K Number
K983151
Device Name
IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT
Date Cleared
1998-11-05

(57 days)

Product Code
Regulation Number
862.3320
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IMMAGE® Immunochemistry System Digoxin (DIG) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and IMMAGE® Immunochemistry Systems Drug Calibrator 2, is intended for the quantitative determination of digoxin in human serum or plasma by turbidimetric immunoassay. The IMMAGE® Immunochemistry Systems Drug Calibrator 2, used in conjunction with IMMAGE® Digoxin reagent, is intended for use on Beckman Coulter's IMMAGE® Immunochemistry Systems for the calibration of digoxin test systems.
Device Description
The IMMAGE® Immunochemistry System Digoxin (DIG) Reagent is designed for optimal performance on the IMMAGE® Immunochemistry Systems. It is intended for the quantitative determination of Digoxin in serum and plasma.
More Information

Not Found

No
The summary describes a turbidimetric immunoassay reagent and system for quantitative determination of digoxin, with performance evaluated through standard method comparison and imprecision studies. There is no mention of AI or ML.

No
This device is an in-vitro diagnostic (IVD) reagent used for the quantitative determination of digoxin in biological samples, primarily for monitoring drug levels rather than directly treating a condition.

Yes

The device is intended for the "quantitative determination of digoxin in human serum or plasma," which is a measurement used to provide information for diagnosis or treatment.

No

The device description clearly states it is a reagent intended for use on an immunochemistry system, which is a hardware device. The summary focuses on the performance of the reagent in conjunction with the system, not on standalone software functionality.

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 digoxin in human serum or plasma by turbidimetric immunoassay." This involves testing biological samples (serum or plasma) outside of the body (in vitro) to provide diagnostic information (the amount of digoxin).
  • Device Description: The description reinforces that it's for the "quantitative determination of Digoxin in serum and plasma," again highlighting the in vitro testing of biological samples.
  • Performance Studies: The performance studies describe method comparison and imprecision experiments using serum samples, which are typical evaluations for IVD devices.
  • Predicate Device: The mention of a "Predicate Method: Abbott TDx Digoxin II" indicates that this device is being compared to another device already on the market for the same diagnostic purpose, which is common in the regulatory process for IVDs.

The core function of the device is to analyze a biological sample (serum or plasma) in a laboratory setting to measure a specific substance (digoxin) for diagnostic purposes. This aligns perfectly with the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The IMMAGE® Immunochemistry System Digoxin (DIG) Reagent, when used in conjunction with Beckman IMMAGE® Immunochemistry Systems and Beckman Drug Calibrator 2, is intended for the quantitative determination of digoxin in human serum or plasma by turbidimetric immunoassay.
Clinical Significance:
Digoxin is administered for conditions of heart failure or in the treatment of certain cardiac arrhythmias. Digoxin therapy is monitored for possible toxicity and inadequate therapuetic response.

Product codes (comma separated list FDA assigned to the subject device)

KXT

Device Description

The IMMAGE® Immunochemistry System Digoxin (DIG) Reagent is designed for optimal performance on the IMMAGE® Immunochemistry Systems. It is intended for the quantitative determination of Digoxin in serum and plasma.

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

Not Found

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

Not Found

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Method Comparison Study Results IMMAGE® Immunochemistry System Digoxin (DIG) Reagent

Analyte: IMMAGE DIG Reagent
Sample Type: serum
Slope: 1.051
Intercept (ng/mL): 0.13
r: 0.993
n: 113
Predicate Method: Abbott TDx Digoxin II

Estimated IMMAGE System Digoxin (DIG) Reagent Imprecision

Within-Run Imprecision
Sample: Level 1, Mean (ng/mL): 1.04, S.D. (ng/mL): 0.075, %C.V.: 7.2, N: 80
Sample: Level 2, Mean (ng/mL): 2.28, S.D. (ng/mL): 0.060, %C.V.: 2.6, N: 80
Sample: Level 3, Mean (ng/mL): 3.76, S.D. (ng/mL): 0.101, %C.V.: 2.7, N: 80

Total Imprecision
Sample: Level 1, Mean (ng/mL): 1.04, S.D. (ng/mL): 0.077, %C.V.: 7.4, N: 80
Sample: Level 2, Mean (ng/mL): 2.28, S.D. (ng/mL): 0.064, %C.V.: 2.8, N: 80
Sample: Level 3, Mean (ng/mL): 3.76, S.D. (ng/mL): 0.113, %C.V.: 3.0, N: 80

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.

K954627

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

§ 862.3320 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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Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black circle with a white wave-like design inside, followed by the company name in bold, black font. The word "BECKMAN" is stacked on top of "COULTER".

5 1998 NOV

Summary of Safety & Effectiveness Beckman Coulter IMMAGE® Immunochemistry System Digoxin (DIG) Reagent

1.0 Submitted By:

Richard T. Ross Staff Requlatory Specialist. Product Submissions Beckman Coulter, Inc. 200 South Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-4912 FAX: (714) 961-4123

2.0 Date Submitted:

09 September 1998

3.0 Device Name(s):

3.1 Proprietary Names

IMMAGE® Immunochemistry System Digoxin (DIG) Reagent

3.2 Classification Name

Digoxin Test System (21 CFR §862.3320)

4.0 Predicate Device(s):

| NAME OF HONDANIE EN END STATE OF STATE FOR FOR FOR FOR FOR FOR FOR FOR FOR AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND
| 16 INCREASE A MARCHITE WORKER BOOK ON LIE LIE WAS |
BAND DOG RECORD FOR COLLECTION CONSTITUTION OF | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASSURES OF PARK IS E SER OIL OF C E SE E SAN ASSOCIATED STATUS CHOOL S WALLERS | | Abbott™ Laboratones, Inc | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| ------------------ | Company of Children Company of Children Company of | SECTION BO MIT 13 THE CONTROLLERS CONTROL CONSULTION CONSULTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

*Trademark of Abbott Laboratories ** Abbott Laboratories, Abbott Park, IL 60064

5.0 Description:

The IMMAGE® Immunochemistry System Digoxin (DIG) Reagent is designed for optimal performance on the IMMAGE® Immunochemistry Systems. It is intended for the quantitative determination of Digoxin in serum and plasma.

l of 3

. ... --Telephone: (714) 993-5321 Facsimile: (714) 961-4165 Internet: www.beckmancoulter.com

1

6.0 Intended Use:

The IMMAGE® Immunochemistry System Digoxin (DIG) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and IMMAGE® Immunochemistry Systems Drug Calibrator 2, is intended for the quantitative determination of digoxin in human serum or plasma by turbidimetric immunoassay.

The IMMAGE® Immunochemistry Systems Drug Calibrator 2, used in conjunction with IMMAGE® Digoxin reagent, is intended for use on Beckman Coulter's IMMAGE® Immunochemistry Systems for the calibration of digoxin test systems.

7.0 Comparison to Predicate(s):

The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary.

ReagentAspect/CharacteristicComments
IMMAGE System
DIG ReagentIntended use.Same as Abbott TDx
Digoxin II Reagent.
Reaction temperature of 37° C.
Sample types of plasma or serum.

SIMILARITIES to the PREDICATE

DIFFERENCES from the PREDICATE

ReagentAspect/CharacteristicComments
IMMAGE
System DIG
ReagentIMMAGE DIG uses Near Infrared
Particle Immunoassay (NIPIA) rate
immunoassay methodology.Abbott TDx reagents utilize
fluorescence polarization
immunoassay.
Antibody source for IMMAGE DIG is
mouse monoclonal.Antiserum source for TDx
Digoxin II is rabbit.
IMMAGE System DIG uses a single
point calibration.TDx System Digoxin II
calibration is multipoint.
IMMAGE
System DIG
SampleIMMAGE System DIG requires a
sample volume of 12 µL.TDx Digoxin II requires a
sample volume of 160µL.
IMMAGE DIG does not require
sample pretreatment.TDx Digoxin II 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.

Beckman Coulter, Inc. 510(k) Notification IMMAGE® Digoxin Reagent Filename: digSSE.doc

2

Method Comparison Study Results IMMAGE® Immunochemistry System Digoxin (DIG) Reagent

AnalyteSample TypeSlopeIntercept (ng/mL)rnPredicate Method
IMMAGE
DIG Reagentserum1.0510.130.993113Abbott TDx
Digoxin II

Estimated IMMAGE System Digoxin (DIG) Reagent Imprecision

SampleMean (ng/mL)S.D. (ng/mL)%C.V.N
Within-Run Imprecision
Level 11.040.0757.280
Level 22.280.0602.680
Level 33.760.1012.780
Total Imprecision
Level 11.040.0777.480
Level 22.280.0642.880
Level 33.760.1133.080

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.

Beckman Coulter, Inc. 510(k) Notification IMMAGE® Digoxin Reagent Filename: digSSE.doc

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 5 1998

Richard T. Ross Staff Regulatory Specialist Beckman Coulter, Inc. 200 South Kraemer Blvd., W-104 Brea, CA 92822-8000

Re: K983151

Trade Name: Immage Immunochemistry System Digoxin (DIG) Reagent Regulatory Class: II Product Code: KXT Dated: September 9, 1998 Received: September 9, 1998

Dear Mr. Ross:

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 legally marketed predicate 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 Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Steven Sutman

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): Not yet assigned

IMMAGE® Immunochemistry System Device Name: Digoxin (DIG) Reagent

Indications for Use:

The IMMAGE® Immunochemistry System Digoxin (DIG) Reagent, when used in conjunction with Beckman IMMAGE® Immunochemistry Systems and Beckman Drug Calibrator 2, is intended for the quantitative determination of digoxin in human serum or plasma by turbidimetric immunoassay.

Clinical Significance:

Digoxin is administered for conditions of heart failure or in the treatment of certain cardiac arrhythmias. Digoxin therapy is monitored for possible toxicity and inadequate therapuetic response.

Digoxin (21 CFR §862.3320) (b) Classification. Class II.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-the-Counter Use Prescription Use (per 21 CFR 801.109) Optional Format 1-2-96

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983/151