(79 days)
No
The summary describes a standard immunochemiluminometric assay for measuring H-hCG. There is no mention of AI, ML, or related concepts in the intended use, device description, performance studies, or key metrics. The technology described is a chemical assay, not a computational one involving AI/ML.
No
The device is an in vitro diagnostic assay used for the quantitative measurement of hyperglycosylated human chorionic gonadotropin (H-hCG) in human serum or for the qualitative determination of H-hCG in urine to aid in the detection of pregnancy. It does not directly provide therapy or treatment.
Yes
The device is intended for the quantitative measurement of H-hCG in human serum or the qualitative determination of H-hCG in urine as an aid in the detection of pregnancy. This directly supports a diagnostic purpose.
No
The device description explicitly states it is an "immunochemiluminometric assay" for use with a "Specialty System," indicating it is a laboratory-based test that involves physical reagents and instrumentation, not solely 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 measurement of hyperglycosylated human chorionic gonadotropin (H-hCG)... in human serum, or for the qualitative determination of H-hCG in urine as an aid in the detection of pregnancy." This involves testing samples taken from the human body (serum and urine) in vitro (outside the body) to provide information for a diagnosis (detection of pregnancy).
- Device Description: It describes an "immunochemiluminometric assay" used with a "Specialty System" for the "measurement of H-hCG as an aid in the detection of pregnancy." This is a laboratory-based test method.
- Sample Type: It uses human serum and urine samples.
- Care Setting: It is described as "Laboratory based products."
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay (or simply: Nichols Advantage® H-hCG Assay) is intended for use with the Nichols Advantage Specialty System for the quantitative measurement of hyperglycosylated human chorionic gonadotropin (H-hCG), a placental hormone in human serum, or for the qualitative determination of H-hCG in urine as an aid in the detection of pregnancy. These diagnoses should be made with appropriate additional clinical evidence. Clinical considerations and professional judgment should be applied to any test device result as with this Nichols H-hCG chemiluminescent immunoassay.
Product codes
DHA, JIT, JJX
Device Description
The Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin Assay (i.e., Nichols Advantage® H-hCG Assay) is a two-step, two-site immunochemiluminometric assay for use with the Nichols Advantage® Specialty System, for the measurement of H-hCG as an aid in the detection of pregnancy. This new Nichols Advantage® H-hCG Assay Jas with the predicate of the Diagnostic Products Corporation (= DPC) termed: the DPC IMMULITE® hCG Immunoassay (K990222; cleared 2/26/99)] is a two-step, two-site immunochemiluminometric assay for use with the Nichols Advantage® Specialty System.
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
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Intended User / Care Setting
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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)
Analytical performance:
Precision/Reproducibility: The Nichols Advantage® H-hCG Assay average total inter-assay precision was 6.7% C.V; the Acceptable Criteria was considered a high of: 7.22% C.V.
Linearity/assay reportable range: Linear regression correlation equation: Y(DPC's) = + 28.32X(NID's) -5.36 with correlation factor r= 0.935 (and P-Value
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.
0
510(k) Summary of Safety and Effectiveness 12.0
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: K042676
12.1. Name of Submitter, Contact Person and Date Summary Prepared:
Nichols Institute Diagnostics 1311 Calle Batido San Clemente, CA 92673 Phone: 949-940-7358 Fax: 949-940-7313
Contact Person: Xie Qiyi, MD., MPH Date Prepared: 7/21/2004
12.2. Device Name
| Trade/Proprietary Name: | Nichols Advantage® Hyperglycosylated Human Chorionic
Gonadotropin (H-hCG) Assay |
|-------------------------|------------------------------------------------------------------------------------|
| Common/Usual Name: | Nichols Advantage® H-hCG Assay |
| Classification Name: | System, Test, Human Chorionic Gonadotropin (hCG) |
12.3. Predicate Device
Substantial equivalence is claimed to the DPC's IMMULITE® hCG Immunoassay (K990222; Cleared 2/26/99).
12.4. Device Description
The Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin Assay (i.e., Nichols Advantage® H-hCG Assay) is a two-step, two-site immunochemiluminometric assay for use with the Nichols Advantage® Specialty System, for the measurement of H-hCG as an aid in the detection of pregnancy. This new Nichols Advantage® H-hCG Assay Jas with the predicate of the Diagnostic Products Corporation (= DPC) termed: the DPC IMMULITE® hCG Immunoassay (K990222; cleared 2/26/99)] is a two-step, two-site immunochemiluminometric assay for use with the Nichols Advantage® Specialty System.
12.5. Intended Use
The Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay (or simply: Nichols Advantage H-hCG Assay) is intended for use with the Nichols Advantage® Specialty System for the quantitative measurement of hyperglycosylated human chorionic gonadotropin (H-hCG), a placental hormone in human serum, or for the qualitative determination of H-hCG in urine as an aid in the detection of pregnancy. These diagnoses should be made with appropriate additional clinical evidence. Clinical considerations and professional judgment should
1
be applied to any test device result, particularly when preliminary positive results are obtained, as with this Nichols H-hCG chemiluminescent immunoassay.
The Nichols Advantage® H-hCG Assay is used in conjunction with two H-hCG calibrators which are used to calibrate the assay and are provided separately to the reagent cartridge. The control is used for the monitoring of the accuracy and precision of the Nichols Advantage HhCG Assay and successful calibration is confirmed using three H-hCG controls also provided separately to the calibrators and reagent cartridge.
Comparison to predicate device 12.6.
The Nichols Advantage® Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay is substantially equivalent to other laboratory based products in commercial distribution for similar use. Most notably, it is substantially equivalent to the DPC IMMULITE hCG Immunoassay. The following tables compare the Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay with the predicate device, the DPC IMMULITE hCG Immunoassay.
| Comparison Summary with Predicate Device | ||
|---|---|---|
| Similarities | ||
| Feature | Nichols Advantage H-hCG New Assay | DPC IMMULITE 2000 hCG Predicate Immunoassay |
| Antibody Recognition | Specific antibodies that bind isoforms of hCG | Specific antibodies that bind isoforms of hCG |
| Sample Type | Assay utilizes human serum or urine as test samples | Assay utilizes human serum or urine as test samples |
| Analysis Technology | Utilizes chemiluminescent technology for quantitation with assay incubated to 37°C. | Utilizes chemiluminescent technology for quantitation with assay incubated to 37°C. |
| Sensitivity | Sensitivity & critical detection limit sufficient to utilizes human serum or urine for hCG isoforms in determination of pregnancy | Sensitivity & critical detection limit sufficient to utilizes human serum or urine for hCG isoforms in determination of pregnancy |
| Interferences - serum | High limits for interference from serum a) protein, b) bilirubin, c) triglycerides, and d) free serum hemoglobin | High limits for interference from serum a) protein, b) bilirubin, c) triglycerides, and d) free serum hemoglobin |
| Interferences - urine | High limits for interference from urine glucose via severe diabetes | High limits for interference from urine glucose via severe diabetes |
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| Differences | ||
|---|---|---|
| Feature | Nichols Advantage | |
| H-hCG New Assay* | DPC IMMULITE 2000 hCG | |
| Predicate Immunoassay | ||
| Antibody | ||
| Recognition | Monoclonal antibodies that | |
| recognize H-hCG* | Monoclonal antibodies that | |
| recognize hCG | ||
| Sample Volume | 15 microliters | 5 microliters |
| Reporting Unit | ng/ml* [for H-hCG, based on | |
| Mass units of ng per ml serum] | mIU/ml [for hCG, based | |
| on milli-International Units] |
- The Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay reports values in ng/ml. The correlation for the reporting units of the predicate device compared to NID is expressed by Y(DPC's) = -5.36 + 28.32X(NID's) with correlation factor r=0.935, P-Value 1.0 ng/ml) determined by the conversion of DPC's international units from mIU/ml to the NID's units of ng H-hCG/ml serum, the relative sensitivity between the Nichols Advantage H-hCG assay with the DPC predicate device was 100.0% in serum and 99.0% in urine.
| METHOD COMPARISON (SERUM)
DPC vs. NID | | | | METHOD COMPARISON (URINE)
DPC vs. NID | | | |
|------------------------------------------|----------|----------|--------|------------------------------------------|----------|----------|--------|
| 'n =659 | | | | 'n =777 | | | |
| DPC | | | | DPC | | | |
| NID | Positive | Negative | Total | NID | Positive | Negative | Total |
| Positive | 473 | 6 | 479 | Positive | 616 | 16 | 632 |
| Negative | 0 | 180 | 180 | Negative | 6 | 139 | 145 |
| Total | 473 | 186 | 659 | Total | 622 | 155 | 777 |
| 95% CI | | | | | | | 95% CI |
| Concordance | 99.1% | 98.4% | -100% | Concordance | 97.2% | 97.93% | -98.4% |
| Percentage agreement
positive | 100.0% | 99.1% | -100% | Percentage agreement
positive | 99.0% | 97.9% | -99.6% |
| Percentage Agreement
negative | 96.8% | 93.4% | -98.6% | Percentage Agreement
negative | 89.6% | 83.9% | -93.6% |
6
Note: For n = 61 data pairs (from 357) with specific gestation equal or less than 2 weeks, results by both methods gave correlation readings of: Y/DPC] = - 5.36 + 28.32 X/NID/ and showed correlation value of r= 0.935, & P-Value 0-2 | 2-4 | 37 | 2.9 | 2.7-13.3 |
| 2-3 | 4-5 | 55 | 14.5 | 11.8-28.9 |
| 3-4 | 5-6 | 90 | 73.6 | 57.4-149.5 |
| 4-5 | 6-7 | 73 | 230.1 | 114.6-435.8 |
| 5-6 | 7-8 | 47 | 490.1 | 369.8-650.4 |
| 6-7 | 8-9 | 31 | 585.0 | 514.9-1054.3 |
| 7-12 | 9-14 | 24 | 101.7 | 42.2-297.9 |
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12.8.3.c. PARALLELISM
Samples with varying concentrations of H-hCG were either manually diluted with Sample Diluent before placing onto the system, or diluted on-board the system. The results demonstrate linearity across the dynamic range of this Nichols Advantage H-hCG immunochemiluminescent assay.
| Serum No. | Dilution | Observed (ng/mL) | Expected (ng/mL) | % Recovery |
|---|---|---|---|---|
| 1 | Undiluted | 12.2 | ||
| 1 | 1:2 | 6.7 | 6.1 | 110 |
| 1 | 1:4 | 3.3 | 3.1 | 106 |
| 2 | Undiluted | 70.1 | ||
| 2 | 1:2 | 35.2 | 35.1 | 100 |
| 2 | 1:4 | 19.1 | 17.5 | 109 |
| 2 | 1:8 | 9.0 | 8.8 | 102 |
| 3 | Undiluted | 135.6 | ||
| 3 | 1:2 | 69.5 | 67.8 | 103 |
| 3 | 1:4 | 37.1 | 33.9 | 109 |
| 3 | 1:8 | 19.6 | 17.0 | 115 |
12.8.3.d. RECOVERY
Three sets of a high and a low/normal serum samples were mixed in 2:1, 1:1 and 1:2 ratios and assayed. The recoveries were determined from the undiluted results. The results demonstrate recovery of H-hCG in patients' samples between 89 and 110%.
| Serum Sample | Observed(ng/mL) | Expected(ng/mL) | % Recovery |
|---|---|---|---|
| Sample A | 135.6 | ||
| 2 : 1 | 86.6 | 97.0 | 89 |
| 1 : 1 | 75.2 | 77.7 | 97 |
| 1 : 2 | 55.6 | 58.4 | 95 |
| Sample B | 19.8 | ||
| Sample C | 154.4 | ||
| 2 : 1 | 103.0 | 106.5 | 97 |
| 1 : 1 | 74.1 | 82.6 | 90 |
| 1 : 2 | 55.7 | 58.6 | 95 |
| Sample D | 10.7 | ||
| Sample E | 82.9 | ||
| 2 : 1 | 60.2 | 59.1 | 102 |
| 1 : 1 | 44.8 | 47.3 | 95 |
| 1 : 2 | 33.9 | 35.4 | 96 |
| Sample F | 11.6 |
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12.9. Performance Characteristics - Summary
| FEATURE | DPC IMMULITE hCG
Immunoassay* | Nichols Advantage H-hCG
Assay* |
|--------------------------|--------------------------------------------------------------|---------------------------------------------------------------|
| Within-Run | Not greater than 7% at dose greater than
6.5 mIU/mL Serum | Not greater than 5% at a dose greater than
10 ng/mL Serum |
| Total | Not greater than 8% at dose greater than
6.5 mIU/mL Serum | Not greater than 10% at a dose greater than
10 ng/mL Serum |
| Recovery | 100% - 112% | 89% - 110% |
| Parallelism | 91% to 98% | 86% - 115% |
| High Dose
Hook Effect | None up to 2,000,000 mIU/mL | None up to 31,000 ng/mL |
| Cross-
Reactivity | DPC IMMULITE hCG
Immunoassay* | Nichols Advantage H-hCG Assay* |
| Cross-
Reactant | Quantity Spiked
(ng/mL)
Cross-Reactivity | Quantity Spiked
(ng/mL)
Cross-Reactivity |
| FSH | 26.8
ND | 10000
0.0% |
| LH | 16.5
ND | 10000
0.1% |
| TSH | 860
ND | 10000
0.0% |
Table of Methods Comparisons - for Recovery, Hook Dose & Cross-Reactivity*
- Table 22a shows the performance characteristics in parallel between DPC and NID assays where DPC's readings were in mIU/ml and NID readings were in ng/ml except cross reactivity results in ng/ml as substances were spiked.
** FSH Unit/Mass conversion factor: LH Unit/Mass conversion factor: TSH Unit/Mass conversion factor:
2735 IU/mg 10,000 IU/mg 6.5 IU/mg
Table of Methods Comparisons -
for Both Serum & Urine re: Positives & Negatives **
| Method Comparison** | |
|---|---|
| Serum Sample Size: | 659 (pregnant and non pregnant) |
| Range of Results: | DPC IMMULITE hCG Immunoassy: Trade/Device Name: Nichols Advantage® Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: DHA, JIT, JJX Dated: October 22, 2004 Received: October 26, 2004 |
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 (QS) regulation (21 CFR Part 820).
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Page 2 -
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,
Sincerely yours,
Cornelia B. Parks
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
13
INDICATIONS FOR USE
K042676 510(k) Number:
Device Name:
Nichols Advantage® Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay
Indications For Use Statement: The Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay (or simply: Nichols Advantage® H-hCG Assay) is intended for use with the Nichols Advantage Specialty System for the quantitative measurement of hyperglycosylated human chorionic gonadotropin (H-hCG), a placental hormone in human serum, or for the qualitative determination of H-hCG in urine as an aid in the detection of pregnancy. These diagnoses should be made with appropriate additional clinical evidence. Clinical considerations and professional judgment should be applied to any test device result as with this Nichols H-hCG chemiluminescent immunoassay.
The Nichols Advantage® H-hCG Assay is used in conjunction with two H-hCG calibrators which are used to calibrate the assay and are provided separately to the reagent cartridge. The control is used for the monitoring of the accuracy and precision of the Nichols Advantage H-hCG Assay and successful calibration is confirmed using three H-hCG controls also provided separately to the calibrators and reagent cartridge,
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter use _________________________________________________________________________________________________________________________________________________________
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices.(OIDE)
Carol C. Benson
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