(198 days)
No
The summary describes a standard enzymatic assay and reader, with no mention of AI/ML in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic (IVD) device used for quantitative determination of homocysteine levels, not for providing therapy.
Yes
The "Intended Use / Indications for Use" section states: "The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia." This directly indicates its diagnostic purpose.
No
The device description explicitly mentions the "A/C Diagnostics Reader (HyTek-205)" as the only equipment needed and describes a chemical reaction with fluorescence measurement, indicating a hardware component is essential for the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The A/C Enzymatic Homocysteine Assay is for in vitro diagnostic use."
- Intended Use: The device is intended for the "quantitative determination of total homocysteine (tHCY) in human plasma or serum." This involves testing biological samples outside of the body to provide information for diagnosis and treatment.
- Assisting in Diagnosis and Treatment: The intended use also states the device "can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia." This is a key characteristic of IVD devices.
- Device Description: The description details an enzymatic assay that measures a substance (tHCY) in a biological sample (plasma or serum) using a specific chemical reaction and detection method. This is typical of an in vitro diagnostic test.
N/A
Intended Use / Indications for 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 A/C Enzymatic Homocysteine Assay is for in vitro diagnostic use.
Product codes
LPS
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.
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
Not Found
Intended User / Care Setting
Not Found
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)
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).
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficient of R = 0.95.
Mean difference between the two assays was 1.05 umol/L.
Precision:
CV for within assay ranged from 3.8% to 4.8%.
CV for between assay ranged from 5.0% to 7.4%.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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)
1
Information of Manufacturers 4.
Kit Manufacturer
| Contract Manufacturer: | Bioserv Corporation
5340 Eastgate Mall
San Diego, CA 92121
Telephone: (858) 450-3123
FAX: (858) 450-0785 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| FDA Establishment Registration Number: | US FDA 2027352 |
| Contact Person : | Mary Richardson
Quality 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
2
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 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.
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.
3
Table 1. Comparison of the A/C Portable Enzymatic HCY Assay and the A/C Automatic Enzymatic HCY Assay
| A/C Enzymatic
| HCY Assay | Differences | ||
|---|---|---|---|
| K 080851 | |||
| Portable HCY Assay | K 030754 | ||
| Automatic HCY Assay | |||
| Similarities | Principle | Enzymatic | |
| Indication for Use | The A/C Enzymatic Assay 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 assay is for in vitro diagnostic use. | |||
| Precision | CV for within assay ranged | ||
| from 3.8% to 4.8%. | |||
| CV for between assay | |||
| ranged from 5.0% to 7.4%. | CV for within assay ranged | ||
| from 3.0% to 4.8%. | |||
| CV for between assay | |||
| ranged from 4.9% to 7.8%. | |||
| Differences | Performance | Portable | |
| Manual | Fully | ||
| Automatic | |||
| Equipment | A/C Diagnostics Reader | Hitachi 912 Automatic | |
| Analyzer | |||
| Application | Small Lab | Large Lab and | |
| Big Hospital | |||
| High | |||
| throughput | 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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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
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.
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) |
| Page 1 of | 1 |
|---|---|
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