The Quantech Total β-hCG Assay is intended to be used, as aid in the early detection of pregnancy.
The Quantech Total β-hCG Assay is intended to be used for the quantitative determination of human chorionic gonadotropin in EDTA-stabilized plasma, for the early detection of pregnancy.

Device Description

The Quantech Total ß-hCG assay is based on the principle of two site, or sandwich immunoassay in combination with surface plasmon resonance (SPR) surface mass measurement. Each test module contains a solid phase anti-ß-hCG monoclonal antibody immobilized onto a gold surface. An anti-hCG polyclonal antibody, used to enhance the specific detection by SPR is introduced sequentially.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the Quantech Total β-hCG Assay based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit, numerical acceptance criteria for each performance metric. However, we can infer the implied acceptance criteria based on the comparison to the predicate and general expectations for in vitro diagnostic devices.

Performance Metric	Acceptance Criteria (Inferred)	Reported Device Performance
Dilution Linearity/Parallelism	Percent of expected should be close to 100% (indicating linearity and accuracy across dilutions).	The average percent of expected was 101%.
Recovery	Percent recovery of added analyte should be close to 100% (indicating accurate measurement of known concentrations).	After correcting for endogenous β-hCG content, the average recovery was 104%.
Analytical Sensitivity	Detectable minimum quantity of β-hCG should be sufficiently low for early pregnancy detection and comparable to predicate.	The calculated analytical sensitivity is 8.8 mIU/mL.
Precision (INTRAASSAY)	Coefficient of Variation (% C.V.) should be within acceptable limits for a quantitative assay, generally lower for higher concentrations.	For 38.7 mIU/mL: 15.8% C.V.For 132 mIU/mL: 12.8% C.V.For 617 mIU/mL: 4.5% C.V.
Precision (INTERASSAY)	Coefficient of Variation (% C.V.) should be within acceptable limits, demonstrating reproducibility over time.	For 41.3 mIU/mL: 13.0% C.V.For 156 mIU/mL: 11.4% C.V.For 746 mIU/mL: 7.0% C.V.
Total Imprecision	Overall variability (% C.V.) across multiple runs and days should be acceptable.	For 41.3 mIU/mL: 18.5% C.V.For 156 mIU/mL: 14.8% C.V.For 746 mIU/mL: 9.4% C.V.
Interfering Substances	No significant interference from common physiological substances. Percent recovery should be acceptable.	Percent recovery of β-hCG was determined to be acceptable in all three solutions (hemoglobin, bilirubin, triglycerides) based on overlapping expected ranges. No interference noted.
Hook Effect	No erroneous low results for greatly elevated samples.	No high dose hook effect was observed up to at least 100,000 mIU/mL.
Normal Range	Performance similar to predicate at/below 25 mIU/mL cut-off. No false positives in healthy non-pregnant individuals. Agreement with published expected values.	Performs similarly to predicate. Mean of normals below detection limit of both assays. No false positive results. 100% agreement with predicate device in healthy, non-pregnant individuals.
Patient Sample Correlation	High correlation coefficient with a commercially available method (predicate or similar standard). Results linearly related over a broad range.	Correlation coefficient of 0.98 (slope = 0.86, y-intercept = 7.2 mIU/mL) when compared to a commercially available fluorogenic ELISA.
Substantial Equivalence	Demonstrated essential equivalence to the predicate device (Abbott AxSYM® Total β-hCG assay) in technological characteristics and performance.	"The Quantech Total ß-hCG Assay provides results which are internally accurate, unaffected by ordinary variation of sample matrix and equivalent to the results obtained using the approved device in a valid laboratory setting." "Both clinically-based studies... demonstrated essential equivalence between the two devices..."

2. Sample Sizes Used for the Test Set and Data Provenance

Dilution Linearity/Parallelism: Plasma samples "separately spiked with hCG and serially diluted" - specific number of samples not given.
Recovery: Not specified, but involved "test results as the percentage of added analyte."
Analytical Sensitivity: "Multiple replicates of zero samples (male plasma)" - specific number not given.
Precision (INTRAASSAY): Three pools, 10 different biosensors.
Precision (INTERASSAY): Three pools, tested in triplicate on different days - specific number of days not given.
Interfering Substances: A plasma pool of hCG spiked with 3 different substances (hemoglobin, bilirubin, triglycerides).
Hook Effect: "Samples well beyond the standard curve range" - specific number not given.
Normal Range: "Apparently healthy, non-pregnant individuals" - specific number not given.
Patient Sample Correlation: "Human samples with values distributed throughout the quantitative range of the Quantech Total β-hCG Assay" - specific number not given.

Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the context of a 510(k) submission, the data would typically be generated by the manufacturer for the purpose of the submission, likely in a controlled laboratory setting. Clinical samples are typically prospective, but the document does not confirm this.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This type of in vitro diagnostic device (an immunoassay) does not typically rely on human expert interpretation for establishing ground truth in the same way an imaging AI device would. The "ground truth" for the test set is established through:

Known concentrations: For linearity, recovery, analytical sensitivity, precision, and hook effect, the ground truth is the precisely known concentration of hCG in spiked samples or reference materials.
Clinical status (pregnancy/non-pregnancy): For the normal range study, the ground truth is the clinically determined non-pregnant status of individuals.
Predicate device results: For validation and comparison, the results from the legally marketed predicate device (AxSYM® Total β-hCG assay) or another commercially available method (fluorogenic ELISA) serve as the comparative ground truth.

Therefore, the concept of "experts" to establish ground truth in the traditional sense of medical image interpretation is not directly applicable here. The accuracy of measurements relies on established biochemical and analytical methods.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth for this type of assay is objective measurement or clinical status, not subjective interpretation requiring adjudication of expert opinions.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic device (an immunoassay), not an AI-powered diagnostic system that assists human readers/interpreters. There is no human-in-the-loop component for reading assay results in the context of diagnostic interpretation that would warrant an MRMC study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, implicitly. The performance data presented (linearity, recovery, sensitivity, precision, interference, hook effect, normal range, patient correlation) reflects the standalone performance of the Quantech Total β-hCG Assay itself, without human intervention in the result generation or initial interpretation. The device's output is a quantitative value of β-hCG concentration.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for this device is a combination of:

Reference standard concentrations: For analytical performance metrics like linearity, recovery, sensitivity, precision, interference, and hook effect, the ground truth is established by precisely prepared samples with known concentrations of hCG.
Clinical status: For the normal range study, the ground truth is the confirmed non-pregnant status of the individuals.
Predicate device performance/established clinical methods: For comparison and validation (patient sample correlation, normal range comparison), the results obtained from a legally marketed device (AxSYM® Total β-hCG assay) or another "commercially available method (fluorogenic ELISA)" serve as the established reference or comparative ground truth.

8. The Sample Size for the Training Set

Not applicable. This document describes a traditional immunoassay, not a machine learning or AI-based device that requires a "training set." The device is built on established biochemical principles and analytical methods, not learned from data in a training phase.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" for this type of device.

Summary

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510(k) SUMMARY

Contact Information

Robin J. Hellen, M.S. Hellen Professional Services (818) 709-5646

Product Name

Classification Name:	Human Chorionic Gonadotropin (hCG) Test Systems, Class II
Trade Name:	Quantech Total β-hCG Assay
Common Name:	β-hCG Test Kit

CLIA Categorization

We believe the Quantech Total ß-hCG Assay to be moderately categorized based on previous classification of analogous tests.

Substantial Equivalence

The Quantech Total ß-CG Assay is substantially equivalent to the AxSYM® Total ß-hCG assay marketed by Abbott Laboratories since 1998.

Intended Use

The Quantech Total β-hCG Assay is intended to be used, as aid in the early detection of pregnancy.

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Device Description

Comparison of Technological Characteristics

The Quantech Total ß-hCG Assay is similar to the AxSYM® Total ß-hCG assay as follows. Both assays are in vitro "sandwich" immunometric assays for the quantitative measurement of total ß-hCG. Additionally, both assays use antibody to ß-hCG coated on a solid support, and both instruments utilize a microprocessor for instrument control, data acquisition, and data reduction.

Summary of Non-Clinical Performance Data

Dilution Linearity/Parallelism - The parallelism study was conducted to evaluate the linearity of the Quantech Total ß-hCG Assay. Plasma samples were separately spiked with hCG and serially diluted with corresponding unspiked serum. The average percent of expected was 101%.

Recovery - Accuracy of the Quantech Total ß-hCG Assay was calculated from test results as the percentage of added analyte, corrected for endogenous analyte, recovered by the assay. After correcting for endogenous ß-hCG content, the average recovery was 104%.

Analytical Sensitivity - Multiple replicates of zero samples (male plasma) were assayed to determine the minimum quantity of ß-hCG detectable by the Quantech Assay. The average SPR signal shift plus two standard deviations (2 S.D.) was calculated and translated into a dose. The calculated analytical sensitivity of the Quantech Total β-hCG assay is 8.8 mlU/mL.

Precision - The INTRAASSAY precision was determined by evaluating three pools using 10 different biosensors in one day. The mean B-hCG concentrations (with % C. V.) were 38.7 (15.8%), 132 (12.8%), and 617 (4.5%) mlUmL for the low, medium and high pools, respectively.

The INTERASSAY precision was determined by evaluating three pools in triplicate on different days. The mean B-hCG concentrations (with % C.V.) were 41.3 (13.0%), 156 (11.4%), and 746 (7.0%) mIU/mL for the low, medium and high pools, respectively.

TOTAL IMPRECISION was determined from the interassay data, and is a combination of results from multiple runs on multiple days. The mean ß-hCG concentrations (with % C.V.) were 41.3 (18.5%), 156 (14.8%), and 746 (9.4%) mlU/mL for the low, medium and high pools, respectively.

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Summary of Non-Clinical Performance Data (Cont.)

Interfering Substances - Physiological interference was evaluated by spiking a plasma pool of hCG with hemoglobin, bilirubin and triglycerides at least ten times the highest expected physiological concentration. The percent recovery of β-hCG was determined to be acceptable in all three solutions based on the overlapping expected ranges before and affer spiking and no interference was noted by the endogenous substances in the Quantech Total 8-hCG Assay.

Hook Effect - Samples well beyond the standard curve range were assayed. No high dose hook effect was observed. Therefore, the Quantech Total B-hCG Assay does not give erroneously low results for greatly elevated samples up to at least 100,000 miU/mL.

Summary of Clinical Performance Data

Normal Range - Testing of apparently healthy, non-pregnant individuals demonstrated that the Quantech Total 3-hCG Assay and the predicate device perform similarly at and below the clinically accepted cut-off of 25 mlU/mL hCG. Both methods are also compatible with published expected values. The mean of the normals was below the detection limit of both assays.

The Quantech device demonstrates no false positive results with these apparently healthy individuals and is in 100% agreement with the predicate device.

Patient Sample Correlation - Results from human samples with values distributed throughout the quantitative range of the Quantech Total ß-hCG Assay, were compared with those obtained with a commercially available method (fluorogenic ELISA). The correlation coefficient was 0.98 (slope = 0.86, y-intercept = 7.2 mIU/mL).

Conclusions Drawn From Performance Tests

The Quantech Total ß-hCG Assay provides results which are internally accurate, unaffected by ordinary variation of sample matrix and equivalent to the results obtained using the approved device in a valid laboratory setting.

Additionally, both clinically-based studies (normal range, patient correlation) demonstrated essential equivalence between the two devices as measured by their correlation and the dearee to which assay results are linearly related to one another over a broad range of values. Likewise, the normal range evaluation provided empirical evidence that the assay value is similar for both devices, and in agreement with published data.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 1 1999

BioCheck, Inc. c/o Ms. Robin J. Hellen, M.S. Hellen Professional Services 9418 Lasaine Avenue Northridge, California 91325

Re: K990258

Trade Name: Quantech Total ß-hCG Assay Regulatory Class: II Product Code: NAL Dated: November 18, 1999 Received: November 19, 1999

Dear Ms. Hellen:

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 against 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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. Please note: this response to your premarket notification 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 regulations.

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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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

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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QUANTECH Total β-hCG ASSAY
Premarket Notification

RESPONSE A - Answers to FDA Questions

Statement for Indications for Use

510(k) Number (if known):	K990258
Device Name:	Quantech Total β-hCG Assay

Indications for Use:

The Quantech Total β-hCG Assay is intended to be used for the quantitative determination of human chorionic gonadotropin in EDTA-stabilized plasma, for the early detection of pregnancy.

Concurrence of the CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)	Dean Cooper
Division of Clinical Laboratory Devices
510(k) Number	K990258

Prescription Use:	OR	Over the Counter Use:

1 12 2 2012 20:00 10

K990258

Regulation Number and Section

§ 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.

Company Information

Contact Information

Product Name

CLIA Categorization

Substantial Equivalence

Intended Use

Device Description

Comparison of Technological Characteristics

Summary of Non-Clinical Performance Data

Summary of Non-Clinical Performance Data (Cont.)

Summary of Clinical Performance Data

Conclusions Drawn From Performance Tests

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§ 862.1155 Human chorionic gonadotropin (HCG) test system.