(14 days)
No
The summary describes a competitive binding assay for measuring aldosterone levels, which is a standard laboratory technique and does not mention any AI or ML components.
No.
The device is an assay intended to quantitatively measure aldosterone, which is used in the diagnosis of various conditions. It does not provide any treatment or therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is used "in the diagnosis and treatment of primary aldosteronism...and other conditions of electrolyte imbalance." This directly indicates its role in diagnosis.
No
The device description explicitly states it contains "sufficient reagents for 100 tests" and is a "competitive binding assay," indicating it is a chemical assay kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the assay is used to "quantitatively measure aldosterone in human serum and EDTA plasma." This involves testing samples taken from the human body (in vitro) to provide information for diagnosis and treatment.
- Device Description: The description mentions it's a "competitive binding assay for aldosterone in human serum or plasma," further confirming it's a test performed on biological samples outside the body.
- Performance Studies: The performance studies involve testing "remnant serum samples," which are biological samples.
- Key Metrics: The key metrics listed (analytical sensitivity, precision, recovery, linearity) are all standard performance characteristics evaluated for in vitro diagnostic assays.
- Predicate Device: The comparison to a "Predicate Device" which is an "Aldosterone RIA" (Radioimmunoassay) is typical for IVD submissions to regulatory bodies like the FDA.
All of these points strongly indicate that the Nichols Advantage® Aldosterone assay is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nichols Advantage® Aldosterone assay is intended for use with the Nichols Advantage Specialty System to quantitatively measure aldosterone in human serum and EDTA plasma. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by excessive secretion of aldosterone by the gland), hypertension caused by primary aldosteronism, selective adrenal hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.
Product codes
CJM, JIS, JJX
Device Description
The Nichols Advantage® Aldosterone assay contains sufficient reagents for 100 tests. The assay is a competitive binding assay for aldosterone in human serum or plasma.
Mentions image processing
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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
The Nichols Advantage® Aldosterone (Y) was compared to the DPC Coat-A-Count Aldosterone RIA (X) previously cleared by the FDA (K831178, 5/27/83). One hundred three (103) remnant serum samples in which the clinical diagnosis were unknown were assaved in duplicate by both methods following each manufacturers' directions. The range observed with method "X" was 2.7 to 125 ng/dL; range for method "Y" was 2.7 to 120 ng/dL. Passing Bablok regression analysis of these data yielded an equation of Y = 1.04X + 0.1 (95% confidence intervals for slope and intercept were 0.98 to 1.10, and -1.0 to +1.1 respectively). Deming regression analysis of these data yielded an equation of Y = 1.09X - 0.6 (95% confidence intervals for slope and intercept were 1.03 to 1.15, and -3.2 to +2.1 respectively). Pearson's correlation coefficient (r) of the paired data was 0.96.
Comparison of Performance Characteristics:
Within-Run Precision (%CV): Nichols Aldosterone 2.9-14.0%, DPC Aldosterone 2.3-5.4%
Total Precision (%CV): Nichols Aldosterone 4.9-18.6%, DPC Aldosterone 3.8-15.7%
Recovery: Nichols Aldosterone 88-110%, DPC Aldosterone 86-111%
Linearity: Nichols Aldosterone 91-116%, DPC Aldosterone 100-119%
Conclusions: These data, which were provided to FDA, demonstrate safety and effectiveness of the Nichols Advantage® Aldosterone for its intended in vitro diagnostic use. Furthermore, based on performance characteristics, the Nichols Advantage® Aldosterone assay is substantially equivalent to the predicate method.
Key Metrics
Pearson's correlation coefficient (r) of the paired data was 0.96.
Within-Run Precision (%CV): Nichols Aldosterone 2.9-14.0%, DPC Aldosterone 2.3-5.4%
Total Precision (%CV): Nichols Aldosterone 4.9-18.6%, DPC Aldosterone 3.8-15.7%
Recovery: Nichols Aldosterone 88-110%, DPC Aldosterone 86-111%
Linearity: Nichols Aldosterone 91-116%, DPC Aldosterone 100-119%
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1045 Aldosterone test system.
(a)
Identification. An aldosterone test system is a device intended to measure the hormone aldosterone in serum and urine. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by the excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.(b)
Classification. Class II.
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Ko32188
JUL 3 1 2003
510(k) Notification Nichols Advantage Aldosterone Date: 07/11/03 (revised)
Concluding 510(k) Summary 12.0
This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1. Name of Manufacturer, Contact Person and Date Summary Prepared:
Nichols Institute Diagnostics 1311 Calle Batido San Clemente, CA 92673 Phone: 949-940-7260 FAX: 949-940-7313 Contact Person: Jimmy Wong, Manager of Clinical and Technical Affairs Date Prepared: July 11, 2003
FOOD AND DRUG BRANCH
2. Device Name:
.
| Trade/Proprietary Name: | Nichols Advantage® Aldosterone |
|---|---|
| Common Name: | Aldosterone immunoassay |
| Classification Name: | Radioimmunoassay, Aldosterone |
-
Classification: " Class II 3.
Requlation Number: 862.1045 Product Code: CJM, Clinical Chemistry -
Diagnostic Product Corporation Coat-A-Count Aldosterone Predicate Device: 4.
5. Device Description:
The Nichols Advantage® Aldosterone assay contains sufficient reagents for 100 tests. The assay is a competitive binding assay for aldosterone in human serum or plasma.
Intended Use: 6.
The Nichols Advantage® Aldosterone assay is intended for use with the Nichols Advantage Specialty System to quantitatively measure aldosterone in human serum and EDTA plasma. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by excessive secretion of aldosterone by the gland), hypertension caused by primary aldosteronism, selective adrenal hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.
7. Comparison to Predicate Device:
The Nichols Advantage® Aldosterone (Y) was compared to the DPC Coat-A-Count Aldosterone RIA (X) previously cleared by the FDA (K831178, 5/27/83). One hundred three (103) remnant serum samples in which the clinical diagnosis were unknown were assaved in duplicate by both methods following each manufacturers' directions. The range observed with method "X" was 2.7 to 125 ng/dL; range for method "Y" was 2.7 to 120 ng/dL. Passing Bablok regression analysis of these data yielded an equation of Y = 1.04X + 0.1 (95% confidence intervals for slope and intercept were 0.98 to 1.10, and -1.0 to +1.1 respectively). Deming regression analysis of these data yielded an equation of Y = 1.09X - 0.6 (95% confidence intervals for slope and intercept were 1.03 to 1.15, and -3.2 to +2.1 respectively). Pearson's correlation coefficient (r) of the paired data was 0.96.
8. Similarities:
- Specimen type is identical for both methods. .
- . Both assays use human aldosterone standards, and both report values using the same units: ng/dL.
- Both assays use a specific antibody to aldosterone, use competitive protein binding with ● labeled aldosterone to measure the hormone directly in serum or plasma samples.
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9. Differences:
..
The following differences pertain to differences in immunoassay technology and do not affect the intended uses of each assay.
| Feature | Nichols Aldosterone | DPC Aldosterone |
|---|---|---|
| Sample Size: | 250 uL serum or EDTA plasma | 200 µL serum or plasma |
| Binding Technology | Magnetic particles - avidin coated | Antibody coated tubes |
| Incubation steps and temperature: | 3 steps, 10 minutes each @ 37℃ | 18 hours @ 15-28°C |
| Analytical sensitivity | 1.2 ng/dL | 1.1 ng/dL |
| Sample Bias | EDTA values are lower | EDTA values are higher |
10. Comparison of Performance Characteristics
| Feature | Nichols Aldosterone | DPC Aldosterone | |
|---|---|---|---|
| Within-Run Precision (%CV) | 2.9-14.0% | 2.3-5.4% | |
| Total Precision (%CV) | 4.9-18.6% | 3.8-15.7% | |
| Recovery | 88-110% | 86-111% | |
| Linearity | 91-116% | 100-119% |
Conclusions: These data, which were provided to FDA, demonstrate safety and effectiveness of the Nichols Advantage® Aldosterone for its intended in vitro diagnostic use. Furthermore, based on performance characteristics, the Nichols Advantage® Aldosterone assay is substantially equivalent to the predicate method.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is composed of three parallel lines that curve and flow, resembling a stylized representation of a staff with snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Public Health Service
JUL 3 1 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Nichols Institute Diagnostics c/o Alfredo J. Ouattrone. Ph.D., DABT California Department of Health Food & Drug Branch P.O. Box 942732 (MS-357) Sacramento, CA 94234
Re: K032188
Trade/Device Name: Nichols Advantage Aldosterone Regulation Number: 21 CFR 862,1045 Regulation Name: Aldosterone test system Regulatory Class: Class II Product Code: CJM; JIS; JJX Dated: July 15, 2003 Received: July 17, 2003
Dear Dr. Quattrone:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
510(k) Notification Nichols Advantage Aldosterone Date: 07/11/03
Indications For Use Statement 4.0
INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K032188 |
|---|---|
| ---------------- | --------- |
Nichols Advantage Aldosterone Device Name:
Indications for Use Statement: The Nichols Advantage® Aldosterone assay is intended for use with the Nichols Advantage® Specialty System to quantitatively measure aldosterone in human serum and EDTA plasma. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.
Jean Cooper
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K032188
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rrescription Use (Per 21 CFR 801.109)
Or
Over -The-Counter Use (Optional Format 1-2-96)