(54 days)
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No
The document describes a standard in vitro diagnostic (IVD) reagent and calibrator for quantitative determination of digoxin, with performance studies focused on method comparison and imprecision, typical of chemistry analyzers. There is no mention of AI or ML.
No.
The device is intended for the quantitative determination of total digoxin in human serum or plasma, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is intended for the "quantitative determination of total digoxin in human serum or plasma," which is a measurement used to aid in the diagnosis and management of patients.
No
The device is a reagent and calibrator intended for use with specific hardware systems (Beckman SYNCHRON® Systems), indicating it is a component of a larger hardware-based diagnostic system, not a standalone software-only device.
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 total digoxin in human serum or plasma". This involves testing biological samples (serum or plasma) outside of the body (in vitro).
- Device Description: The description reinforces that it's for the "quantitative determination of Digoxin in human serum or plasma".
- Performance Studies: The performance studies involve analyzing samples (serum) and comparing results to a predicate method, which is typical for IVD devices.
The core function of the device is to analyze a biological sample (serum or plasma) to measure a substance (digoxin) within that sample, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SYNCHRON® Systems Digoxin (DIGN) Reagent, when used in conjunction with Beckman SYNCHRON® Systems and SYNCHRON® Systems Drug Calibrator 2 set, is intended for the quantitative determination of total digoxin in human serum or plasma on SYNCHRON® Systems.
The SYNCHRON® Systems Drug Calibrator 2, used in conjunction with SYNCHRON® Digoxin reagent, is intended for use on Beckman's SYNCHRON Systems for the calibration of Digoxin test systems.
Product codes (comma separated list FDA assigned to the subject device)
KXT, DLJ
Device Description
The SYNCHRON System Digoxin (DIGN) Reagent is designed for optimal performance on the SYNCHRON CX and LX Systems. It is intended for use in the quantitative determination of Digoxin in human serum or plasma.
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)
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 comparison, and imprecision experiments.
Method Comparison Study Results:
- SYNCHRON CX System (serum): Slope 1.053, Intercept (ng/mL) -0.03, r 0.991, n 113, Predicate Method Abbott TDx Digoxin II
- SYNCHRON LX System (serum): Slope 1.054, Intercept (ng/mL) -0.06, r 0.990, n 112, Predicate Method Abbott TDx Digoxin II
Estimated Within-Run Imprecision:
- CX System: Level 1 Mean 0.74 (ng/mL), S.D. 0.05 (ng/mL), %C.V. 6.96, N 80; Level 2 Mean 1.73 (ng/mL), S.D. 0.06 (ng/mL), %C.V. 3.29, N 80; Level 3 Mean 2.48 (ng/mL), S.D. 0.05 (ng/mL), %C.V. 1.80, N 80.
- LX System: Level 1 Mean 0.80 (ng/mL), S.D. 0.05 (ng/mL), %C.V. 6.06, N 80; Level 2 Mean 1.78 (ng/mL), S.D. 0.03 (ng/mL), %C.V. 1.78, N 80; Level 3 Mean 2.49 (ng/mL), S.D. 0.07 (ng/mL), %C.V. 2.62, 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.
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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).
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§ 862.3320 Digoxin test system.
(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.
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1 1 4 100
Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black circle on the left, with two curved white lines running through it. To the right of the circle is the company name, "BECKMAN COULTER," written in bold, black, sans-serif font. The word "BECKMAN" is stacked on top of the word "COULTER."
Summary of Safety & Effectiveness SYNCHRON® Systems Digoxin (DIGN) Reagent
1.0 Submitted By:
Lucinda Stockert Staff Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4123
2.0 Date Submitted:
August 19, 1998
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® Systems Digoxin (DIGN) Reagent SYNCHRON® Systems Drug Calibrator 2
Classification Name 3.2
Digoxin (21CFR §862.3320) Calibrator (21 CFR §862.3200)
4.0 Predicate Device(s):
| SYNCHRON Systems
Reagent | Predicate | Manufacturer | Docket
Number |
|----------------------------------------|-------------------|------------------------------|------------------|
| SYNCHRON®
Systems Digoxin
(DIGN) | TDx®** Digoxin II | Abbott* Laboratories,
Inc | K882233 |
*Abbott Laboratories, Abbott Park, IL 60064 **Trademark of Abbott Laboratories
5.0 Description:
The SYNCHRON System Digoxin (DIGN) Reagent is designed for optimal performance on the SYNCHRON CX and LX Systems. It is intended for use in the quantitative determination of Digoxin in human serum or plasma.
1
6.0 Intended Use:
The SYNCHRON® Systems Digoxin (DIG) Reagent, when used in conjunction with Beckman SYNCHRON® Systems and SYNCHRON® Systems Drug Calibrator 2 set, is intended for the quantitative determination of total digoxin in human serum or plasma on SYNCHRON® Systems.
The SYNCHRON® Systems Drug Calibrator 2, used in conjunction with SYNCHRON® Digoxin reagent, is intended for use on Beckman's SYNCHRON Systems for the calibration of Digoxin test systems.
7.0 Comparison to Predicate(s):
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| SIMILARITIES | ||
|---|---|---|
| SYNCHRON® | ||
| Systems Digoxin | ||
| (DIGN) | Intended use. | Same as Abbott TDx |
| Digoxin II Reagent | ||
| Liquid stable reagents. | ||
| Multipoint Calibration Scheme | ||
| Reagent measures digoxin in | ||
| both human plasma and | ||
| serum samples | ||
| DIFFERENCES | ||
| SYNCHRON® | ||
| Systems Digoxin | ||
| (DIGN) | SYNCHRON DIGN utilizes | |
| turbidimetric inhibition | ||
| immunoassay | Abbott TDx Digoxin reagent | |
| utilizes fluorescence | ||
| polarization immunoassay | ||
| Antibody source for | ||
| SYNCHRON DIGN is mouse. | Antisera source for TDx | |
| Digoxin II is rabbit. | ||
| Sample Pretreatment | SYNCHRON Systems DIGN | |
| does not require sample | ||
| pretreatment while the | ||
| predicate requires sample | ||
| pretreatment |
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 comparison, and imprecision experiments.
| SYNCHRON
DIGN Reagent | Sample
Type | Slope | Intercept
(ng/mL) | r | n | Predicate
Method |
|--------------------------|----------------|-------|----------------------|-------|-----|--------------------------|
| SYNCHRON
CX System | serum | 1.053 | -0.03 | 0.991 | 113 | Abbott TDx
Digoxin II |
| SYNCHRON
LX System | serum | 1.054 | -0.06 | 0.990 | 112 | Abbott TDx
Digoxin II |
Method Comparison Study Results
2
| SYNCHRON
System | Sample | Mean
(ng/mL) | S.D. (ng/mL) | %C.V. | N |
|--------------------|---------|-----------------|--------------|-------|----|
| | Level 1 | 0.74 | 0.05 | 6.96 | 80 |
| CX | Level 2 | 1.73 | 0.06 | 3.29 | 80 |
| | Level 3 | 2.48 | 0.05 | 1.80 | 80 |
| | Level 1 | 0.80 | 0.05 | 6.06 | 80 |
| LX | Level 2 | 1.78 | 0.03 | 1.78 | 80 |
| | Level 3 | 2.49 | 0.07 | 2.62 | 80 |
Estimated Within-Run Imprecision
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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure composed of three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 4 1998
Lucinda Stockert . Staff Regulatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Boulevard, M/S W-104 P.O. Box 8000 Brea, California 92822-8000
Re : K982935 SYNCHRON® Systems Digoxin Reagent Requlatory Class: II Product Code: KXT, DLJ Dated: August 19, 1998 Received: August 21, 1998
Dear Ms. Stockert:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set torth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Sitman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
page of
510(k) Number (if known)
510(k) Number (if known):
Device Name: SYNCHRON® Systems Digoxin (DIGN) Reagent
Indications for Use:
The SYNCHRON® Systems Digoxin (DIGN) Reagent, when used in conjunction with Beckman SYNCHRON® Systems and SYNCHRON® Systems Drug Calibrator 2 set, is intended for the quantitative determination of total digoxin in human serum or plasma on SYNCHRON® Systems.
The SYNCHRON® Systems Drug Calibrator 2, used in conjunction with SYNCHRON® Digoxin reagent, is intended for use on Beckman's SYNCHRON Systems for the calibration of Digoxin test systems.
Clinical Significance:
Digoxin is administered for conditions of heart failure or in the treatment of certain Digoxin therapy is monitored for possible toxicity and cardiac arrhythmias. inadequate therapeutic response.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE. ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off Division of Clinical Laboratory D 510(k) Number. Prescription Use OR Over-the-Counter Use (per 21 CFR 801.109) Optional Format 1-2-96