(75 days)
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.
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.
Here's a summary of the acceptance criteria and the study that proves the Nichols Advantage QuiCk-IntraOperative™ Bio-Intact PTH (1-84) device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a set of pass/fail thresholds. Instead, it presents performance characteristics of the new device and compares them to a predicate device to demonstrate substantial equivalence. The implication is that performance comparable to the predicate device is considered acceptable.
| Feature | Acceptance Criteria (Implied: Comparable to Predicate) | QuiCk-IntraOperative PTH Performance | Predicate Device (Bio-Intact PTH (1-84)) Performance |
|---|---|---|---|
| Method Comparison | Y = 1.00X - 1.1; r = 0.99 (Passing Bablok) | Y = 1.00X - 1.1 (95% CI: 0.97-1.03 slope, -2.9 to +0.8 intercept) | N/A (predicate itself) |
| Pearson's Correlation (r) | r = 0.99 (Implicitly acceptable) | 0.99 | N/A |
| Range of values measured | Comparable to predicate | 12.3 to 792 pg/mL | 10.8 to 773 pg/mL |
| Functional Sensitivity | Comparable to predicate | 12 pg/mL | 4 pg/mL |
| Analytical Sensitivity | Comparable to predicate | 5 pg/mL | 1.5 pg/mL |
| Within-Run Precision (%CV) | Comparable to predicate | 3.9-16.1% | 2.2-3.6% |
| Total Precision (%CV) | Comparable to predicate | 5.8-22.6% | 5.6-8.3% |
| Recovery | Comparable to predicate | 94-117% | 94-103% |
| Linearity | Comparable to predicate | 99-111% | 92-109% |
Note: While the new device's functional and analytical sensitivity, and precision, are numerically different from the predicate, the conclusion states that the data demonstrates "safety and effectiveness" and "substantial equivalence." This implies that these differences were deemed acceptable within the context of the intended use, likely because the performance characteristics are still clinically appropriate for rapid intraoperative measurement.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: One hundred thirty (130) remnant serum samples.
- Data Provenance: The clinical diagnosis for these samples was "unknown," indicating they were likely de-identified samples from a clinical laboratory or biobank. The country of origin is not specified but is presumed to be the USA, given the manufacturer's location and the FDA submission. The study appears to be retrospective as it used "remnant serum samples."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The study primarily focuses on comparing the new device's measurements to those of the predicate device, which serves as the reference or "ground truth" for the comparison. There's no indication that external experts were used to establish ground truth for the 130 samples beyond what the predicate device provided.
4. Adjudication Method for the Test Set:
This information is not provided. The comparison involved running each sample "in duplicate by both methods." There's no mention of an adjudication process for discrepancies beyond duplicate measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This device is an immunoassay (laboratory test), not an imaging or diagnostic device that typically involves human "readers." The study evaluates the analytical performance of the assay itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This device is an in vitro diagnostic immunoassay, which by nature is a standalone (algorithm only/device only) test. Its performance is measured independently of human interpretation in the sense of a radiologist reading an image. The study assesses the device's ability to accurately measure PTH concentrations.
7. The Type of Ground Truth Used:
The "ground truth" for the comparative study was established by the predicate device, Nichols Advantage Bio-Intact PTH (1-84) assay. The study aims to show substantial equivalence to this already-cleared device. The clinical diagnosis of the samples was unknown, so it was not directly based on pathology or patient outcomes for this specific comparative study.
8. The Sample Size for the Training Set:
This information is not provided. The document describes a comparison study for regulatory submission of an already developed device. It does not detail the development or training of the assay itself.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided. As explained above, the document focuses on the validation for regulatory submission, not the initial development or "training" of the assay.
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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
§ 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.