(98 days)
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No
The summary describes chemical reagents and their performance characteristics, with no mention of AI or ML.
No
The device is described as reagents for quantitative determination of iron and total iron binding capacity in human serum and plasma, which are diagnostic measurements and not therapeutic.
Yes
The device is described as reagents intended for the "quantitative determination of iron and total iron binding capacity in human serum and plasma samples," which is a diagnostic measurement.
No
The device description clearly states it is a reagent, which is a chemical substance used in a chemical reaction, not a software program. It is intended for use with specific hardware systems (SYNCHRON Systems).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "quantitative determination of iron and total iron binding capacity in human serum and plasma samples." This involves testing biological samples in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details reagents used for performing these tests on biological samples.
- Performance Studies: The performance studies involve analyzing results obtained from testing samples, which is characteristic of IVD devices.
The core function of the device is to analyze biological samples to measure specific substances (iron and total iron binding capacity) for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SYNCHRON Systems Iron (FE) and Iron Binding Capacity (IBCT) Reagents, in conjunction with SYCNHRONC Systems Iron/TIBC Calibrator, are intended for use in the quantitative determination of iron and total iron binding capacity in human serum and plasma samples. These assays are designed for use with the family of SYNCHRON Systems such as the SYNCHRON CX®4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.
Product codes
862.1410, 862.1415
Device Description
The SYNCHRON Systems Iron (FE) and Total Iron Binding Capacity (IBCT) Reagents are modifications of the current SYNCHRON CX Systems Iron (IRON) and Total Iron Binding Capacity (TIBC) Reagents, and are designed for optimal performance on the SYNCHRON Systems. The modifications include formulation changes which allow for the assay of both serum and plasma samples. Additionally, the IBCT assay utilizes an alumina column for the removal of unbound ferric ions as opposed to magnesium carbonate.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The data In the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method companison, stability, and imprecision experiments that relate results obtained from the SYNCHRON FE and IBCT Reagents to the SYNCHRON CX IRON and TIBC Reagents.
Method Comparison Study Results:
Analyte: FE Reagent, Slope: 1.0158, Intercept: -0.92, r: 0.9998, Predicate: CX IRON Reagent
Analyte: IBCT Reagent, Slope: 1.0736, Intercept: -11.95, r: 0.9979, Predicate: CX TIBC Reagent
Stability Study Results:
FE Reagent: 24 months shelf-life, 30 days on-instrument, 14 day calibration
IBCT Reagent: 24 months shelf-life, 30 days on-instrument, 14 day calibration
Estimated Within-Run Imprecision:
FE Reagent:
Level 1: MEAN (ug/mL): 53.5, SD (ug/mL): 1.41, %CV: 2.6, Number of Results: 80
Level 2: MEAN (ug/mL): 166.5, SD (ug/mL): 2.61, %CV: 1.6, Number of Results: 80
Level 3: MEAN (ug/mL): 270.5, SD (ug/mL): 2.24, %CV: 0.8, Number of Results: 80
IBCT Reagent:
Level 1: MEAN (ug/mL): 148.2, SD (ug/mL): 7.8, %CV: 5.2, Number of Results: 80
Level 2: MEAN (ug/mL): 370.5, SD (ug/mL): 4.3, %CV: 1.2, Number of Results: 80
Level 3: MEAN (ug/mL): 448.2, SD (ug/mL): 8.7, %CV: 1.9, Number of Results: 80
Key Metrics
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Predicate Device(s)
SYNCHRON CX System Iron (IRON) Reagent, K870986, SYNCHRON CX Systems Total Iron Binding Capacity (TIBC) Reagent, K870986, J&S Medical Associates Micro Column, K893662
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1415 Iron-binding capacity test system.
(a)
Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.(b)
Classification. Class I (general 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
Summary of Safety & Effectiveness SYNCHRON Systems Iron (FE) & Total Iron Binding Capacity (IBCT) Reagents
1.0 Submitted By:
Sheri Hall Manager, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92621 Telephone: (714) 993-8916 FAX: (714) 961-4457
MAY 10 1996
2.0 Date Submitted:
31 December 1996
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON Systems Iron (FE) Reagent SYNCHRON Systems Total Iron Binding Capacity (IBCT) Reagent
3.2 Classification Names
Iron (non-heme) test system (21 CFR 862.1410) Iron-binding capacity test system (21 CFR 862.1415)
4.0 Predicate Device(s):
SYNCHRON CX System Iron (IRON) Reagent, K870986 SYNCHRON CX Systems Total Iron Binding Capacity (TIBC) Reagent, K870986 J&S Medical Associates Micro Column, K893662
5.0 Description:
The SYNCHRON Systems Iron (FE) and Total Iron Binding Capacity (IBCT) Reagents are modifications of the current SYNCHRON CX Systems Iron (IRON) and Total Iron Binding Capacity (TIBC) Reagents, and are designed for optimal performance on the SYNCHRON Systems. The modifications include formulation changes which allow for the assay of both serum and plasma samples. Additionally, the IBCT assay utilizes an alumina column for the removal of unbound ferric ions as opposed to magnesium carbonate.
6.0 intended Use:
The SYNCHRON Systems Iron (FE) and Iron Binding Capacity (IBCT) Reagents, in conjunction with SYCNHRONC Systems Iron/TIBC Calibrator, are intended for use in the quantitative determination of iron and total iron binding capacity in human serum and plasma samples. These assays are designed for use with the family of SYNCHRON Systems such as the SYNCHRON CX®4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.
EBECHINDIK JIGGEN MINERES, ROC..
1
7.0 Comparison to Predicate(s):
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SIMILARITIES | ||
| FE Reagent | Timed endpoint reaction using | |
| FerroZine Iron Reagent* | Same as SYNCHRON IRON | |
| Reagent | ||
| 2-year shelf-life, 30-day open | ||
| bottle, 14-day calibration stability | Same as SYNCHRON IRON | |
| Reagent | ||
| Analytic range 5-500 and within- | ||
| run imprecision claim of 2.5% CV | Same as SYNCHRON IRON | |
| Reagent | ||
| IBCT Reagent | Supernatant from transferrin | |
| saturation is measured by | ||
| FerroZine Iron Reagent reaction | Same as SYNCHRON TIBC | |
| Reagent | ||
| 2-year shelf-life, 30-day open | ||
| bottle, 14-day calibration stability | Same as SYNCHRON TIBC | |
| Reagent | ||
| Analytic range 10-1000 and | ||
| within-run imprecision claim of | ||
| 4% CV | Same as SYNCHRON TIBC | |
| Reagent | ||
| DIFFERENCES | ||
| FE Reagent | Sample type for assay | FE reagent modified to |
| utilize serum and plasma | ||
| samples | ||
| IBCT Reagent | Sample type for assay | IBCT reagent modified to |
| utilize serum and plasma | ||
| samples | ||
| Sample preparation | IBCT reagent utilizes | |
| alumina columns for | ||
| removal of unbound ferric | ||
| ion |
- FerroZine Reagent is a trademark of Hach Chemical Co.
8.0 Summary of Performance Data:
The data In the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method companison, stability, and imprecision experiments that relate results obtained from the SYNCHRON FE and IBCT Reagents to the SYNCHRON CX IRON and TIBC Reagents.
Method Comparison Study Results SYNCHRON FE & IBCT Reagents vs. SYNCHRON IRON & TIBC Reagents
| Analyte | Slope | Intercept | r | Predicate |
|---|---|---|---|---|
| FE Reagent | 1.0158 | -0.92 | 0.9998 | CX IRON |
| Reagent | ||||
| IBCT Reagent | 1.0736 | -11.95 | 0.9979 | CX TIBC |
| Reagent |
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મ્દ્
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Stability Study Results
| Reagent | Product Claim |
|---|---|
| FE Reagent | 24 months shelf-life |
| 30 days on-instrument | |
| 14 day calibration | |
| IBCT Reagent | 24 months shelf-life |
| 30 days on-instrument | |
| 14 day calibration |
Estimated Within-Run Imprecision
| MATERIAL | MEAN (ug/mL) | SD (ug/mL) | %CV | Number of Results |
|---|---|---|---|---|
| FE Reagent | ||||
| Level 1 | 53.5 | 1.41 | 2.6 | 80 |
| Level 2 | 166.5 | 2.61 | 1.6 | 80 |
| Level 3 | 270.5 | 2.24 | 0.8 | 80 |
| IBCT Reagent | ||||
| Level 1 | 148.2 | 7.8 | 5.2 | 80 |
| Level 2 | 370.5 | 4.3 | 1.2 | 80 |
| Level 3 | 448.2 | 8.7 | 1.9 | 80 |
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.