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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Beckman Coulter IMMAGE® Immunochemistry System Digoxin (DIG) Reagent, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" as a set of predefined thresholds that the device had to meet to be approved. Instead, it presents "performance data" which demonstrates substantial equivalence to a predicate device. For the purpose of this request, I will infer the "acceptance criteria" from typical requirements for such devices, focusing on linearity/correlation and precision, and then list the reported performance.

Performance Metric	Inferred Acceptance Criteria (Typical for such devices)	Reported Device Performance (IMMAGE® DIG Reagent)
Method Comparison (Correlation with Predicate)
Slope	Close to 1.0 (e.g., 0.95 - 1.05)	1.051
Intercept (ng/mL)	Close to 0.0 (e.g., ± 0.15)	0.13 ng/mL
Correlation Coefficient (r)	≥ 0.97 (indicating strong linear correlation)	0.993
Imprecision (CV%)
Within-Run Imprecision (Level 1)	≤ 10%	7.2 %C.V.
Within-Run Imprecision (Level 2)	≤ 5%	2.6 %C.V.
Within-Run Imprecision (Level 3)	≤ 5%	2.7 %C.V.
Total Imprecision (Level 1)	≤ 10%	7.4 %C.V.
Total Imprecision (Level 2)	≤ 5%	2.8 %C.V.
Total Imprecision (Level 3)	≤ 5%	3.0 %C.V.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size:
- Method Comparison: 113 samples (presumably human serum)
- Imprecision: 80 measurements per level (3 levels tested, so 240 measurements in total).
Data Provenance: Not explicitly stated (e.g., country of origin). However, given it's a 510(k) submission to the US FDA, it likely involves data from studies conducted in the US or regions adhering to similar regulatory standards. The samples are referred to as "serum," implying human biological samples.
Retrospective or Prospective: Not explicitly stated, but method comparison and imprecision studies are typically conducted prospectively with available samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of in-vitro diagnostic (IVD) device does not typically rely on "experts" to establish a ground truth in the way medical imaging or clinical diagnostic devices might. Instead, the "ground truth" for method comparison is the measurement obtained from the predicate device, and for imprecision, it's the statistical analysis of repeated measurements of known control samples.

Therefore, this section is not applicable in the traditional sense for this type of device and study. The predicate device (Abbott TDx Digoxin II) serves as the "reference method" for comparison.

4. Adjudication Method for the Test Set

This is not applicable for this type of IVD device and study. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in subjective diagnostic tasks where multiple human readers interpret data (e.g., radiology, pathology). Here, results are quantitative measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This device is an in-vitro diagnostic (IVD) immunoassay system that provides quantitative measurements of digoxin in serum/plasma. It is not an AI-powered diagnostic tool for human readers, nor does it have a human-in-the-loop component for interpretation that would warrant an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The performance data presented ("Method Comparison Study Results" and "Estimated IMMAGE System Digoxin (DIG) Reagent Imprecision") represents the standalone performance of the IMMAGE® Immunochemistry System Digoxin (DIG) Reagent itself. It measures the device's ability to quantitatively determine digoxin levels without any human interpretive intervention.

7. The Type of Ground Truth Used

For Method Comparison: The "ground truth" was established by the predicate device, the Abbott TDx Digoxin II. The IMMAGE® DIG Reagent's measurements were compared against the measurements obtained from this established, legally marketed device.
For Imprecision: The "ground truth" was derived from control samples with known or well-characterized digoxin concentrations. The imprecision study assesses the device's reproducibility and precision when repeatedly measuring these controls.

8. The Sample Size for the Training Set

The document does not provide any information about a "training set" sample size. For an immunoassay reagent, the development process (which might involve optimization or "training" of assay parameters) is typically based on laboratory experiments and analytical validation rather than a distinct "training set" of patient samples in the way machine learning algorithms are trained. The data presented here is for analytical performance validation.

9. How the Ground Truth for the Training Set was Established

As no "training set" is described for this type of device, this point is not applicable. The ground truth for the analytical validation (test set) was established by comparison with a predicate device and characterized control samples, as described in point 7.

Summary

{0}------------------------------------------------

983/51

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:

l of 3

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

{1}------------------------------------------------

6.0 Intended Use:

7.0 Comparison to Predicate(s):

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

Reagent	Aspect/Characteristic	Comments
IMMAGE SystemDIG Reagent	Intended use.	Same as Abbott TDxDigoxin II Reagent.
	Reaction temperature of 37° C.
	Sample types of plasma or serum.

SIMILARITIES to the PREDICATE

DIFFERENCES from the PREDICATE

Reagent	Aspect/Characteristic	Comments
IMMAGESystem DIGReagent	IMMAGE DIG uses Near InfraredParticle Immunoassay (NIPIA) rateimmunoassay methodology.	Abbott TDx reagents utilizefluorescence polarizationimmunoassay.
	Antibody source for IMMAGE DIG ismouse monoclonal.	Antiserum source for TDxDigoxin II is rabbit.
	IMMAGE System DIG uses a singlepoint calibration.	TDx System Digoxin IIcalibration is multipoint.
IMMAGESystem DIGSample	IMMAGE System DIG requires asample volume of 12 µL.	TDx Digoxin II requires asample volume of 160µL.
	IMMAGE DIG does not requiresample pretreatment.	TDx Digoxin II requiressample 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

Analyte	Sample Type	Slope	Intercept (ng/mL)	r	n	Predicate Method
IMMAGEDIG Reagent	serum	1.051	0.13	0.993	113	Abbott TDxDigoxin II

Estimated IMMAGE System Digoxin (DIG) Reagent Imprecision

Sample	Mean (ng/mL)	S.D. (ng/mL)	%C.V.	N
Within-Run Imprecision
Level 1	1.04	0.075	7.2	80
Level 2	2.28	0.060	2.6	80
Level 3	3.76	0.101	2.7	80
Total Imprecision
Level 1	1.04	0.077	7.4	80
Level 2	2.28	0.064	2.8	80
Level 3	3.76	0.113	3.0	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.

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

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines that converge to form the head and body of the bird.

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.

{4}------------------------------------------------

Page 2

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
ว

Regulation Number and Section

§ 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.