The A/C Portable Enzymatic Homocysteine Assay on the A/C Diagnostics Reader (HyTek-205) is intended for the quantitative determination of total homocysteine (tHCY) in human plasma or serum. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia. The A/C Enzymatic Homocysteine Assay is for in vitro diagnostic use.

Device Description

The A/C Portable Enzymatic Homocysteine Assay is calibrated with A/C Enzymatic Homocysteine Assay Calibrators. A/C Enzymatic Homocysteine Assay Controls are assayed for the verification of the accuracy and precision of the A/C Portable Enzymatic Homocysteine Assay.

The A/C Enzymatic Homocysteine Assay measures tHCY. The principle of the assay is that after reduction, tHCY is depleted by Homocysteinase (rHCYase) and produces hydrogen sulfide (H2S), which is determined using N.N-dibutyl phenylene diamine (DBPDA), the combination of which forms a chromophore, the fluorescence is measured by the A/C Diagnostics Reader (HyTek-205).

The A/C Portable Enzymatic Homocysteine Assay is a three-steps reaction, which runs at room temperature. The total assay takes 80 minutes, and the A/C Diagnostics Reader is the only equipment needed.

AI/ML Overview

Here's an analysis of the provided text regarding the A/C Portable Enzymatic Homocysteine Assay, focusing on acceptance criteria and the supporting study:

The provided document is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. It focuses on demonstrating that the new device performs as well as, or better than, the predicate. Therefore, the "acceptance criteria" are implicitly established by the performance of the predicate device. The study aims to show that the new device's performance aligns closely with that of the predicate.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds in this summary. Instead, they are implied by the reported performance of the predicate device, which the new device aims to match or closely approximate. The primary performance metric for comparison is the correlation and mean difference between the new device and the predicate.

Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (A/C Portable Enzymatic Homocysteine Assay)
Correlation with Predicate Device (A/C Automatic Enzymatic HCY Assay on Hitachi 912): High correlation expected, aiming for a regression line close to y=x and a correlation coefficient (R) close to 1.	Correlation and Regression: y = 1.01x + 0.91, with a correlation coefficient of R = 0.95. This indicates a strong positive linear relationship and close agreement with the predicate device.
Mean Difference from Predicate Device: A small mean difference, ideally close to 0, indicating minimal systematic bias between the two assays. Evaluation via Bland-Altman plot to ensure agreement across the assay range, with samples at both low and high concentrations agreeing well.	Mean Difference: The mean difference between the two assays was 1.05 umol/L. The document states that "The samples both at low and high concentrations of tHCY agreed well," suggesting acceptable agreement across the measuring range.
Within-Assay Coefficient of Variation (CV): Expected to be within a similar range as the predicate (3.0% to 4.8%).	Within-Assay CV: Ranged from 3.8% to 4.8%. This falls within the reported range of the predicate device (3.0% to 4.8%), indicating comparable precision.
Between-Assay Coefficient of Variation (CV): Expected to be within a similar range as the predicate (4.9% to 7.8%).	Between-Assay CV: Ranged from 5.0% to 7.4%. This also falls within the reported range of the predicate device (4.9% to 7.8%), indicating comparable precision.
Intended Use: The device must quantitatively determine total homocysteine (tHCY) in human plasma or serum and assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia, for in vitro diagnostic use. This is a functional requirement, and the device's design and mechanism must support this.	Intended Use: The device description and "Indications for Use" section explicitly state: "The A/C Portable Enzymatic Homocysteine Assay on the A/C Diagnostics Reader (HyTek-205) is intended for the quantitative determination of total homocysteine (tHCY) in human plasma or serum. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia. The A/C Enzymatic Homocysteine Assay is for in vitro diagnostic use."

Study Details

Sample Size used for the test set and the data provenance:
- Sample Size: 50 plasma samples.
- Data Provenance: Not explicitly stated regarding country of origin or specific demographics. The samples are referred to as "fifty plasma samples," implying they were clinical samples. The study is retrospective, as it compares the new device's results on these samples against those obtained from an existing, already cleared predicate device (the A/C Automatic Enzymatic HCY Assay on Hitachi 912).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to this type of device and study. The "ground truth" for a quantitative assay like this is typically established by comparison to a reference method or a substantially equivalent predicate device, not by expert consensus on qualitative interpretation. The predicate device itself (A/C Automatic Enzymatic HCY Assay on Hitachi 912) served as the reference for comparison.
Adjudication method for the test set:
- Not applicable. This is a quantitative assay comparison, not a diagnostic imaging or expert interpretation study requiring adjudication.
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:
- No MRMC study was done. This is a comparison of two in vitro diagnostic devices, not an AI-assisted diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is partially applicable, as the "A/C Portable Enzymatic Homocysteine Assay on the A/C Diagnostics Reader" is a standalone system in the sense that it performs the measurement without human subjective interpretation of results, beyond the operator running the test. The study is comparing the performance of this standalone system against another standalone system (the predicate device). The performance metrics (correlation, regression, mean difference, precision) are all "algorithm only" or "device only" metrics.
The type of ground truth used:
- The "ground truth" for this study was the results obtained from the predicate device, the A/C Automatic Enzymatic HCY Assay on Hitachi 912 (K030754). This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices.
The sample size for the training set:
- The document does not explicitly mention a "training set" in the context of device development or machine learning. For in vitro diagnostic assays, performance characteristics are typically established through analytical studies (e.g., precision, linearity, interference) and clinical comparison studies (like this one) using patient samples, rather than a machine learning training paradigm.
How the ground truth for the training set was established:
- Not applicable, as a "training set" in the machine learning sense is not described. The predicate device's performance was already established through its prior 510(k) clearance (K030754).

Summary

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510(k) SUMMARY

The A/C Portable Enzymatic Homocysteine Assay on the A/C Diagnostics Reader

Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

1. Submitter Information

Submitter: AntiCancer Inc. 7917 Ostrow Str. San Diego, California 92111 Phone: (858)654-2555 FAX: (858)268-4175 e-mail: (1) (2) (2) unticunder com

Yuying Tan, M.D. Contact Person: Principal Investigator of the Device Research Manager of AntiCancer Inc.

Date of Summary Preparation: March 24, 2008 Revised: Sep 16, 2008

2. Device Information

510K:#: K080851 Device Name: A/C Portable Enzymatic Homocysteine Assay Classification Name: Homocysteine Assay Class: II Product Code: LPS

3. Predicate Device Information

Device Name: A/C Enzymatic Homocysteine Assay on Hitachi 912 AntiCancer Inc. 7917 Ostrow Str. San Diego, California 92111 Phone: (858)654-2555 FAX: (858)268-4175 e-mail: http://www.bases.n 510(k) Number: K030754

Tan Y/510k/HCY Assay /510 k Summary (9/16/2008)

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Information of Manufacturers 4.

Kit Manufacturer

Contract Manufacturer:	Bioserv Corporation5340 Eastgate MallSan Diego, CA 92121Telephone: (858) 450-3123FAX: (858) 450-0785
FDA Establishment Registration Number:	US FDA 2027352
Contact Person :	Mary RichardsonQuality Assurance Manager

Reader Manufacturer

Contract Manufacturer:	Wuxi Opulen Technologies Ltd.
	3-405, Originality Industrial Park
	Liyuan Economic Zone
	Wuxi, Jiangsu, 214072
	P.R. China
	Telephone: (86) 510-85160567
	FAX: (86) 510-85160369
	Establishment Registration Number: 04707Q10000268, P.R. China

Contact Person :

Jiasen Yan President

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ર. Statement of Intended Use

The A/C Portable Enzymatic Homocysteine Assay on the A/C Diagnostics Reader (HyTek-205) is intended for the quantitative determination of total homocysteine (tHCY) in human plasma or serum. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia. The AiC Enzymatic Homocysteine Assay is for in vitro diagnostic use.

Description of Device 6.

The A/C Portable Enzymatic Homocysteine Assay is a three-steps reaction, which runs at room temperature. The total assay takes 80 minutes, and the A/C Diagnostics Reader is the only equipment needed.

7. Method Comparison

To establish equivalence to an existing device, and thus establish the safety and effectiveness. The A/C Portable Homocysteine Enzymatic Assay (K080851) on the A/C Diagnostics Reader is compared to the Predicate Device, the A/C Automatic Enzymatic HCY Assay on Hitachi 912 (K030754) {Table 1}.

The comparison of the A/C Portable Homocysteine Assay on the A/C Diagnostics Reader to the A/C Automatic Homocysteine Assay on the Hitachi 912 Automatic Analyzer [4-5] was carried for fifty plasma samples. The correlation and regression analysis yielded y = 1.01+0.91 with a correlation coefficient of R = 0.95. The distribution of the difference vs mean of paired tHCY values were shown in Bland-Altman plot. The mean difference between the two assays was 1.05 umol/L. The samples both at low and high concentrations of tHCY agreed well.

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Table 1. Comparison of the A/C Portable Enzymatic HCY Assay and the A/C Automatic Enzymatic HCY Assay

A/C EnzymaticHCY Assay		Differences
		K 080851Portable HCY Assay	K 030754Automatic HCY Assay
Similarities	Principle	Enzymatic
	Indication for Use	The A/C Enzymatic Assay is intended for the quantitativedetermination of total homocysteine (tHCY) in humanplasma or serum. The device can assist in the diagnosisand treatment of patients suspected of havinghyperhomocysteinemia.The assay is for in vitro diagnostic use.
	Precision	CV for within assay rangedfrom 3.8% to 4.8%.CV for between assayranged from 5.0% to 7.4%.	CV for within assay rangedfrom 3.0% to 4.8%.CV for between assayranged from 4.9% to 7.8%.
Differences	Performance	PortableManual	FullyAutomatic
	Equipment	A/C Diagnostics Reader	Hitachi 912 AutomaticAnalyzer
	Application	Small Lab	Large Lab andBig Hospital
	Highthroughput	100 tests/hr	360 tests/hr

K. 080851 Portable Assay: A/C Portable Enzymatic HCY Assay is the assay for current . 510k application.
K 030754 Automatic Assay: A/C Automatic Enzymatic HCY Assay is the predicate . device, which 510k application has been cleared by FDA in 2003.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 0 2008

AntiCancer, Inc. c/o Yuying Tan, M.D. Research Manager 7917 Ostrow Road San Diego, CA 92111

Re: K080851 Trade Name: A/C Portable Enzymatic Homocysteine Assay on the A/C Diagnostics Reader Regulation Number: 21 CFR 862.1377 Regulation Name: Urinary Homocysteine Test System Regulatory Class: Class II Product Codes: LPS Dated: September 16, 2008 Received: September 25, 2008

Dear Dr. Tan:

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. Insting 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 (240) 276-0490. Also, please not 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 tolli the (800) 638-2041 or (240) 276-3150 or at its Internet address str http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

14080851 510(k) Number (if known):

Device Name:

Indications For Use:

ー

Prescription Use __ *_ AND/OR (Part 21 CFR 801 Subpart D)

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 (OIVD)
Divisic
Off of In Vitro Diagnostic Device
Evaluation and Safety
Tan Y/510k/Hcy Assay/Indications for Use (8/14/2008)

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Regulation Number and Section

§ 862.1377 Urinary homocystine (nonquantitative) test system.

(a)
Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.(b)
Classification. Class II.