(75 days)
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No
The summary describes a standard in vitro diagnostic assay based on chemiluminometric technology, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is an in-vitro diagnostic (IVD) assay designed to measure parathyroid hormone levels, not to provide therapy or treatment.
Yes
The device is an in vitro diagnostic (IVD) device designed to measure parathyroid hormone levels in patient samples, which is a diagnostic function. The Intended Use section explicitly states it "measure[s] parathyroid hormone..." and the Summary of Performance Studies describes comparison to a predicate device, consistent with a diagnostic purpose.
No
The device description clearly states it is an "assay" containing "reagents" and a "reagent cartridge," which are physical components, not software. It is an in vitro diagnostic device that measures a substance in a biological sample.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use with the Nichols Advantage® Specialty System to measure parathyroid hormone in EDTA plasma and human serum." This clearly indicates that the device is used to perform tests on samples taken from the human body (in vitro) to provide information about a person's health status (diagnostic).
- Device Description: The description mentions it's an "assay," which is a common term for a laboratory test used in IVD devices. It also describes the type of assay (two-site chemiluminometric assay) and what it measures (hPTH 1-84), further supporting its role as a diagnostic tool.
- Input Imaging Modality: The entry explicitly states "Not Applicable (In vitro diagnostic device)," which directly identifies it as an IVD.
- Anatomical Site: Similarly, "Not Applicable (In vitro diagnostic device)" confirms its nature as an IVD.
The information provided aligns perfectly with the definition of an In Vitro Diagnostic device, which is a medical device used to perform tests on samples taken from the human body to detect diseases, conditions, or infections.
N/A
Intended Use / Indications for Use
The Nichols Advantage QuiCk-IntraOperative Bio-Intact PTH (1-84) is intended for use with the Nichols Advantage Specialty System to measure parathyroid hormone in EDTA plasma and human serum. This procedure is recommended for rapid intraoperative measurement of Intact PTH 1-84 using EDTA plasma or human serum. The reagent cartridge is designed for single use only.
Product codes (comma separated list FDA assigned to the subject device)
CEW
Device Description
The Nichols Advantage QuiCk-IntraOperative Bio-Intact PTH (1-84) assay contains sufficient reagents for 26 tests. The assay is a two-site chemiluminometric assay specific for hPTH 1-84.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Nichols Advantage QuiCk-IntraOperative Bio-Intact PTH (1-84) (Y) was compared to the Nichols Advantage Bio-Intact PTH (1-84) assay (X) previously cleared by the FDA. One hundred thirty (130) remnant serum samples in which the clinical diagnosis were unknown were assayed in duplicate by both methods following the manufacturers' directions. The range observed with method "X" was 10.8 to 773 pg/mL; range for method "Y" was 12.3 to 792 pg/mL. Passing Bablok regression analysis of these data yielded an equation of Y = 1.00X - 1.1 (95% confidence intervals for slope and intercept were 0.97 to 1.03, and -2.9 to +0.8 respectively). Deming regression analysis of these data yielded an equation of Y = 0.985X - 0.3 (95% confidence intervals for slope and intercept were 0.96 to 1.01, and -4.6 to +3.9 respectively). Pearson's correlation coefficient (r) of the paired data was 0.99.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical sensitivity: QuiCk-IntraOperative PTH 5 pg/mL, Bio-Intact PTH (1-84) 1.5 pg/mL.
Functional sensitivity: QuiCk-IntraOperative PTH 12 pg/mL, Bio-Intact PTH (1-84) 4 pg/mL.
Within-Run Precision (%CV): QuiCk-IntraOperative PTH 3.9-16.1%, Bio-Intact PTH (1-84) 2.2-3.6%.
Total Precision (%CV): QuiCk-IntraOperative PTH 5.8-22.6%, Bio-Intact PTH (1-84) 5.6-8.3%.
Recovery: QuiCk-IntraOperative PTH 94-117%, Bio-Intact PTH (1-84) 94-103%.
Linearity: QuiCk-IntraOperative PTH 99-111%, Bio-Intact PTH (1-84) 92-109%.
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.
Nichols Advantage Bio-Intact PTH (1-84)
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.
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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).
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§ 862.1545 Parathyroid hormone test system.
(a)
Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.(b)
Classification. Class II.
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Nichols Advantage QuiCk-IntraOperative™ Bio-Intact Date: 07/24
12.0 510(k) Summary
This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Name of Manufacturer, Contact Person and Date Summary Prepared: 1.
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 22, 2002
2. Device Name:
Trade/Proprietary Name:
Nichols Advantage® QuiCk-IntraOperative Bio-Intact PTH (1-84) Common Name: Intraoperative PTH Immunoassay Classification Name: Parathyroid hormone test system Classification: Class II 3. Requlation Number: 862.1545 Product Code: CEW, Clinical Chemistry
- Predicate Device: Nichols Advantage Bio-Intact PTH (1-84) 4.
5. Device Description:
The Nichols Advantage QuiCk-IntraOperative Bio-Intact PTH (1-84) assay contains sufficient reagents for 26 tests. The assay is a two-site chemiluminometric assay specific for hPTH 1-84.
6. Intended Use:
The Nichols Advantage QuiCk-IntraOperative Bio-Intact PTH (1-84) is intended for use with the Nichols Advantage Specialty System to measure parathyroid hormone in EDTA plasma and human serum. This procedure is recommended for rapid intraoperative measurement of Intact PTH 1-84 using EDTA plasma or human serum. The reagent cartridge is designed for single use only.
7. Comparison to Predicate Device:
The Nichols Advantage QuiCk-IntraOperative Bio-Intact PTH (1-84) (Y) was compared to the Nichols Advantage Bio-Intact PTH (1-84) assay (X) previously cleared by the FDA. One hundred thirty (130) remnant serum samples in which the clinical diagnosis were unknown were assayed in duplicate by both methods following the manufacturers' directions. The range observed with method "X" was 10.8 to 773 pg/mL; range for method "Y" was 12.3 to 792 pg/mL. Passing Bablok regression analysis of these data yielded an equation of Y = 1.00X - 1.1 (95% confidence intervals for slope and intercept were 0.97 to 1.03, and -2.9 to +0.8 respectively). Deming regression analysis of these data yielded an equation of Y = 0.985X - 0.3 (95% confidence intervals for slope and intercept were 0.96 to 1.01, and -4.6 to +3.9 respectively). Pearson's correlation coefficient (r) of the paired data was 0.99.
8. Similarities:
- . Specimen type is identical for both methods.
- . Both assays use hPTH 1-84 as standards, and both report values using the same units: pg/mL.
Date Printed: 07/24/02 Created by: Jimmy Wong
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- . Both assays use the same immunometric approach to measure PTH, and both assay methods use the same antibody pair for capture and detection of the hormone.
9. Differences:
The following differences pertain to differences in immunoassay technology and do not affect the intended uses of the PTH assay.
| Feature | QuiCk-IntraOperative PTH | Bio-Intact PTH (1-84) |
|---|---|---|
| Sample Size: | 250 uL EDTA plasma or serum | 150 uL serum or plasma |
| Incubation steps and temperature: | 2 minutes @ 37°C | 30 minutes @ 37°C |
| Analytical sensitivity | 5 pg/mL | 1.5 pg/mL |
| Functional sensitivity | 12 pg/mL | 4 pg/mL |
10. Comparison of Performance Characteristics
| Feature | QuiCk-IntraOperative PTH | Bio-Intact PTH (1-84) |
|---|---|---|
| Within-Run Precision (%CV) | 3.9-16.1% | 2.2-3.6% |
| Total Precision (%CV) | 5.8-22.6% | 5.6-8.3% |
| Recovery | 94-117% | 94-103% |
| Lineanty | 99-111% | 92-109% |
Conclusions: These data, which were provided to FDA, demonstrate safety and effectiveness of the Nichols Advantage QuiCk-IntraOperative Bio-Intact PTH (1-84) for its intended in vitro diagnostic use. Furthermore, based on performance characteristics, the Nichols Advantage QuiCk-IntraOperative Bio-Intact PTH (1-84) assay is substantially equivalent to the predicate method.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 0 9 2002
Mr. Jimmy Wong Manager, Clinical and Technical Affairs Nichols Institute Diagnostics 1311 Calle Batido San Clemente, CA 92673
Re: K022472
Trade/Device Name: Nichols Advantage QuiCk-IntraOperative™ Bio-Intact PTH (1-84) Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: Class II Product Code: CEW Dated: July 24, 2002 Received: July 26, 2002
Dear Mr. Wong:
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.
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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" (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/cdrb/dsmaldsmamain.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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4.0 Indications For Use Statement
INDICATIONS FOR USE STATEMENT
510(k) Number:
022412
Nichols Advantage QuiCk-IntraOperative™ Bio-Intact PTH (1-84) Device Name:
Indications for Use Statement: The Nichols Advantage QuiCk-IntraOperative1M Bio-Intact PTH (1-84) is intended for use with the Nichols Advantage® Specialty System to measure parathyroid hormone in EDTA plasma and human serum. This procedure is recommended for rapid intraoperative measurement of Intact PTH 1-84 using EDTA plasma or human serum. The reagent cartridge is designed for single use only.
(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)
Alan Cooper
ion Sign-Off of Clinical Labora
Date Printed: 07/24/02 Created by: Jimmy Wong