K Number

Device Name

QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM

Manufacturer

SERADYN

Date Cleared

2002-10-24

(41 days)

Product Code

KXT

Regulation Number

862.3320

Intended Use

The SERADYN OMS™ DIGOXIN assay is used for the quantitation of digoxin in human serum or plasma on the Abbott AEROSET® System. Digoxin is a potent cardiac glycoside widely prescribed for the treatment of patients suffering from congestive heart failure, as well as some types of cardiac arrhythmias. Digoxin intoxication is a common and serious problem in the clinical setting. This is, in part, a result of the fact that cardiac glycosides have a low therapeutic ratio (a very small difference between therapeutic and tissue toxic levels). Coupled with the narrow therapeutic range is a marked patient variability in response to the same dosage of drug, often resulting in unpredictable serum drug levels. Intoxication symptoms are often indistinguishable from the original condition for which the drug was prescribed. It may not be immediately apparent whether the patient has been under or overdosed. Monitoring serum digoxin levels combined with other clinical data can provide the physician with useful information to aid in adjusting patient dosage and achieving optimal therapeutic effect while avoiding useless sub-therapeutic or harmful toxic dosage levels.

Device Description

The Seradyn QMS™ Digoxin Assay is a homogeneous Particle Enhanced Turbidimetric Immunoassay used for the quantitation of digoxin in serum or plasma. The assay is intended for use on the Abbott AEROSET® System, using the Seradyn QMS Digoxin Calibrators (previously cleared as Digoxin Immunoassay K983323. The reagent system components are 1) digoxin coated microparticle reagent, and 2) the antibody reagent which consists of a mouse monoclonal antibody specific for digoxin. The technology is based on competition between the digoxin in the sample and digoxin coated onto the microparticles, for the antibody-binding sites of the anti-digoxin antibody reagent. In the absence of digoxin in the sample, the specific antibody in the antibody reagent binds the digoxin on the particle, and results in rapid agglutination of the microparticles. In the presence of digoxin in the sample, the digoxin in the sample competes for antibody binding sites of the specific antibody in the antibody reagent, and partially inhibits the agglutination of the microparticles. The rate of agglutination (turbidity) is directly proportional to the rate in absorbance change of incident light and is measured spectrophotometrically by the Abbott AEROSET® System at a wavelength of 700 nm. A six level Seradyn QMS™ Digoxin Calibrator set, with known digoxin concentrations is used to quantitate the assay. An internal concentration-dependent calibration curve is generated by the AEROSET® System, by measuring the rate of absorbance change of each calibrator level. Maximum absorbance rate is at the lowest digoxin concentration and the lowest absorbance rate at the highest digoxin concentration. By monitoring the change in rate of a specimen with unknown digoxin concentration, and comparing to the internal calibration curve, a sample's concentration can readily be obtained and reported as digoxin concentration in either ng/ml or nmol/L.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K953239

Reference Devices

K983323

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard turbidimetric immunoassay and spectrophotometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation. The analysis relies on a pre-defined calibration curve.

Therapeutic

No.
This device is an in-vitro diagnostic assay used for the quantitative measurement of digoxin in human serum or plasma to aid in monitoring patient dosage and achieving optimal therapeutic effect, not directly for treatment.

Diagnostic

Yes

The device quantifies digoxin levels in human serum or plasma to aid in adjusting patient dosage and achieving optimal therapeutic effect while avoiding harmful toxic dosage levels. This information helps physicians diagnose and manage conditions related to digoxin toxicity or ineffective therapy.

SaMD (Software as a Medical Device)

The device is a laboratory assay kit consisting of reagents (microparticles and antibody) used on a specific hardware system (Abbott AEROSET® System) to measure digoxin levels. It is not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that the assay is "used for the quantitation of digoxin in human serum or plasma". This involves testing a biological sample (serum or plasma) in vitro (outside the body) to obtain information about a patient's health status (digoxin levels).
Device Description: The description details a laboratory assay that uses reagents and a spectrophotometer to measure a substance in a biological sample. This is characteristic of an in vitro diagnostic device.
Performance Studies: The performance studies describe testing the device's ability to accurately and reliably measure digoxin in human serum and plasma samples. This type of testing is required for IVD devices to demonstrate their analytical and clinical performance.
Predicate Device: The mention of a predicate device (Roche Tina-quant Digoxin) which is also an immunoassay for digoxin in serum/plasma, further indicates that this device falls within the category of IVDs.

Therefore, based on the provided information, the SERADYN OMS™ DIGOXIN assay is an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SERADYN OMS™ DIGOXIN assay is used for the quantitation of digoxin in human serum or plasma on the Abbott AEROSET® System.

Digoxin is a potent cardiac glycoside widely prescribed for the treatment of patients suffering from congestive heart failure, as well as some types of cardiac arrhythmias. Digoxin intoxication is a common and serious problem in the clinical setting. This is, in part, a result of the fact that cardiac glycosides have a low therapeutic ratio (a very small difference between therapeutic and tissue toxic levels). Coupled with the narrow therapeutic range is a marked patient variability in response to the same dosage of drug, often resulting in unpredictable serum drug levels. Intoxication symptoms are often indistinguishable from the original condition for which the drug was prescribed. It may not be immediately apparent whether the patient has been under or overdosed.

Monitoring serum digoxin levels combined with other clinical data can provide the physician with useful information to aid in adjusting patient dosage and achieving optimal therapeutic effect while avoiding useless sub-therapeutic or harmful toxic dosage levels.

Product codes

KXT, DLJ

Device Description

The reagent system components are 1) digoxin coated microparticle reagent, and 2) the antibody reagent which consists of a mouse monoclonal antibody specific for digoxin.

The technology is based on competition between the digoxin in the sample and digoxin coated onto the microparticles, for the antibody-binding sites of the anti-digoxin antibody reagent. In the absence of digoxin in the sample, the specific antibody in the antibody reagent binds the digoxin on the particle, and results in rapid agglutination of the microparticles. In the presence of digoxin in the sample, the digoxin in the sample competes for antibody binding sites of the specific antibody in the antibody reagent, and partially inhibits the agglutination of the microparticles. The rate of agglutination (turbidity) is directly proportional to the rate in absorbance change of incident light and is measured spectrophotometrically by the Abbott AEROSET® System at a wavelength of 700 nm.

A six level Seradyn QMS™ Digoxin Calibrator set, with known digoxin concentrations is used to quantitate the assay. An internal concentration-dependent calibration curve is generated by the AEROSET® System, by measuring the rate of absorbance change of each calibrator level. Maximum absorbance rate is at the lowest digoxin concentration and the lowest absorbance rate at the highest digoxin concentration.

By monitoring the change in rate of a specimen with unknown digoxin concentration, and comparing to the internal calibration curve, a sample's concentration can readily be obtained and reported as digoxin concentration in either ng/ml or nmol/L.

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

The results of the clinical testing (Performance Characteristics) of the Seradyn OMS Digoxin assay were compared to results of the studies reported in the Roche Tina-quant Digoxin Package Insert.

A. Specificity
Cross-reactivity was tested on the AEROSET using the Seradyn QMS Digoxin assay. The major digoxin active metabolites, digoxigenin bis-digitoxoside, digoxigenin monodigitoxoside, and digoxigenin, as well as digitoxin, another cardiac glycoside, and its common analogue, digitoxigenin, were tested.
The % cross reactivity on the AEROSET was compared to the reported Roche Tina-quant cross reactivity.
Cross-reactivity for Digitoxigenin: AEROSET 0.5%, Tina-quant

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.

Summary

OCT 2 4 2002

510K SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K023058

1. Company/contact person:

Seradyn, Inc 7998 Georgetown Road. Suite 1000 Indianapolis, IN 46268

Establishment registration No: 1836010

Lisa Brown Director of Quality Telephone: (317) 610-3821 Fax: (317) 610-0018 e-mail: lbrown@seradyn.com

1. Prepared:
  September 12, 2002

3. Device Name:

a. Proprietary Name:	QMS™ Digoxin on the Abbott AEROSET® System
b. Common Name:	Digoxin Particle Enhanced Immunoturbimetric Assay
c. Classification Name:	862.3320 Enzyme Immunoassay, Digoxin

4. Legally marketed devices to which equivalency is claimed:

Seradyn QMS™ Digoxin on the Abbott AEROSET® System is substantially equivalent to the Roche Tina-quant Digoxin cleared under K953239.

5. Description of Device:

The reagent system components are 1) digoxin coated microparticle reagent, and 2) the antibody reagent which consists of a mouse monoclonal antibody specific for digoxin.

6. Intended Use:

The SERADYN OMS™ DIGOXIN assay is used for the quantitation of digoxin in human serum or plasma.

	Device Name
	QMS™ Digoxin	Tina-quant® Digoxin
Indications
for Use	The Seradyn QMS™ Digoxin assay is used
for the quantitation of digoxin in human
serum or plasma on the Abbott AEROSET®
System.
Digoxin is a potent cardiac glycoside widely
prescribed for the treatment of patients
suffering from congestive heart failure, as
well as some types of cardiac arrhythmias.
Digoxin intoxication is a common and serious
problem in the clinical setting.
Monitoring serum digoxin levels combined
with other clinical data can provide the
physician with useful information to aid in
adjusting patient dosage, achieving optimal
therapeutic effect while avoiding useless
subtherapeutic or harmful toxic dosage levels.	The Tina-quant Digoxin method is used for
the quantitative determination of digoxin, a
cardioactive drug, in human serum and
plasma on the Hitachi® analyzers.
Measurements are used in the diagnosis and
treatment of digoxin overdose and in
monitoring levels of digoxin to ensure proper
therapy.
	Device Name
	QMS™ Digoxin	Tina-quant® Digoxin
Reagent
Components	Two (2) reagent system
Anti-digoxin Antibody reagent (R1)Digoxin coated Microparticle reagent
(R2)	Two (2) reagent system
Anti-digoxin Antibody reagent (R1)Digoxin coated Microparticle reagent
(R2)
Calibration	Seradyn QMS™ Digoxin Calibrators - Six
levels	Preciset Digoxin Calibrators - Six levels
Assay Range	0.05 to 5.0 ng/mL
(0.06 to 6.40 nmol/L)	0.15 to 7.5 ng/mL
(0.19 to 9.6 nmol/L)
Method
Principles	The Seradyn QMS™ Digoxin Assay is a
homogeneous Particle Enhanced
Turbidimetric Immunoassay based on the
principle of spectrophotometrically
measuring turbidity and changes in absorbed
light, which result when activated
microspheres agglutinate.

The microspheres (R2) are coated with
digoxin, which in the presence of an anti-
digoxin antibody (R1), rapidly agglutinate.
The sample is incubated with the Antibody
reagent. The microparticles are added and
allowed to incubate. In the absence of any
digoxin in the sample, rapid agglutination
occurs, resulting in a turbid solution. When a
sample containing digoxin is introduced, the
agglutination is partially inhibited, slowing
down the agglutination process. Thus the
Abbott AEROSET® analyzer can measure
the resulting turbidity and generate a classic
inhibition curve (calibration curve), with
respect to concentration, with maximum rate
of agglutination at the lowest digoxin
concentration, and minimum rate of
agglutination at the highest digoxin
concentration. By monitoring the change in
rate of specimen agglutination (absorbance
rate), and comparing to the internal
calibration curve, a sample's concentration
can readily be obtained and reported as
digoxin concentration in either ng/ml or
nmol/L. | The Tina-quant® Digoxin is also a
homogeneous Particle Enhanced
Turbidimetric Immunoassay with exactly the
same principles as the Seradyn QMS™
Digoxin Assay. The only difference is that
the turbidity (change in absorbance) is
measured spectrophotometrically on the
Hitachi® analyzers. The digoxin
concentration can also be reported in ng/ml
or nmol/L. |

7. Comparison of Technological Characteristics:

Tina-quant® and Hitach® are registered trademarks of Roche Diagnostics Corp.

8. Summary of Non-clinical Testing:

NONE

9. Summary of Clinical Testing:

The results of the clinical testing (Performance Characteristics) oof the Seradyn OMS Digoxin assay were compared to results of the studies reported in the Roche Tina-quant Digoxin Package Insert.

A. Specificity

Cross-reactivity was tested on the AEROSET using the Seradyn QMS Digoxin assay. The major digoxin active metabolites, digoxigenin bis-digitoxoside, digoxigenin monodigitoxoside, and digoxigenin, as well as digitoxin, another cardiac glycoside, and its common analogue, digitoxigenin, were tested.

Cross reactivity was calculated using the following formula:

(Equivalent digoxin conc of spiked sample – Dgoxin conc of sample without cross reactant) X 100% Conc of cross reactant

The % cross reactivity on the AEROSET was compared to the reported Roche Tina-quant cross reactivity.

| | AEROSET
Conc. of | | Tina-quant | |
|-------------------------------|---------------------|------------------------|----------------------------------|------------------------|
| | Cross-Reactant | | Conc. of | |
| | Spiked (ng/mL) | % Cross-
Reactivity | Cross-Reactant
Spiked (ng/mL) | % Cross-
Reactivity |
| Compound | | | | |
| Digitoxigenin | 500 | 0.5% | Not Reported | K023058 Trade/Device Name: Seradyn QMS™ Digoxin on the Abbott Aeroset® System Regulation Number: 21 CFR 862.3320 Regulation Name: Digoxin test system Regulatory Class: Class II Product Code: KXT: DLJ Dated: September 12, 2002 Received: September 13, 2002

Dear Ms. Brown:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Page 2 -

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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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

Rev 1 9/12/02

INDICATIONS FOR USE FORM K023058

510(k) Number (if known): -

SERADYN QMS™ DIGOXIN ON THE ABBOTT AEROSET® SYSTEM Device Name:

Indications For Use:

The SERADYN OMS™ DIGOXIN assay is used for the quantitation of digoxin in human serum or plasma on the Abbott AEROSET® System.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

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(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number _