thyroxine (T4) Reagent, focusing on acceptance criteria and supporting studies:
This document is a 510(k) Summary of Safety & Effectiveness for an in vitro diagnostic device, not a medical imaging AI device. Therefore, many of the requested fields (like the number of experts, adjudication methods, MRMC studies, standalone performance for AI, training set details) are not applicable to this type of submission. The 'ground truth' in this context refers to the true concentration of T4 in a sample, which is established by comparison to a legally marketed predicate device.
Acceptance Criteria and Device Performance for SYNCHRON Systems Thyroxine (T4) Reagent
1. Table of Acceptance Criteria and Reported Device Performance
For in vitro diagnostic devices like this, the primary acceptance criteria revolve around demonstrating equivalence to a legally marketed predicate device through method comparison, imprecision, and stability. While explicit numerical acceptance criteria are often present in the full submission, this summary provides the performance results that are implicitly compared against such criteria to demonstrate equivalence.
| Performance Metric | Acceptance Criteria (Implied for Equivalence) | Reported Device Performance |
|---|---|---|
| Method Comparison | Slope: Close to 1.0 Intercept: Close to 0 Correlation Coefficient (r): High (e.g., >0.95 or >0.98) | Slope: 1.018 Intercept: 0.12 µg/dL r: 0.992 |
| Imprecision (Within-Run) | %C.V. should be within acceptable limits for diagnostic assays (e.g., typically <10% for many assays, especially at lower concentrations, and improving at higher concentrations). | Level 1: 4.3% C.V. Level 2: 2.4% C.V. Level 3: 1.7% C.V. |
| Imprecision (Total) | %C.V. should be within acceptable limits for diagnostic assays (slightly higher than within-run, but still demonstrating good reproducibility). | Level 1: 8.8% C.V. Level 2: 4.3% C.V. Level 3: 2.4% C.V. |
| On-Board Stability | Reagent performance (e.g., accuracy, precision) remains within specifications for the claimed stability period. | Study conducted, but specific quantitative results not provided in this summary. Stated simply as "Stablity Studies that folder round Casino CEDIA MAb Thyroxine Reagent with a SYNCHRON Application." |
2. Sample Size Used for the Test Set and the Data Provenance
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Method Comparison (Test Set):
- Sample Size: N = 97 samples
- Data Provenance: Not explicitly stated (e.g., country of origin). It's reasonable to infer these would be human serum samples collected for clinical testing purposes. The study is retrospective in the sense that the samples are tested by both methods simultaneously or sequentially to compare results.
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Imprecision Study (Test Set):
- Sample Size: N = 80 replicates per level (Level 1, Level 2, Level 3). This is typically 2 replicates per run over 20 runs, or similar design.
- Data Provenance: Not explicitly stated. These would be control materials or pooled human serum samples at different T4 concentrations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- N/A. This is an in vitro diagnostic device. The "ground truth" for the test set is established by the predicate device (Boehringer Mannheim CEDIA MAb Thyroxine Reagent), which is a legally marketed and presumably well-validated T4 assay. There are no "experts" establishing ground truth in the sense of reviewing images or clinical cases.
4. Adjudication Method for the Test Set
- N/A. This concept is not applicable to a chemical assay where results are quantitative values. The "adjudication" is essentially the comparison of the SYNCHRON T4 results to the predicate device's results.
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
- N/A. This is an in vitro diagnostic device, not an AI software or imaging device. There are no human "readers" involved in interpreting the results beyond reading the numerical output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, effectively. The performance data presented (method comparison, imprecision) represents the standalone performance of the SYNCHRON Systems Thyroxine (T4) Reagent and SYNCHRON Clinical System. It is an automated assay; there is no "human-in-the-loop" once the sample is loaded and the assay initiated, beyond quality control monitoring and result review.
7. The Type of Ground Truth Used
- Predicate Device Comparison. The "ground truth" for demonstrating equivalence is the results obtained from the Boehringer Mannheim CEDIA MAb Thyroxine Reagent, which is the legally marketed predicate device. This is a common strategy for 510(k) submissions of in vitro diagnostic tests.
8. The Sample Size for the Training Set
- N/A. This document describes a chemical reagent for an automated assay. There is no concept of a "training set" in the context of machine learning, as this device does not utilize AI/ML. The product itself (reagent, calibrators) is developed and manufactured, then validated against predicate devices and performance specifications.
9. How the Ground Truth for the Training Set Was Established
- N/A. As above, there is no training set as this is not an AI/ML device.
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Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON Systems Thyroxine (T4) Reagent Summary of Safety & Effectiveness
K971203 MAY 16 1997
Summary of Safety & Effectiveness SYNCHRON Systems Thyroxine (T4) Reagent 出
1.0 Submitted By:
Lucinda Stockert Senior Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4457
Date Submitted: 2.0
7 May 1997
Device Name(s): 3.0
3.1 Proprietary Names
SYNCHRON® Systems Thyroxine (T4) Reagent
3.2 Classification Name
Total thyroxine test system (21 CFR § 862.1700)
4.0 Predicate Device(s):
| SYNCHRON Reagent | Predicate | Predicate Company | DocketNumber |
|---|---|---|---|
| SYNCHRON SystemsThyroxine (T4) Reagent | CEDIA T4 MAbReagent | Boehringer MannheimCorp., | K935880 |
| SYNCHRON SystemsThyroxine (T4) Reagent | CEDIA T4 MAbReagent- SYNCHRONApplication | Boehringer MannheimCorp., | K942575 |
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5.0 Description:
The SYNCHRON Systems Thyroxine (T4) Reagent kit, which includes the T4 Reagent and the T4 Calibrators, in intended for use on Beckman's SYNCHRON Clinical Systems.
6.0 Intended Use:
The SYNCHRON Systems Thyroxine (T4) Reagent is intended for the quantitative determination of total thyroxine concentrations in serum on SYNCHRON Clinical Systems.
7.0 Comparison to Predicate(s):
The following tables show similarities and differences between the predicates identified in Section 4.0 of this summary.
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SYNCHRONSystems Thyroxine(T4) Reagent | Intended use | Same as the predicate |
| SYNCHRONSystems Thyroxine(T4) Reagent | Chemical Reaction | Same principle as the predicate |
| SYNCHRONSystems Thyroxine(T4) Reagent | Formulation | Same source, processing aspredicate |
| SYNCHRONSystems Thyroxine(T4) Reagent | Calibration | Same as the predicate |
| SYNCHRONSystems Thyroxine(T4) Reagent | Reagent Kit Configuration | Same as the predicate |
SIMILARITIES to the PREDICATE
DIFFERENCES from the PREDICATE
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SYNCHRON SystemsThyroxine (T4)Reagent | Specimen Type | SYNCHRON T4 Reagent claimsSodium Heparin and LithiumHeparin as acceptableanticoagulants while theBoehringer Mannheim CEDIA T4MAb Reagent claims SodiumHeparin, Lithium Heparin, andSodium EDTA as acceptableanticoagulants. |
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Summary of Performance Data: 8.0
The data in the Premarket Notification on safety and effectiveness support a finding of The uata in the I temanot Notmonton test systems already in commercial distribution. Equivalence is demonstrated through method companison, imprecision studies, and Equivalence is demonstrated through monton SYNCHRON Systems Thyroxine Stablity Stadies that folder round Casino CEDIA MAb Thyroxine Reagent with a SYNCHRON Application.
Method Comparison Study Results SYNCHRON Systems T4 Reagent
| Analyte (Reagent) | Slope | Intercept (μg/dL) | r | n | Predicate Method |
|---|---|---|---|---|---|
| Thyroxine (T4) | 1.018 | 0.12 | 0.992 | 97 | Boehringer MannheimCEDIA MAb ThyroxineReagent |
Estimated Imprecision SYNCHRON Systems T4 Reagent
| Sample | Mean (ug/dL) | S.D. (ug/dL) | %C.V. | N |
|---|---|---|---|---|
| Within-Run Imprecision | ||||
| Level 1 | 4.2 | 0.2 | 4.3 | 80 |
| Level 2 | 8.6 | 0.2 | 2.4 | 80 |
| Level 3 | 17.1 | 0.3 | 1.7 | 80 |
| Total Imprecision | ||||
| Level 1 | 4.2 | 0.4 | 8.8 | 80 |
| Level 2 | 8.6 | 0.4 | 4.3 | 80 |
| Level 3 | 17.1 | 0.4 | 2.4 | 80 |
On-Board Stability Study Results
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This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
15 1182
§ 862.1700 Total thyroxine test system.
(a)
Identification. A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.