(44 days)
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No
The summary describes a reagent and its use on a specific family of clinical analyzers for quantitative determination of a substance. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
No
This device is an in vitro diagnostic reagent used to quantitatively measure valproic acid levels in human serum and plasma, which is for diagnostic purposes, not therapeutic intervention.
Yes
Explanation: The device is intended for the "quantitative determination of valproic acid in human serum and plasma," which is a measurement used to aid in the diagnosis, monitoring, or treatment of medical conditions.
No
The device description clearly states it is a "test system" and a "reagent" intended for use with specific hardware analyzers (SYNCHRON System analyzers). This indicates it includes physical components (reagents) and is designed to operate on specific hardware, not solely as software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "intended for use in the quantitative determination of valproic acid in human serum and plasma." This indicates the device is used to test samples taken from the human body (in vitro) to provide diagnostic information (determining the amount of valproic acid).
- Device Description: The description reinforces this by stating it's a "test system" for the "quantitative measurement of valproic acid in serum and plasma."
- Performance Studies: The inclusion of performance studies like "Method Comparison" and "Precision" are typical for IVD devices, demonstrating their analytical performance for diagnostic purposes.
- Predicate Device: The mention of a "Predicate Device" (K904226; TDxFLx® Valproic Acid Reagent) is a strong indicator that this device is being compared to an already cleared IVD device, a common practice in regulatory submissions for IVDs.
The core function of analyzing human biological samples (serum and plasma) to measure a specific substance (valproic acid) for diagnostic purposes clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SYNCHRON Systems Valproic Acid reagent in conjunction with the SYNCHRON Drug Calibrator 1 is intended for use in the quantitative determination of valproic acid in human serum and plasma. This assay is designed for use with the family of SYNCHRON System analyzers which include the SYNCHRON CX®4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.
Product codes
Not Classified, 21 CFR §862.1150
Device Description
The Beckman SYNCHRON Systems Valproic Acid (VPA) test system used in conjunction with the SYNCHRON Systems Drug Calibrator 1 is designed for optimal performance on the Beckman SYNCHRON family of clinical analyzers for the quantitative measurement of valproic acid in serum and plasma . The SYNCHRON family of clinical analyzers include the SYNCHRON CX®4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison:
Analyte: Valproic Acid
Slope: 1.0443
Intercept: 2.00
r: 0.9857
n: 104
Predicate: Abbott TDxFLx Valproic Acid Reagent
Precision (Valproic Acid (VPA) Imprecision Study Results Within Run Imprecision):
Sample: Low, Mean (µg/mL): 34.5, S.D. (µg/mL): 1.1, %C.V.: 3.1, N: 80
Sample: Mid-Range, Mean (µg/mL): 83.3, S.D. (µg/mL): 1.6, %C.V.: 2.0, N: 80
Sample: High, Mean (µg/mL): 131.3, S.D. (µg/mL): 3.1, %C.V.: 2.4, N: 80
Precision (Valproic Acid (VPA) Imprecision Study Results Total Imprecision):
Sample: Low, Mean (µg/mL): 34.5, S.D. (µg/mL): 1.6, %C.V.: 4.6, N: 80
Sample: Mid-Range, Mean (µg/mL): 83.3, S.D. (µg/mL): 3.1, %C.V.: 3.8, N: 80
Sample: High, Mean (µg/mL): 131.3, S.D. (µg/mL): 3.6, %C.V.: 2.7, N: 80
Analytic Range:
Analyte: Valproic Acid, Sample Type: Serum/Plasma, Measuring Range (µg/mL): 10-150, Assessment: Linear
Summary of Stability Data:
Reagent and Calibrator: Valproic Acid (VPA) Reagent, Findings: 24 Months (Reagent)
Reagent and Calibrator: Valproic Acid Calibrator (Drug Cal 1), Findings: 24 Months (Calibrator)
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the word "BECKMAN" in all capital letters. The letters are outlined in black, and the inside of the letters is a light gray color. The word is centered in the image and is the only element present.
Summary of Safety and Effectiveness Beckman Instruments, Inc. SYNCHRON Systems Valproic Acid (VPA) Reagent Section 510(k) Notification
MAY 1 5 1996
Image /page/0/Picture/4 description: The image shows a sequence of handwritten characters. The sequence starts with the letter 'K', followed by the numbers '961256'. The characters are written in a bold, dark font, which makes them stand out against the white background. The handwriting style appears somewhat casual.
1.0 Submitted By:
Paul Trujilo Sr. Regulatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Blvd. MS W337 Brea CA 92622-8000 Telephone: (714) 961-8760 FAX: (714) 961 4457
2.0 Date Submitted:
March 29, 1996
3.0 Device Name:
3.1 Proprietary Names:
SYNCHRON® Systems Valproic Acid (VPA) Reagent
SYNCHRON® Systems Drug Calibrator 1
3.2 Classification Names:
Valproic Acid Test System (Not Classified)
Calibrator (21 CFR §862.1150)
4.0 Predicate Devices:
PREDICATE DEVICE SELECTION
| SYNCHRON
| Systems Reagent | Predicate | Manufacturer | Docket Number |
|---|---|---|---|
| Valproic Acid | |||
| Reagent | TDxFLx®** Valproic | ||
| Acid Reagent | Abbott* | ||
| Laboratories, Inc. | K904226 |
*Abbott Laboratories, Abbott Park, IL 60064
** Trademark of Abbott Laboratories, Inc.
5.0 Description:
The Beckman SYNCHRON Systems Valproic Acid (VPA) test system used in conjunction with the SYNCHRON Systems Drug Calibrator 1 is designed for optimal performance on the Beckman SYNCHRON family of clinical analyzers for the quantitative measurement of valproic acid in serum and plasma . The SYNCHRON family of clinical analyzers include the SYNCHRON CX®4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.
1
6.0 Intended Use:
The SYNCHRON Systems Valproic Acid reagent in conjunction with the SYNCHRON Drug Calibrator 1 is intended for use in the quantitative determination of valproic acid in human serum and plasma. This assay is designed for use with the family of SYNCHRON System analyzers which include the SYNCHRON CX®4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.
7.0 Comparison to Predicate:
Method Comparison
| Analyte | Slope | Intercept | r | n | Predicate |
|---|---|---|---|---|---|
| Valproic Acid | 1.0443 | 2.00 | 0.9857 | 104 | Abbott TDxFLx Valproic |
| Acid Reagent |
8.0 Precision:
Valproic Acid (VPA) Imprecision Study Results Within Run Imprecision
| Sample | Mean (µg/mL) | S.D. (µg/mL) | %C.V. | N |
|---|---|---|---|---|
| Low | 34.5 | 1.1 | 3.1 | 80 |
| Mid-Range | 83.3 | 1.6 | 2.0 | 80 |
| High | 131.3 | 3.1 | 2.4 | 80 |
Valproic Acid (VPA) Imprecision Study Results
Total Imprecision
| Sample | Mean (µg/mL) | S.D. (µg/mL) | %C.V. | N |
|---|---|---|---|---|
| Low | 34.5 | 1.6 | 4.6 | 80 |
| Mid-Range | 83.3 | 3.1 | 3.8 | 80 |
| High | 131.3 | 3.6 | 2.7 | 80 |
2
Analytic Range:
| Analyte | Sample Type | Measuring Range (µg/mL) | Assessment |
|---|---|---|---|
| Valproic Acid | Serum/Plasma | 10-150 | Linear |
10.0
9.0
ﮨﮯ ﮨﮯ ﮨ
Summary of Stability Data:
| Reagent and Calibrator | Findings |
|---|---|
| Valproic Acid (VPA) Reagent | 24 Months (Reagent) |
| Valproic Acid Calibrator (Drug Cal 1) | 24 Months (Calibrator) |
This summary of safety and effectiveness is being submitted in compliance to the requirements of the Safe Medical Device Act and the implementing regulation 21 CFR క్ర807.92.