(123 days)
Not Found
No
The description details a standard enzymatic assay and its performance characteristics on an automated analyzer. There is no mention of AI or ML being used for data analysis, interpretation, or any other function.
No
Explanation: This device is an in vitro diagnostic assay used for quantitative determination of total homocysteine, assisting in diagnosis and treatment, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia" and "The A/C Enzymatic Homocysteine Assay Kit is only for in vitro diagnostic use."
No
The device is an in vitro diagnostic assay kit that utilizes chemical reagents and is run on a specific hardware analyzer (Hitachi 912). It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The A/C Enzymatic Homocysteine Assay Kit is only for in vitro diagnostic use."
- Intended Use: The intended use is for the "quantitative determination of total homocysteine (tHCY) in human plasma or serum." This involves testing biological samples outside of the body, which is the definition of in vitro.
- Diagnostic Purpose: The device is intended to "assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia." This clearly indicates a diagnostic purpose.
N/A
Intended Use / Indications for Use
- The A/C Enzymatic Homocysteine 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 A/C Enzymatic Homocysteine Assay Kit is only for in vitro diagnostic use.
Product codes
LPS
Device Description
The A/C Enzymatic Homocysteine Assay is calibrated with A/C Enzymatic Homocysteine Assay Calibrators. The A/C Enzymatic Homocysteine Assay is assayed for the verification of the accuracy and precision on the Hitachi 912 Automatic Analyzer.
The A/C Enzymatic Homocysteine Assay measures tHCY. The principle of the assay is that recombinant homocysteinase (rHCYase) produces hydrogen sulfide (H2S) from tHCY, which is quantified by use of N,N-dibutyl phenylene diamine (DBPDA), the combination of which forms a chromophore.
The A/C Enzymatic Homocysteine Assay on the Hitachi 912 Automatic Analyzer used four reagents, a number compatible with implementation on the Hitachi 912 Automatic Analyzer. We used 30 uL of EDTA plasma in a dithiothreitol (DTT) reduction reaction (1 mmol/L DTT, 0.2% Triton X-100 in 40 mmol/L sodium phosphate buffer [pH 8.3]) for 1.5 minutes to release bound homocysteine. The rHCYase reaction (0.05 mg/ml in 40 mmol/L sodium phosphate buffer [pH 8.3] with 20 umol/L pyridoxal 5-phosphate [PLP]) is then run for 3.5 minutes. The DBPDA chromophore (12.5 mmol/L DBPDA in 1.5 N H2SO4) is then added and 5 minutes later, an oxidant, potassium ferricyanide (5 mmol/L K3Fe(CN)6 in 10 mmol/L sodium phosphate buffer [pH 7.6]), is added. Five minutes after addition of oxidant, the end-points are read at absorbances of 700 and 660 nm. As the assay is based on an increase in absorbance over baseline, no blank without enzyme was used. The detection limit of the assay is 1.5 umol/L defined by quantification of a serial dilution of a plasma sample of tHCY diluted to 0.77 umol/L. The limit of quantification is defined as the lowest concentration measured having a CV
§ 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
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
Submitter Information 1.
A/C Diagnostics Division AntiCancer Inc. 7917 Ostrow Str. San Diego, California 92111 Phone: (858)654-2555 FAX: (858)268-4175 e-mail: all(@anticancer.com
Contact Person:
Submitter:
Yuying Tan, M.D. Research Manager AntiCancer Inc.
Date of Summary Preparation: February 18, 2003
2. Device Information
Device Name:
A/C Enzymatic Homocysteine Assay
Classification Name: Class: Product Code: Homocysteine Assay II LPS
3. Predicate Device Information
| Device Name: | Bio-Rad Homocysteine by HPLC
Bio-Rad Laboratories
Diagnostics Group
4000 Alfred Nobel Drive
Hercules, California 94547 |
| -------------- | ------------------------------------------------------------------------------------------------------------------------------------ |
|---|
510(k) Number: K993107
1
Information of Manufacturer 4.
| Manufacturer: |
|---|
| --------------- |
Bioserv Corporation 5340 Eastgate Mall San Diego, CA 92121 Telephone: (858) 450-3123 (858) 450-0785 FAX:
FDA establishment registration number: US FDA 2027352
Contact Person :
Mary Richardson Quality Assurance Manager Bioserv Corporation
న. Statement of Intended Use
- The A/C Enzymatic Homocysteine 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 A/C Enzymatic Homocysteine Assay Kit is only for in vitro diagnostic use. .
Description of Device 6.
The A/C Enzymatic Homocysteine Assay is calibrated with A/C Enzymatic Homocysteine Assay Calibrators. The A/C Enzymatic Homocysteine Assay is assayed for the verification of the accuracy and precision on the Hitachi 912 Automatic Analyzer.
The A/C Enzymatic Homocysteine Assay measures tHCY. The principle of the assay is that recombinant homocysteinase (rHCYase) produces hydrogen sulfide (H2S) from tHCY, which is quantified by use of N,N-dibutyl phenylene diamine (DBPDA), the combination of which forms a chromophore.
The A/C Enzymatic Homocysteine Assay on the Hitachi 912 Automatic Analyzer used four reagents, a number compatible with implementation on the Hitachi 912 Automatic Analyzer. We used 30 uL of EDTA plasma in a dithiothreitol (DTT) reduction reaction (1 mmol/L DTT, 0.2% Triton X-100 in 40 mmol/L sodium phosphate buffer [pH 8.3]) for 1.5 minutes to release bound homocysteine. The rHCYase reaction (0.05 mg/ml in 40 mmol/L sodium phosphate buffer [pH 8.3] with 20 umol/L pyridoxal 5-phosphate [PLP]) is then run for 3.5 minutes. The DBPDA chromophore (12.5 mmol/L DBPDA in 1.5 N H2SO4) is then added and 5 minutes later, an oxidant, potassium ferricyanide (5 mmol/L K3Fe(CN), in 10 mmol/L sodium phosphate
2
buffer [pH 7.6]), is added. Five minutes after addition of oxidant, the end-points are read at absorbances of 700 and 660 nm. As the assay is based on an increase in absorbance over baseline, no blank without enzyme was used. The detection limit of the assay is 1.5 umol/L defined by quantification of a serial dilution of a plasma sample of tHCY diluted to 0.77 umol/L. The limit of quantification is defined as the lowest concentration measured having a CV