(448 days)
Not Found
No
The description details a biochemical assay based on enzymatic reactions and absorbance measurements, with no mention of AI or ML.
No.
The device is an in vitro diagnostic (IVD) assay designed to quantify vitamin B6 (PLP) in plasma for diagnosis of a deficiency. It does not treat or cure a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The A/C Enzymatic Vitamin B6 Assay is intended for the quantitative in vitro diagnostic determination... The device will be used to monitor PLP concentrations in plasma for aid in diagnosis of vitamin B6 deficiency. The A/C Enzymatic Vitamin B6 Assay is for IN VITRO DIAGNOSTIC USE ONLY." This directly indicates its role as a diagnostic device.
No
The device description clearly outlines a chemical assay involving reagents, enzymatic reactions, and measurement using a 96-well plate absorbance reader, indicating it is a hardware-based in vitro diagnostic device, not software only.
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 Vitamin B6 Assay is intended for the quantitative in vitro diagnostic determination of pyridoxal 5'-phosphate (PLP, vitamin Bo) in EDTAhuman plasma." and "The A/C Enzymatic Vitamin B6 Assay is for IN VITRO DIAGNOSTIC USE ONLY."
- Purpose: The device is used to measure a substance (PLP) in a biological sample (human plasma) to aid in the diagnosis of a medical condition (vitamin B6 deficiency). This is a core function of an IVD.
- Sample Type: It analyzes a sample taken from the human body (plasma).
- Setting: The intended user/care setting is explicitly stated as "IN VITRO DIAGNOSTIC USE ONLY," reinforcing its purpose in a laboratory or clinical setting for diagnostic testing.
The description of the assay method, reagents, and performance studies further supports its classification as an IVD, as these are typical components of a submission for an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The A/C Enzymatic Vitamin B6 Assay is intended for the quantitative in vitro diagnostic determination of pyridoxal 5'-phosphate (PLP, vitamin Bo) in EDTAhuman plasma. The device will be used to monitor PLP concentrations in plasma for aid in diagnosis of vitamin B6 deficiency. The A/C Enzymatic Vitamin B6 Assay is for IN VITRO DIAGNOSTIC USE ONLY.
INDICATION FOR USE STATEMENT:
- The A/C Enzymatic Vitamin B6 Assay is intended for the quantitative determination . of pyridoxal 5'-phosphate (PLP, vitamin Bo) in EDTA-plasma.
- The device will monitor vitamin Bo (PLP) status in human plasma for aid in diagnosis . of vitamin B6 deficiency.
- The A/C Enzymatic Vitamin B6 Assay is for IN VITRO DIAGNOSTIC USE . ONLY.
Product codes (comma separated list FDA assigned to the subject device)
JIT, JJX, CDD
Device Description
The A/C Enzymatic Vitamin B6 Assay is calibrated with external standardization and matrix-matched calibration solutions. Two sources of quality control material (A low and high level of PLP) are assaved in each run together with A/C Calibrators and samples for the verification of the accuracy and precision of the A/C Enzymatic Vitamin B6 Assay.
The A/C Enzymatic Vitamin B6 Assay uses the apo form of recombinant PLPdependent enzyme, homocysteine-a.y-lyase (rHCYase). The restoration of enzymatic activity by reconstitution of the holo-enzyme is linearly dependent on the amount of PLP bound to apo-enzyme. Nanomolar concentrations of PLP can then be measured by the conversion of millimolar concentrations of homocysteine to hydrogen sulfide, which is determined using DBPDA, the combination of which forms a chromophore, the absorbance is read with 96-well plate absorbance reader.
The A/C Enzymatic Vitamin B6 Assay is a three-step reaction with four reagents. which runs at 37°C or room temperature. The total assay takes 90 minutes. The assay can be performance on 96-well absorbance reader with 660-690m filter.
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)
To establish equivalence to an existing device, and thus establish the safety and effectiveness, the A/C Enzymatic Vitamin Bo Assay was compared to ALPCO Vitamin B6 REA method (K# 955561).
The comparison of the A/C Enzymatic Vitamin B6 Assay to the ALPCO Vitamin B6 REA assay was carried for fifty four EDTA-plasma samples. Each sample was analyzed in duplicate with both methods. The correlation and regression analysis yielded y = 0.969x + 7.6 with a correlation coefficient of r = 0.909. The bias analysis of both methods by the difference (A/C Enzymatic Bg – ALPCO Bg) vs PLPCO Bg REA is shown in the Difference plot. The range of values was 16.3 - 189.3 nmol/L (mean = 6.3) for the A/C Enzymatic Vitamin B6 Assay and 15.8 -185.8 mmol/l (mean = 68.7) for ALPCO Vitamin B& REA Assay. The average difference exhibited by A/C Enzymatic Vitamin B6 Assay and ALPCO B6 REA in this study was 2.42 nmol/L.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient of r = 0.909.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1810 Vitamin B
12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.
0
K III 260
510 (K) Summaries
JUL 26 2012
A/C Enzymatic Vitamin B6 Assay
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
- Submitter's Name:
Submitter: A/C DIAGNOSTICS LLC 7917 Ostrow Street San Diego, CA 92111 Phone: (858) 654-2555 Fax: (858) 268-4175 Email: all@anticancer.com
Contact Person:
Qinghong Han M.D. Principal Investigator of the Device
Date of Summary Preparation: March 15, 2011
-
- Device Information
Device Name: A/C Enzymatic Vitamin B6 Assay
- Device Information
Classification Panel: Clinical Chemistry
Device Classification: II
-
- Regulatory Information:
Product Code: JIT, Regulation Section: 21 CFR 862.1150- Calibrator
- Regulatory Information:
JJX, Regulation Section: 21 CFR 862.1660-Quality Control Material (Assayed and Unassay)
1
-
- Predicate Device Information
- (1) Predicate device name:
- BUHLMAA Vitamin B6 REA American Laboratory Products CO., LTD PO BOX 451 Windham, NH 03087 Tel: (603) 893-8914
- (2) Predicate 510(k) number K955561
-
Information of Manufacturer Manufacturer: Bioserv Corporation 5340 Eastgate Mall San Diego, CA 92121 Tel: (858) 450-3123 Fax: (858) 450-0785 FDA establishment registration number: US FDA 2027352 Contact Person: Mary Richardson Quality Assurance Manager
-
Statement of Intended Use
The A/C Enzymatic Vitamin B6 Assay is intended for the quantitative in vitro diagnostic determination of pyridoxal 5'-phosphate (PLP, vitamin Bo) in EDTAhuman plasma. The device will be used to monitor PLP concentrations in plasma for aid in diagnosis of vitamin B6 deficiency. The A/C Enzymatic Vitamin B6 Assay is for IN VITRO DIAGNOSTIC USE ONLY.
- Description of Device
The A/C Enzymatic Vitamin B6 Assay is calibrated with external standardization and matrix-matched calibration solutions. Two sources of quality control material (A low
2
and high level of PLP) are assaved in each run together with A/C Calibrators and samples for the verification of the accuracy and precision of the A/C Enzymatic Vitamin B6 Assay.
The A/C Enzymatic Vitamin B6 Assay uses the apo form of recombinant PLPdependent enzyme, homocysteine-a.y-lyase (rHCYase). The restoration of enzymatic activity by reconstitution of the holo-enzyme is linearly dependent on the amount of PLP bound to apo-enzyme. Nanomolar concentrations of PLP can then be measured by the conversion of millimolar concentrations of homocysteine to hydrogen sulfide, which is determined using DBPDA, the combination of which forms a chromophore, the absorbance is read with 96-well plate absorbance reader.
The A/C Enzymatic Vitamin B6 Assay is a three-step reaction with four reagents. which runs at 37°C or room temperature. The total assay takes 90 minutes. The assay can be performance on 96-well absorbance reader with 660-690m filter.
7. Method comparison
To establish equivalence to an existing device, and thus establish the safety and effectiveness, the A/C Enzymatic Vitamin Bo Assay was compared to ALPCO Vitamin B6 REA method (K# 955561).
The comparison of the A/C Enzymatic Vitamin B6 Assay to the ALPCO Vitamin B6 REA assay was carried for fifty four EDTA-plasma samples. Each sample was analyzed in duplicate with both methods. The correlation and regression analysis yielded y = 0.969x + 7.6 with a correlation coefficient of r = 0.909. The bias analysis of both methods by the difference (A/C Enzymatic Bg – ALPCO Bg) vs PLPCO Bg REA is shown in the Difference plot. The range of values was 16.3 - 189.3 nmol/L (mean = 6.3) for the A/C Enzymatic Vitamin B6 Assay and 15.8 -185.8 mmol/l (mean = 68.7) for ALPCO Vitamin B& REA Assay. The average difference exhibited by A/C Enzymatic Vitamin B6 Assay and ALPCO B6 REA in this study was 2.42 nmol/L.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three tail feathers, representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
AntiCancer. Inc c.o Dr. Oinghong Han 7917 Ostrow St. San Diego, CA 92111
JUL 26 2012
k11260 Re:
Trade Name: A/C Enzymatic Vitamin B6 Assay Regulation Number: 21 CFR §862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: Class II Product Codes: CDD Dated: July 2, 2012 Received: July 12, 2012
Dear Dr Han:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
4
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you dent operation an Noro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, oblease note the regulation entitled, "Misbranding by reference to premarket notification" (21 protess note are to garding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrio's (OSB's) Division of Postmarket Surveillance at (301) 01nee of Bur vinialio and 22dding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
CITY rar 805), preaso go to implement htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
You may obtain other general information on your responsibilities under the Act from the Tou may obtain other gefarers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
Countney H. Lias, Ph.D. Director
Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
510(k) Number (if known): K111260
Device Name: A/C ENZYMATIC VITAMIN B6 ASSAY
Indications for Use:
INDICATION FOR USE STATEMENT:
- The A/C Enzymatic Vitamin B6 Assay is intended for the quantitative determination . of pyridoxal 5'-phosphate (PLP, vitamin Bo) in EDTA-plasma.
- The device will monitor vitamin Bo (PLP) status in human plasma for aid in diagnosis . of vitamin B6 deficiency.
- The A/C Enzymatic Vitamin B6 Assay is for IN VITRO DIAGNOSTIC USE . ONLY.
AND/OR Over-The-Counter Use Prescription Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Rute Chuler
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) 1112-60
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