(86 days)
Hybritech Tandem®-R PSA
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No
The description details a standard chemiluminescence immunoassay with results determined via a calibration curve, not through AI/ML algorithms. There is no mention of AI, ML, or related concepts.
No
The device is an in vitro diagnostic (IVD) assay designed to measure PSA levels, providing data for diagnostic purposes rather than directly treating a condition.
Yes
The device quantitatively determines prostate specific antigen (PSA) in human serum, which is used as an adjunct in the management of patients with prostate cancer. This clearly indicates its role in aiding in the diagnosis or management of a disease state.
No
The device description clearly outlines a chemical assay process involving reagents, incubations, magnetic particles, and a luminometer to quantify PSA. This involves significant hardware components and chemical reactions, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of prostate specific antigen (PSA) in human serum." This indicates it's used to analyze a sample taken from the human body (serum) to provide diagnostic information (PSA levels).
- Device Description: The description details a "two-site chemiluminescence assay" that measures the amount of PSA in the sample. This is a laboratory-based test performed in vitro (outside the body).
- Management of Patients: The intended use also states it's to be used as an "adjunct in the management of patients with prostate cancer." This clearly links the test results to clinical decision-making and patient care, which is a key characteristic of IVDs.
- Sample Type: The device uses "human serum," which is a biological sample.
- Measurement: It performs a "quantitative determination" of PSA, providing a numerical result.
All these factors align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
Intended for use with the Nichols Advantage Specialty System for the quantitative determination of prostate specific antigen (PSA) in human serum and is to be used as an adjunct in the management of patients with prostate cancer.
Product codes (comma separated list FDA assigned to the subject device)
LTJ
Device Description
The Nichols Advantage™ PSA is a two-site chemiluminescence assay. Total duration of assay is 30 minutes at 37ºC.
1st Incubation: 20 minutes at 37℃. Sample or control or calibrator (20uL), biotinylated monoclonal PSA specific antibody (80uL), and acridinium labeled rabbit specific antibody (50uL) react to form a sandwich complex.
2nd Incubation: 10 minutes at 37℃. Assay buffer (50uL) and streptavidin coated magnetic particles (25uL) are added to the reaction mixture. After the 10 minute incubation, the sandwich complex is bound to the solid phase via the interaction of biotin and streptavidin.
The reaction mixture is aspirated from the reaction well after the streptavidin magnetic particles are magnetically captured onto the surface of the reaction well wall. The magnetic particles are washed three times with system wash buffer.
Acridinium esters emit light upon treatment with hydrogen peroxide and an alkaline solution. The Trigger 1 solution contains hydrogen peroxide in dilute acid and Trigger 2 solution contains dilute sodium hydroxide. The system automatically injects Trigger 1 and 2 into the reaction well which oxidize the acridinium ester. The oxidized product is in an excited state. The subsequent return to ground state results in the emission of light which is quantified in 2 seconds, and is expressed in relative light units (RLU) by the integrated system luminometer.
The amount of bound labeled antibody in RLU's is directly proportional to the concentration of PSA in the sample. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar codes.
Mentions image processing
Not Found
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)
Precision:
Intra-Assay (Pool 1, N=20): Mean (ng/mL) 0.6, %CV 6.1
Intra-Assay (Pool 2, N=20): Mean (ng/mL) 3.9, %CV 2.3
Intra-Assay (Pool 3, N=20): Mean (ng/mL) 23.6, %CV 2.7
Inter-Assay (Pool 4, N=20): Mean (ng/mL) 0.7, %CV 9.8
Inter-Assay (Pool 5, N=20): Mean (ng/mL) 4.2, %CV 3.6
Inter-Assay (Pool 6, N=20): Mean (ng/mL) 27.7, %CV 9.1
Sensitivity: 0.1 ng/mL
High Dose Hook: no hook effect up to 5,000 ng/mL
Recovery: 93-106%
Parallelism: 89-108%
Interfering Substances:
No interference up to: hemoglobin 800 mg/dL, bilirubin 25 mg/dL, lipemia (triglycerides) 2325 mg/dL, PAP 1,000 ng/mL
Method Comparison: versus Hybritech Tandem-R PSA
n=183 split samples
Range of values 0.1 to 24.6 ng/mL (Hybritech)
Range of values 0.1 to 22.3 ng/mL (Nichols)
y = 0.974x + 0.25 (Deming linear regression)
95% confidence of the slope: 0.906 - 1.042
95% confidence of the intercept: -0.34 to 0.84
R = 0.885
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 0.1 ng/mL
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.
Hybritech Tandem®-R PSA
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
§ 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.
0
510(k) SUMMARY
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
K965031 1780716 510(k) Number:
APR - 3 1998
- Name of Submitter, Contact Person and Date Summary prepared:
Nichols Institute Diagnostics 33051 Calle Aviador San Juan Capistrano, California 92675 Phone: 714-240-5260 Fax: 714-240-5313
Contact Person: Jimmy Wong Date Prepared: January 5, 1998
-
- Device Name:
| Trade/Proprietary Name: | Nichols Advantage™ Chemiluminescence Prostate Specific Antigen Assay |
|---|---|
| Common/Usual Name: | Chemiluminescence assay for the determination of prostate-specific antigen (PSA). |
| Classification Name: | System, Test, Prostate Specific Antigen |
3. Predicate Device:
We claim substantial equivalence to the Hybritech Tandem®-R PSA
4. Device Description:
The Nichols Advantage™ PSA is a two-site chemiluminescence assay. Total duration of assay is 30 minutes at 37ºC.
18 Incubation: 20 minutes at 37℃. Sample or control or calibrator (20uL), biotinylated monoclonal PSA specific antibody (80uL), and acridinium labeled rabbit specific antibody (50uL) react to form a sandwich complex.
2nd Incubation: 10 minutes at 37℃. Assay buffer (50uL) and streptavidin coated magnetic particles (25uL) are added to the reaction mixture. After the 10 minute incubation, the sandwich complex is bound to the solid phase via the interaction of biotin and streptavidin.
The reaction mixture is aspirated from the reaction well after the streptavidin magnetic particles are magnetically captured onto the surface of the reaction well wall. The magnetic particles are washed three times with system wash buffer.
1
Acridinium esters emit light upon treatment with hydrogen peroxide and an alkaline solution. The Trigger 1 solution contains hydrogen peroxide in dilute acid and Trigger 2 solution contains dilute sodium hydroxide. The system automatically injects Trigger 1 and 2 into the reaction well which oxidize the acridinium ester. The oxidized product is in an excited state. The subsequent return to ground state results in the emission of light which is quantified in 2 seconds, and is expressed in relative light units (RLU) by the integrated system luminometer.
The amount of bound labeled antibody in RLU's is directly proportional to the concentration of PSA in the sample. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar codes.
5. Intended Use:
Intended for use with the Nichols Advantage Specialty System for the quantitative determination of prostate specific antigen (PSA) in human serum and is to be used as an adjunct in the management of patients with prostate cancer.
Comparison to predicate device: 6.
The Nichols Advantage PSA is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Hybritech Tandem®-R PSA.
The following tables compare the Nichols Advantage™ PSA with the predicate device, Hybritech Tandem®-R PSA.
Similarities:
- . Intended Use: For the quantitative measurement of prostate specific antigen (PSA) and is to be use as an aid in the management of patients with prostate cancer.
- Both assays use mouse monoclonal antibodies to bind PSA molecules. .
- Both assays are based on two-site immunometric assay technique (sandwich assays). .
- Both assays use human serum for the test specimen. ●
- The sensitivity of the two assays are similar (0.1 ng/mL). ●
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Differences:
| Feature: | Nichols Advantage™ PSA | Hybritech Tandem®-R PSA |
|---|---|---|
| Sample Size | 20uL | 50uL |
| Detection Method | Acridinium labeled antibody. | |
| RLU is the signal. | 125I labeled antibody | |
| Gamma radiation in CPM is the signal. | ||
| Instrument | ||
| Requirements | Nichols Advantage Specialty | |
| System | Gamma Photon System or gamma | |
| counter. | ||
| Calibration: | Full calibration curve every 2 | |
| weeks with 2 point calibration | ||
| every 4 hours. | Full calibration curve with every | |
| run. | ||
| Standardization | Stamey/Stanford Reference | |
| Standard (90% PSA-ACT + 10% | ||
| free PSA) | Different reference material. | |
| Solid Phase: | Streptavidin magnetic particles. | |
| Streptavidin-biotin separation | ||
| technology. | Coated beads with anti-PSA | |
| monoclonal antibody. | ||
| Reportable Range | 0-30 ng/mL | 0-100 ng/mL |
:
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Performance Characteristics:
| Feature: | Nichols Advantage™ PSA | Hybritech Tandem®-R PSA | ||||
|---|---|---|---|---|---|---|
| Precision: | ||||||
| Intra-Assay: | Intra-Assay: | |||||
| Level | Pool 1 | Pool 2 | Pool 3 | 1 | 2 | 3 |
| N | 20 | 20 | 20 | 40 | 40 | 40 |
| Mean (ng/mL) | 0.6 | 3.9 | 23.6 | 5.25 | 26.8 | 78.9 |
| %CV | 6.1 | 2.3 | 2.7 | 4.4 | 4.8 | 4.3 |
| Inter-Assay: | Inter-Assay: | |||||
| Level | Pool 4 | Pool 5 | Pool 6 | 1 | 2 | 3 |
| N | 20 | 20 | 20 | 40 | 40 | 40 |
| Mean (ng/mL) | 0.7 | 4.2 | 27.7 | 5.2 | 27.3 | 79.6 |
| %CV | 9.8 | 3.6 | 9.1 | 5.4 | 4.2 | 2.4 |
| Sensitivity | 0.1 ng/mL | 0.1 ng/mL | ||||
| High Dose Hook | no hook effect up to 5,000 ng/mL | no hook effect up to 5,000 ng/mL | ||||
| Recovery | 93-106% | 92-95% | ||||
| Parallelism | 89-108% | not available | ||||
| Interfering Subtances: | No interference up to: | No interference up to: | ||||
| hemoglobin | 800 mg/dL | 200 mg/dL | ||||
| bilirubin | 25 mg/dL | 25 mg/dL | ||||
| lipemia(triglycerides) | 2325 mg/dL | 2320 mg/dL | ||||
| PAP | 1,000 ng/mL | 1,000 ng/mL | ||||
| Method Comparison | versus Hybritech Tandem-R PSA | |||||
| n=183 split samples | ||||||
| Range of values 0.1 to 24.6 ng/mL (Hybritech) | ||||||
| Range of values 0.1 to 22.3 ng/mL (Nichols) | ||||||
| y = 0.974x + 0.25 (Deming linear regression) | ||||||
| 95% confidence of the slope: 0.906 - 1.042 | ||||||
| 95% confidence of the intercept: -0.34 to 0.84 | ||||||
| R = 0.885 |
'
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and features the department's name around the perimeter. In the center is a stylized symbol that resembles a caduceus, a symbol often associated with healthcare.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Nichols Institute Diagnostics c/o Ms. Cindy Martin Regulatory Consultant 1711 North Bush Street Santa Ana, California 92706
APR - 3 1998
Re: к980716
Nichols Institute Diagnostics ADVANTAGE™ Trade Name: Chemiluminescence Prostate Specific Antigen (PSA) Immunoassay
Regulatory Class: II Product Code: LTJ Dated: January 5, 1998 Received: January 7, 1998
Dear Ms. Martin:
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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current: Good: Manufacturing: Practice: requirement; as set forth was now 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 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
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INDICATIONS FOR USE STATEMENT
11-880116 K965031
510(K) Number (if known):
Nichols Advantage™ Chemiluminescence Assay Prostate Specific Device Name: Antigen
Indications For Use:
Intended for use with the Nichols Advantage Specialty System for the quantitative determination of prostate specific antigen (PSA) in human serum and is to be used as an adjunct in the management of patients with prostate cancer.
Peter E. Maples
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number -
( 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)
OR
Over-The-Counter Use (Optional Format 1-2-96)
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