(391 days)
Not Found
No
The device description details a standard chemiluminescence immunoassay and data processing based on a calibration curve, with no mention of AI or ML techniques.
No
This device is an in vitro diagnostic (IVD) device used for quantitative determination of erythropoietin concentrations, which aids in diagnosis rather than directly treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended "for the quantitative determination of erythropoietin concentrations in human serum as an adjunct in the diagnosis of anemia and polycythemia." The phrase "as an adjunct in the diagnosis" clearly indicates its role as a diagnostic tool.
No
The device description clearly outlines a chemiluminescence immunoassay that involves physical reagents, incubation steps, magnetic particles, and a luminometer to quantify light emission. This is a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states that the assay is for the "quantitative determination of erythropoietin concentrations in human serum as an adjunct in the diagnosis of anemia and polycythemia." This clearly indicates that the device is intended to be used in vitro (outside the body) to examine specimens (human serum) for the purpose of providing information for diagnosis.
- Device Description: The description details a laboratory assay process involving chemical reactions (chemiluminescence) and the analysis of a biological sample (serum). This is characteristic of an in vitro diagnostic test.
- Performance Studies: The inclusion of performance characteristics like precision, recovery, parallelism, specificity, and method comparison are standard for IVD devices, demonstrating their analytical performance on biological samples.
N/A
Intended Use / Indications for Use
The Advantage Chemiluminescence Erythropoietin Immunoassay is intended for use with the Advantage Specially System for the quantitative determination of erythropoietin concentrations in human serum as an adjunct in the diagnosis of anemia and polycythemia.
Product codes (comma separated list FDA assigned to the subject device)
GGT
Device Description
The Nichols Advantage™ EPO assay is a two-site chemiluminescence assay. Total assay duration is 30 minutes at 37°C.
14 Incubation: 20 minutes at 37℃. Sample or control (200uL), biotinylated polyclonal antibody (40uL), acridinium labeled mouse monoclonal antibody (10uL) are pipetted into a reaction well on the cuvette strip. Each antibody binds to a separate and distinct antigenic site on EPO to form a sandwich complex.
204 Incubation: 10 minutes at 37°C. Streptavidin coated magnetic particles (20uL) are added to the reaction mixture. After the 10 minute incubation, the sandwich complex is bound to the solid phase via the high affinity interaction of blotin and streptavidin. The reaction mixture is aspirated from the reaction well after the streptavidin magnetic particles are magnetically capfured onto the surface of the reaction well wall.
Acridinum 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 sodium hydroxide. The system automatically injects Trigger 1 and 2 into the reaction well which oxidizes 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 EPO 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
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)
Comparison of Performance Characteristics With Predicate Device:
The Nichols Advantage™ EPO is substantially equivalent to other products in commercial distribution for similar use.
Similarities:
- Intended Use: For the quantitative determination of erythropoletin levels in human serum as . an adjunct in the diagnosis of anemia and polycythemia.
- Both assays use specific antibodies to EPO. .
- Both assays use human serum for the test sample. ●
- . The sensitivity of both assays are nearly the same, and both assays are standardized to the same WHO Standard (1ª IS 87/684) for recombinant DNA derived erythropoietin.
- Recombinant EPO is used as standards in both assays. .
- The upper end of the normal range is similar at the 95% confidence level.
Differences:
| Feature | Nichols Advantage™ Immunoassay | Nichols Institute Diagnostics Chemiluminescence EPO kit |
|---|---|---|
| Sample Size | 200 uL | 100 uL |
| Calibration | Full calibration curve every week with 2 point calibration every 4 hours. | Full standard curve with every assay run. |
| Solid Phase | Streptavidin coated magnetic particles. | Avidin coated bead. |
| Dynamic Range | 5-700 mU/mL | 1.4-1500 mU/mL |
| Incubation | Total of 30 minutes at 37°C | Total of 4 hours at room temperature (15-30°C) |
| Assay Counting | Automated on-board instrument | Semi-automated luminometer. |
| Assay Washing | Automated on-board instrument | Separate semi-automated wash instrument. |
Performance Characteristics:
| Feature | Nichols Advantage™ EPO (NCCLS Protocol) | Nichols Assay kit. |
|---|---|---|
| Precision - Within-Run: Mean (mU/mL) / No of Reps. / %CV | 12.5 / 66 / 10.4, 92 / 66 / 3.3, 168 / 66 / 2.6, 502 / 66 / 4.5 | 19.8 / 20 / 5.4, 152 / 20 / 3.2, 310 / 20 / 2.4, 544 / 20 / 2.7 |
| Precision - Total Precision: Mean (mU/mL) / No of Reps. / %CV | 12.5 / 66 / 13.6, 92 / 66 / 5.5, 168 / 66 / 3.8, 502 / 66 / 5.6 | 21.8 / 20 / 9.7, 160 / 20 / 6.1, 294 / 20 / 5.3, 544 / 20 / 3.7 |
| Recovery | 87-111% | 93-120% |
| Parallelism | 91-116% | 84-108% |
| High Dose Hook | 7,500 mU/mL | 50,000 mU/mL |
| Specificity & Crossreactivity*: Human Transferrin @10 mg/mL, Human α-2-Macroglobulin @ 8.3 mg/mL, Human α-1-Acid Glycoprotein @8.3 mg/mL, Human α-1-Antitryspin @10 mg/mL |
§ 864.7250 Erythropoietin assay.
(a)
Identification. A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and anemia.(b)
Classification. Class II. The special control for this device is FDA's “Document for Special Controls for Erythropoietin Assay Premarket Notification (510(k)s).”
0
3/22/99
510(k) 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: K980737
- Name of Submitter, Contact Person and Date Summary Prepared: 1.
Jimmy Wong Nichols Institute Diagnostics 33051 Calle Aviador San Juan Capistrano, California 92675 Phone: (714) 240-5260 (714) 240-5313 Fax:
Summary Prepared On: March 18, 1999
-
- Device Name;
Trade/Proprietary Name: Nichols Advantage® Chemiluminescence Erythropoletin Immunoassav Erythropoietin Assay Common/Usual Name: Ervthropoletin Assay Classification Name:
- Device Name;
-
- Legally Marketed Equivalent Device Name:
We are claiming substantial equivalence to the assay cleared in Nichols Institute Diagnostics' 510(k) K952559 for the Chemiluminescence Erythropoletin Immunoassay Kit.
- Legally Marketed Equivalent Device Name:
-
Description of the Device: 4.
The Nichols Advantage™ EPO assay is a two-site chemiluminescence assay. Total assay duration is 30 minutes at 37°C.
14 Incubation: 20 minutes at 37℃. Sample or control (200uL), biotinylated polyclonal antibody (40uL), acridinium labeled mouse monoclonal antibody (10uL) are pipetted into a reaction well on the cuvette strip. Each antibody binds to a separate and distinct antigenic site on EPO to form a sandwich complex.
204 Incubation: 10 minutes at 37°C. Streptavidin coated magnetic particles (20uL) are added to the reaction mixture. After the 10 minute incubation, the sandwich complex is bound to the solid phase via the high affinity interaction of blotin and streptavidin. The reaction mixture is aspirated from the reaction well after the streptavidin magnetic particles are magnetically capfured onto the surface of the reaction well wall.
Acridinum 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 sodium hydroxide. The system automatically injects Trigger 1 and 2 into the reaction well which oxidizes the acridinium ester. The oxidized product is in an excited state. The subsequent return to ground state results in the emission of light which
1
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 EPO 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.
ર્ડ Intended Use of the Device
The Advantage Chemiluminescence Erythropoietin Immunoassay is intended for use with the Advantage Specially System for the quantitative determination of erythropoietin concentrations in human serum as an adjunct in the diagnosis of anemia and polycythemia.
Comparison of technological characteristics With Predicate Davice ર.
The Advantage Chemiluminescence Erythropoletin (EPO) Immunoassay is substantially equivalent in intended use to results obtained using the predicate device. Both assays use a labeled antibody for the quantitative measurement of EPO in serum. The major difference in the assays is that the subject device uses streptavidin coated magnetic particle In the capture separation phase of the assay; whereas, the predicate device uses an avidin coated bead as the separation system.
Companson of Performance Characteristics With Predicate Device 7.
The Nichols Advantage™ EPO is substantially equivalent to other products in commercial distribution for similar use. The following tables compare the Nichols Advantage™ EPO with the predicate device, Nichols Chemiluminescence EPO kit.
Similarities:
- Intended Use: For the quantitative determination of erythropoletin levels in human serum as . an adjunct in the diagnosis of anemia and polycythemia.
- Both assays use specific antibodies to EPO. .
- Both assays use human serum for the test sample. ●
- . The sensitivity of both assays are nearly the same, and both assays are standardized to the same WHO Standard (1ª IS 87/684) for recombinant DNA derived erythropoietin.
- Recombinant EPO is used as standards in both assays. .
- The upper end of the normal range is similar at the 95% confidence level.
Differences:
| Feature | Nichols Advantage™
Immunoassay | Nichols Institute Diagnostics
Chemiluminescence EPO kit |
|----------------|---------------------------------------------------------------------------------|------------------------------------------------------------|
| Sample Size | 200 uL | 100 uL |
| Calibration | Full calibration curve every week
with 2 point calibration every 4
hours. | Full standard curve with every assay
run. |
| Solid Phase | Streptavidin coated magnetic
particles. | Avidin coated bead. |
| Dynamic Range | 5-700 mU/mL | 1.4-1500 mU/mL |
| Incubation | Total of 30 minutes at 37°C | Total of 4 hours at room
temperature (15-30°C) |
| Assay Counting | Automated on-board instrument | Semi-automated luminometer. |
| Assay Washing | Automated on-board instrument | Separate semi-automated wash
instrument. |
2
| Performance Characteristics: | Nichols Chemiluminescence EPO | ||||||
|---|---|---|---|---|---|---|---|
| Feature | Nichols Advantage™ EPO | Nichols Assay kit. | |||||
| (NCCLS Protocol) | |||||||
| Precision | Mean | ||||||
| (mU/mL) | No of | ||||||
| Reps. | %CV | Mean | |||||
| (mU/mL) | N | %CV | |||||
| Within-Run | 12.5 | 66 | 10.4 | 19.8 | 20 | 5.4 | |
| 92 | 66 | 3.3 | 152 | 20 | 3.2 | ||
| 168 | 66 | 2.6 | 310 | 20 | 2.4 | ||
| 502 | 66 | 4.5 | 544 | 20 | 2.7 | ||
| Total Precision | 12.5 | 66 | 13.6 | 21.8 | 20 | 9.7 | |
| 92 | 66 | 5.5 | 160 | 20 | 6.1 | ||
| 168 | 66 | 3.8 | 294 | 20 | 5.3 | ||
| 502 | 66 | 5.6 | 544 | 20 | 3.7 | ||
| Recovery | 87-111% | 93-120% | |||||
| Parallelism | 91-116% | 84-108% | |||||
| High Dose Hook | 7,500 mU/mL | 50,000 mU/mL | |||||
| Specificity & Crossreactivity*: | |||||||
| Human Transferrin @10 mg/mL | |||||||
| Human α-2-Macroglobulin @ 8.3 mg/mL | |||||||
| Human α-1-Acid Glycoprotein @8.3 mg/mL | |||||||
| Human α-1-Antitryspin @10 mg/mL | Trade Name: Nichols Advantage® Chemiluminescence Erythropoietin Immunoassay Requlatory Class: III Product Code: GGT December 23, 1998 Dated: December 28, 1998 Received: |
Dear Mr. Wong:
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 aqainst 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. this response to your premarket notification Please note: 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 requlations.
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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrl/dsma/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
7
Indications For Use Statement 4.0
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Nichols Advantage™ Chemiluminescence Erythropoietin Immunoassay
Indications For Use:
The Nichols Advantage™ Chemiluminescence Erythropoietin Immunoassay is intended for use with the Nichols Advantage™ Specialty System for the quantitative determination of erythropoietin concentrations in human serum as an adjunct in the diagnosis of anemia and polycythemia.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | 1980739 |
| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---|---|
| --------------------------------------- | -------------- |
OR
| Over-The-Counter Use (Optional Format 1-2-96) |
|---|
| ----------------------------------------------- |
Febraury 18, 1998