(45 days)
Not Found
No
The summary describes a reagent kit for a clinical chemistry analyzer and does not mention any AI or ML components. The performance studies focus on standard analytical validation metrics like method comparison and imprecision.
No
The device is a reagent for quantitative determination of total thyroxine concentrations and is used for diagnostic purposes, not therapeutic intervention.
Yes
The device is described as "intended for the quantitative determination of total thyroxine concentrations in serum," which is a measurement used to aid in clinical diagnosis.
No
The device description clearly states it is a "Reagent kit" which includes physical components (T4 Reagent and T4 Calibrators) intended for use on a clinical system. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of total thyroxine concentrations in serum". This indicates that the device is used to analyze a biological sample (serum) outside of the body (in vitro) to provide diagnostic information (thyroxine levels).
- Device Description: The description mentions a "Reagent kit" and "Calibrators" intended for use on "Clinical Systems". Reagents and calibrators are common components of IVD tests.
- Performance Studies: The document describes "Method Comparison Study Results" and "Estimated Imprecision", which are standard performance evaluations for IVD devices to demonstrate their accuracy and reliability in measuring analytes in biological samples.
- Predicate Device(s): The mention of predicate devices (other IVD tests for T4) further confirms that this device falls within the category of IVDs.
The core function of the device is to perform a test on a biological sample (serum) to measure a specific substance (thyroxine) for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SYNCHRON Systems Thyroxine (T4) Reagent is intended for the quantitative determination of total thyroxine concentrations in serum on SYNCHRON Clinical Systems.
Product codes (comma separated list FDA assigned to the subject device)
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Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The data in the Premarket Notification on safety and effectiveness support a finding of Equivalence for the SYNCHRON Systems Thyroxine (T4) Reagent to test systems already in commercial distribution. Equivalence is demonstrated through method comparison, imprecision studies, and SYNCHRON Systems Thyroxine Stability Studies that followed around Casino CEDIA MAb Thyroxine Reagent with a SYNCHRON Application.
Method Comparison Study Results SYNCHRON Systems T4 Reagent:
Analyte (Reagent): Thyroxine (T4)
Slope: 1.018
Intercept (μg/dL): 0.12
r: 0.992
n: 97
Predicate Method: Boehringer Mannheim CEDIA MAb Thyroxine Reagent
Estimated Imprecision SYNCHRON Systems T4 Reagent:
Within-Run Imprecision:
Level 1: Mean (ug/dL) 4.2; S.D. (ug/dL) 0.2; %C.V. 4.3; N 80
Level 2: Mean (ug/dL) 8.6; S.D. (ug/dL) 0.2; %C.V. 2.4; N 80
Level 3: Mean (ug/dL) 17.1; S.D. (ug/dL) 0.3; %C.V. 1.7; N 80
Total Imprecision:
Level 1: Mean (ug/dL) 4.2; S.D. (ug/dL) 0.4; %C.V. 8.8; N 80
Level 2: Mean (ug/dL) 8.6; S.D. (ug/dL) 0.4; %C.V. 4.3; N 80
Level 3: Mean (ug/dL) 17.1; S.D. (ug/dL) 0.4; %C.V. 2.4; N 80
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 | Docket
Number |
|--------------------------------------------|--------------------------------------------------|-------------------------------|------------------|
| SYNCHRON Systems
Thyroxine (T4) Reagent | CEDIA T4 MAb
Reagent | Boehringer Mannheim
Corp., | K935880 |
| SYNCHRON Systems
Thyroxine (T4) Reagent | CEDIA T4 MAb
Reagent- SYNCHRON
Application | Boehringer Mannheim
Corp., | K942575 |
1
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 |
|---|---|---|
| SYNCHRON | ||
| Systems Thyroxine | ||
| (T4) Reagent | Intended use | Same as the predicate |
| SYNCHRON | ||
| Systems Thyroxine | ||
| (T4) Reagent | Chemical Reaction | Same principle as the predicate |
| SYNCHRON | ||
| Systems Thyroxine | ||
| (T4) Reagent | Formulation | Same source, processing as |
| predicate | ||
| SYNCHRON | ||
| Systems Thyroxine | ||
| (T4) Reagent | Calibration | Same as the predicate |
| SYNCHRON | ||
| Systems Thyroxine | ||
| (T4) Reagent | Reagent Kit Configuration | Same as the predicate |
SIMILARITIES to the PREDICATE
DIFFERENCES from the PREDICATE
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SYNCHRON Systems | ||
| Thyroxine (T4) | ||
| Reagent | Specimen Type | SYNCHRON T4 Reagent claims |
| Sodium Heparin and Lithium | ||
| Heparin as acceptable | ||
| anticoagulants while the | ||
| Boehringer Mannheim CEDIA T4 | ||
| MAb Reagent claims Sodium | ||
| Heparin, Lithium Heparin, and | ||
| Sodium EDTA as acceptable | ||
| anticoagulants. |
2
2
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 Mannheim |
| CEDIA MAb Thyroxine | |||||
| Reagent |
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
| CHANGE CONSULTION COLLEGION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CON
.
THE CHARLES COLLEGE COLLECTION CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONSULTER CONSULTER CONSULTER CONSULTER CONSULTER CONSULTER
THE CALLER FREE PARTER COLLECT CALL CONSULT CONSULT CONSULT CONTRACT
While the contract to recommend in any any any any more the contraction of the control of the collection | and and the comments of the same of the summer of the stream of the states of the man
· man a = = = = = = = = = = = =====
Caracterial Comments of Comments of Comments of Construction Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comme
CALL A SECREEMENT LE LA LEGION LE LA A SA CARA A LA CARA A CARA A CARA A CARA A CARA A CARA A CARA A CARA A CARA A CARA A CARA A CARA A CARA A CARA A CARA A CARA A CARA A CAR |
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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.
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