QUALISYS PSA IMMUNOASSAY

• K Number: K990234
• Device Name: QUALISYS PSA IMMUNOASSAY
• Manufacturer: QUALISYS DIAGNOSTICS, INC.
• Date Cleared: 1999-07-08 ( 164 days)
• Product Code: LTJ
• Regulation Number: 866.6010

Intended Use

The Qualisys PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum. The Qualisys PSA Immunoassay is further indicated for the serial measurement of PSA as an aid in the prognosis and management of patients with prostate cancer.

Device Description

The Qualisys PSA Immunoassay is a two-site chemiluminescense assay. 1st incubation: 15 minutes at room temperature. Specimen, control or calibrator [100 µL] and PSA Antibody Solution [100 µL] react to form a sandwich complex. 2nd incubation: 2 minutes at room temperature. Streptavidin-coated paramagnetic particle solution [25 µL] is added to the reaction mixture. After the 2-minute incubation, the sandwich complex is bound to the solid-phase via the interaction of biotin and streptavidin. Removal of unbound materials: The paramagnetic particles are washed four times with wash buffer [1.0 mL/wash] to remove unbound materials. Re-suspension of paramagnetic particles: Deionized (DI) water [25 uL] is added to re-suspend the washed paramagnetic particles. Substrate addition and detection: Chemiluminogenic substrate [50 uL] is added to the solid-phase bound complex and results in "glow" chemiluminescence, which is measured using a luminometer (photomultiplier). Emission of light is quantified for 1 second, and is expressed in relative light units (RLU). The amount of bound labeled antibody in RLU's is directly proportional to the concentration of PSA in the sample. Results are determined using cubic spline immunoassay curve fitting.

Predicate Devices

P910007

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard immunoassay process and data analysis using cubic spline curve fitting, with no mention of AI or ML.

Therapeutic

No

This device is an in vitro diagnostic immunoassay for quantitative determination of PSA levels, used as an aid in prognosis and management of prostate cancer. It does not directly treat or alleviate a medical condition, which is the definition of a therapeutic device.

Diagnostic

Yes
The device is intended for the quantitative determination of prostate-specific antigen (PSA) in human serum, specified as an "aid in the prognosis and management of patients with prostate cancer," which directly supports disease diagnosis and management.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a multi-step chemical assay process involving reagents, incubations, washes, and measurement using a luminometer. This involves physical components and chemical reactions, not solely software.

IVD (In Vitro Diagnostic)

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

The "Intended Use / Indications for Use" section explicitly states: "The Qualisys PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum."

The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of a living organism. The determination of PSA in human serum (a biological sample) using laboratory methods clearly falls under the definition of an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Qualisys PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum. The Qualisys PSA Immunoassay is further indicated for the serial measurement of PSA as an aid in the prognosis and management of patients with prostate cancer.

Product codes

LTJ

Device Description

The Qualisys PSA Immunoassay is a two-site chemiluminescense assay. 1st incubation: 15 minutes at room temperature. Specimen, control or calibrator [100 μL] and PSA Antibody Solution [100 μL] react to form a sandwich complex. 2nd incubation: 2 minutes at room temperature. Streptavidin-coated paramagnetic particle solution [25 μL] is added to the reaction mixture. After the 2-minute incubation, the sandwich complex is bound to the solid-phase via the interaction of biotin and streptavidin. Removal of unbound materials: The paramagnetic particles are washed four times with wash buffer [1.0 mL/wash] to remove unbound materials.
Re-suspension of paramagnetic particles: Deionized (DI) water [25 uL] is added to re-suspend the washed paramagnetic particles.
Substrate addition and detection: Chemiluminogenic substrate [50 uL] is added to the solid-phase bound complex and results in "glow" chemiluminescence, which is measured using a luminometer (photomultiplier). Emission of light is quantified for 1 second, and is expressed in relative light units (RLU).
The amount of bound labeled antibody in RLU's is directly proportional to the concentration of PSA in the sample. Results are determined using cubic spline immunoassay curve fitting.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Prostate

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

Method Comparison: versus Abbott IMx® PSA: n = 108; Range of values (Abbott): 0 to 46.83 ng PSA/mL; Range of values (Qualisys): 0 to 42.30 ng PSA/mL; y = 0.9955x + 0.5185 (Least Squares); r^2 = 0.9747; S^2_slope = 0.000243; S^2_y-intercept = 0.067012

Key Metrics

Precision Intra-assay: Low (0.52) 3.4%; Med (3.05) 1.7%; High (23.06) 3.0%
Inter-assay: Low (0.52) 5.7%; Med (3.05) 2.6%; High (23.06) 3.7%
Analytical Sensitivity: 0.003 ng PSA/mL
Functional Sensitivity: 0.1 ng PSA/mL
Spike Recovery: 90 to 110%
Dilution Recovery: 92 to 108%
Interfering Substances: No interference up to: Bilirubin 49 mg/dL; Hemoglobin 600 mg/dL; IgG 1900 mg/dL; PAP 1000 ng/mL; Protein 13 g/dL; Triglycerides 2730 mg/dL; Cyclophosphamide 700 μg/mL; DES 2 μg/mL; Doxorubicin HCI 16 μg/mL; Methotrexate 30 μg/mL; Megestrol Acetate 90 μg/mL; Flutamide 10 μg/mL; Lupron 100μg/mL
High Dose Hook Effect: No high dose hook effect up to 1250 ng/mL

Predicate Device(s)

P910007

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 866.6010 Tumor-associated antigen immunological test system.

(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

Summary

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Image /page/0/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '990234'. The characters are written in a simple, slightly irregular style.

Image /page/0/Picture/2 description: The image shows the logo for Qualisys Diagnostics, Inc. The word "Qualisys" is in a large, bold font, with the "Q" being particularly large and stylized. Below "Qualisys" is the text "Diagnostics, Inc." in a smaller font. The logo is simple and professional.

510(k) Summary

Qualisys PSA Immunoassay

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

| 1. | Submitter
name, address,
contact | Qualisys Diagnostics, Incorporated
16 Technology Drive, Suite 118
Irvine, CA 92618 |
|----|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Telephone: [phone]
Fax: [phone] |
| | | Contact Person: Grace Kwan |
| | | Date Prepared: May 19, 1999 |
| 2. | Device name | Proprietary name: Qualisys PSA Immunoassay |
| | | Common name: Chemiluminescense assay for the determination of
Prostate-Specific Antigen (PSA). |
| | | Classification Name: Prostate-Specific Antigen (PSA) for Management
of Prostate Cancers |
| 3. | Predicate
device | Abbott IMx® PSA
(P910007) |
| 4. | Device
description | The Qualisys PSA Immunoassay is a two-site chemiluminescense assay. 1st incubation: 15 minutes at room temperature. Specimen, control or calibrator [100 µL] and PSA Antibody Solution [100 µL] react to form a sandwich complex. 2nd incubation: 2 minutes at room temperature. Streptavidin-coated paramagnetic particle solution [25 µL] is added to the reaction mixture. After the 2-minute incubation, the sandwich complex is bound to the solid-phase via the interaction of biotin and streptavidin. Removal of unbound materials: The paramagnetic particles are washed four times with wash buffer [1.0 mL/wash] to remove unbound materials. |
| | | 16 Technology Drive, Suite 118 • Irvine, CA 92618
[phone] • Fax [phone]
Attachment 1
Page 1 of 4 |

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Qualisys Diagnostics, Incorporated

| | Device
description
(continued) | Re-suspension of paramagnetic particles: Deionized (DI) water [25
uL] is added to re-suspend the washed paramagnetic particles. | | | |
|----|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | | | Substrate addition and detection: Chemiluminogenic substrate [50 uL]
is added to the solid-phase bound complex and results in "glow"
chemiluminescence, which is measured using a luminometer
(photomultiplier). Emission of light is quantified for 1 second, and is
expressed in relative light units (RLU). | | |
| | | The amount of bound labeled antibody in RLU's is directly
proportional to the concentration of PSA in the sample. Results are
determined using cubic spline immunoassay curve fitting. | | | |
| 5. | Intended use | The Qualisys PSA Immunoassay is a paramagnetic particle immunoassay
intended for the in vitro quantitative determination of prostate-specific
antigen (PSA) in human serum. The Qualisys PSA Immunoassay is
further indicated for the serial measurement of PSA as an aid in the
prognosis and management of patients with prostate cancer. | | | |
| 6. | Comparison to
predicate
device | The Qualisys PSA Immunoassay is substantially equivalent to other
products in commercial distribution intended for similar use. Most notably
it is substantially equivalent to the currently marketed Abbott IMx® PSA.
The following tables compare the Qualisys PSA Immunoassay with the
predicate device, Abbott IMx® PSA: | | | |
| | | | | | |
| | | Similarities: | | | |
| | | Assay Methodology:
● | Sandwich immunoassay | | |
| | | Sample Type: | Serum | | |
| | | Storage Condition: | 2-8 °C | | |
| | | I abel | Alkaline Phosphatase | | |

• Photomultiplier Tube (PMT) Detector: .

2

Qualisys Diagnostics, Incorporated

510(k) Summary (continued)

Comparison to	Differences:
predicate
(continued)	Feature	Qualisys PSA	Abbott IMx® PSA
	Intended Use	For the in vitro
quantitative determination
of PSA in human serum.
It is further indicated for
the serial measurement of
PSA as an aid in the
prognosis and
management of patients
with prostate cancer.	For the quantitative
measurement of PSA in
human serum: 1) as an
aid in the detection of
prostate cancer when
used in conjunction with
DRE in men aged 50
years or older. Prostatic
biopsy is required for
diagnosis of cancer; 2) as
an adjunctive test used as
an aid in the management
of prostate cancer
patients.
	Sample Volume	100 µL	150 µL
	Assay Range	0 to 50 ng/mL	0 to 100 ng/mL
	Temp. Control	Not Required
(Room Temperature)	Required
	Instrument
Required	Zylux Luminometer	Abbott IMx® Analyzer
	Test Processing	Manual
(A liquid handling system
may be use to assist in the
pipetting of multiple
samples.)	Automated
	Control Levels	2	3
	Calibration
Levels	5	6
	Capture
Antibody	Monoclonal	Polyclonal
	Solid-phase	Streptavidin-coated
paramagnetic particles	Monoclonal Anti-PSA
coated microparticles
	Substrate	ImmuGlow™ (Indoxyl -3-
phosphate and lucigenin)	4-Methylumbelliferyl
Phosphate
	Detection	Chemiluminescence	Fluorescence
	Data Analysis	External software: cubic
spline for curve fitting and
data reduction	Internal data reduction
via microcomputer
	Calibration	Full calibration curve with
every run	Full calibration curve
every 4 weeks
Comparison to
predicate
device
(continued)	Performance Characteristics:
Feature	Qualisys PSA
ng/mL PSA	Abbott IMx® PSA
ng/mL PSA
	Precision
Intra-assay	Low (0.52) 3.4%
Med (3.05) 1.7%
High (23.06) 3.0%	Low (4.6) 3.5%
Med (15.6) 3.3%
High (60.2) 3.1%
	Inter-assay	Low (0.52) 5.7%
Med (3.05) 2.6%
High (23.06) 3.7%	Low (4.6) 4.7%
Med (15.6) 4.5%
High (60.2) 5.3%
	Analytical
Sensitivity	0.003 ng PSA/mL	0.1 ng PSA/mL
	Functional
Sensitivity	0.1 ng PSA/mL	Not reported
	Spike Recovery	90 to 110%	91 to 103%
	Dilution
Recovery	92 to 108%	Not reported
	Method
Comparison	versus Abbott IMx® PSA:
n = 108
Range of values (Abbott): 0 to 46.83 ng PSA/mL
Range of values (Qualisys): 0 to 42.30 ng PSA/mL
$y = 0.9955x + 0.5185 (Least Squares)$
$r^2$ = 0.9747
$S^2_{slope}$ = 0.000243
$S^2_{y-intercept}$ = 0.067012
	Interfering
Substances	No interference up to:
Bilirubin 49 mg/dL
Hemoglobin 600 mg/dL
IgG 1900 mg/dL
PAP 1000 ng/mL
Protein 13 g/dL
Triglycerides 2730 mg/dL
Cyclophosphamide 700 µg/mL
DES 2 µg/mL
Doxorubicin HCI 16 µg/mL
Methotrexate 30 µg/mL
Megestrol Acetate 90 µg/mL
Flutamide 10 µg/mL
Lupron 100µg/mL	No interference up to:
25 mg/dL
600 mg/dL
250-2900 mg/dL
1000 ng/mL
3-13 g/dL
3000 mg/dL
700 µg/mL
2 µg/mL
16 µg/mL
30 µg/mL
90 µg/mL
10 µg/mL
100µg/mL
	High Dose Hook
Effect	No high dose hook effect
up to 1250 ng/mL	Not reported

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL - 9 1999

Ms. Grace Kwan Director, Ouality and Regulatory Affairs Qualisys Diagnostics, Inc. 16 Technology Drive, Suite 118 Irvine, California 92618

Re: K990234

Trade Name: Oualisys PSA Immunoassay Regulatory Class: II Product Code: LTJ Dated: May 19, 1999 Received: May 20, 1999

Dear Ms. Kwan:

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 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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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrlv/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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

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Attachment 4

.

ﻤﺴﻴﺴﻴﺔ

)

Indications for Use Statement

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510(k) Number	K990234
Device Name	Qualisys PSA Immunoassay
Indications for Use	The Qualisys PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum. The Qualisys PSA Immunoassay is further indicated for the serial measurement of PSA as an aid in the prognosis and management of patients with prostate cancer.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IS NEEDED ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K990234

| Prescription Use

(Per 21 CFR 801.109)	✓	OR	Over-The-Counter Use
------------------------------------------	--------------	----	----------------------	--