(56 days)
No
The device description details a competitive immunoassay based on chemical reactions and binding principles, with no mention of AI/ML algorithms for data analysis or interpretation. The performance studies focus on standard analytical metrics like sensitivity, precision, and method comparison, not on AI/ML model performance.
No
The device is described as an "in vitro diagnostic use in the quantitative determination of vitamin B12 in serum" which means its function is to measure a substance (vitamin B12) in bodily fluids, not to directly treat or alleviate a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "In vitro diagnostic use in the quantitative determination of vitamin B12".
No
The device description clearly outlines a competitive immunoassay process involving reagents, paramagnetic particles, and a system (ADVIA Centaur System) for quantitative determination of vitamin B12. This involves physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The very first section explicitly states "In vitro diagnostic use in the quantitative determination of vitamin B12 in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur System." This directly indicates its intended use as an in vitro diagnostic device.
- Device Description: The description details how the assay works by analyzing patient samples (serum, plasma) outside of the body to measure a specific analyte (vitamin B12). This is the core function of an in vitro diagnostic.
- Performance Studies: The inclusion of performance studies like "Expected Results," "Sensitivity and Assay Reportable Range," "Serum Versus Plasma Method Comparison," and "Precision" are standard components of documentation for IVD devices, demonstrating their analytical performance.
- Predicate Device(s): The mention of "Current legally marketed device (ACS:180 and ADVIA Centaur VB12)" as predicate devices further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
N/A
Intended Use / Indications for Use
In vitro diagnostic use in the quantitative determination of vitamin B12 in serum. heparinized plasma, or EDTA plasma using the ADVIA Centaur System using the ACS:180® Automated Chemiluminescence Systems.
In vitro diagnostic use in the quantitative determination of vitamin B12 in serum, heparinized plasma, or EDTA plasma using the ADVIA® Centaur System.
Product codes
CDD
Device Description
The ACS:180 VB12 and ADVIA Centaur assays are competitive assays.
Vitamin B12, or cyanocobalamin, is a complex corrinoid compound containing four pyrrole rings that surround a single cobalt atom. Humans obtain vitamin B12 exclusively from animal dietary sources, such as meat, eggs, and milk. Vitamin B12 requires intrinsic factor, a protein secreted by the parietal cells in the gastric mucosa, for absorption. Vitamin B12 and intrinsic factor form a complex that attaches to receptors in the ileal mucosa, where proteins known as trans-cobalamins transport the vitamin B12 from the mucosal cells to the blood and tissues. Most vitamin B12 is stored in the liver as well as in the bone marrow and other tissues.
The ACS:180 VB12 and ADVIA Centaur VB12 assays are competitive assays in which vitamin B12 from the patient sample competes with vitamin B12 labeled with acridinium ester in the Lite Reagent, for a limited amount of purified intrinsic factor, which is covalently coupled to paramagnetic particles in the Solid Phase. The assay uses Releasing Agent (sodium hydroxide) and DTT to release the vitamin B12 from the endogenous binding proteins in the sample and cobinamide to prevent rebinding after the Solid Phase is added to the sample.
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
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Summary of Performance Studies
To determine the reference range for the ACS:180 and ADVIA Centaur VB12 assays, data was obtained on 298 serum samples, including 253 samples from apparently healthy individuals and 45 samples from physician-diagnosed vitamin B12 deficient patients. Ninety-five percent of the serumACS:180 VB12 values for the apparently healthy individuals fell in the range of 211 to 911 pg/mL (156 to 672 pmol/L).
The ACS:180 and ADVIA Centaur VB12 assays measures vitamin B12 concentrations up to 2000 pg/mL (1476 pmol/L) with a minimum detectable concentration of 30 pg/mL (22 pmol/L).
Serum Versus Plasma Method Comparison:
ACS 180: A comparison of values for 213 pairs of serum and plasma specimens in the range of 160 to 1000 pg/mL (118 to 738 pmol/L) yielded the following regression equation: plasma VB12 = 1.04 (serum VB12) + 9 pg/mL, r = 0.96
ADVIA Centaur: A comparison of values for 207 pairs of serum and plasma specimens in the range of 147 to 1033 pg/mL (108 to 762 pmol/L) yielded the following regression equation: plasma VB12 = 1.03 (serum VB12) + 12 pg/mL, r = 0.96
Precision:
ACS180: Four samples were assayed 3 times in 7 assays, on each of 11 systems (n=231 for each sample), over a period of 5 days.
ADVIA Centaur: Four samples were assayed 6 times, in each of 12 runs, on 6 systems, (n = 72 for each sample), over a period of 3 days.
Key Metrics
ACS180 Expected Results - Normal: Median (pg/mL): 382, Range (pg/mL): 211–911, Median (pmol/L): 282, Range (pmol/L): 156-672
ACS180 Expected Results - Deficient: Median (pg/mL): 160, Range (pg/mL): 32–246, Median (pmol/L): 118, Range (pmol/L): 24-181
ACS180 Precision:
Sample 1: Mean (pg/mL): 1147, Mean (pmol/L): 846, Within-run % CV: 2.68, Total % CV: 3.44
Sample 2: Mean (pg/mL): 661, Mean (pmol/L): 488, Within-run % CV: 2.70, Total % CV: 3.24
Sample 3: Mean (pg/mL): 204, Mean (pmol/L): 151, Within-run % CV: 3.73, Total % CV: 4.79
Sample 4: Mean (pg/mL): 169, Mean (pmol/L): 125, Within-run % CV: 5.33, Total % CV: 6.28
ADVIA Centaur Precision:
Sample 1: Mean (pg/mL): 178.76, Mean (pmol/L): 131.89, Within-run % CV: 5.0, Run-to-run % CV: 9.2, Total % CV: 10.4
Sample 2: Mean (pg/mL): 207.22, Mean (pmol/L): 152.89, Within-run % CV: 4.0, Run-to-run % CV: 4.4, Total % CV: 5.9
Sample 3: Mean (pg/mL): 608.83, Mean (pmol/L): 449.19, Within-run % CV: 2.7, Run-to-run % CV: 2.7, Total % CV: 3.8
Sample 4: Mean (pg/mL): 1343.87, Mean (pmol/L): 991.51, Within-run % CV: 2.4, Run-to-run % CV: 3.0, Total % CV: 3.9
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows a handwritten alphanumeric string. The string is "K993571". The characters are written in a simple, slightly slanted style.
Summary of Safety and Effectiveness
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitters Information
| Contact person: | Thomas F. Flynn
Manager of Regulatory Affairs |
|---------------------------------|------------------------------------------------------------------------|
| Address: | Bayer Diagnostics Corporation
63 North Street
Medfield, MA 02052 |
| Phone: | 508 359-3877 |
| Date Summary Prepared: | October 18, 1999 |
| 2. Device Information | |
| Proprietary Name: | Bayer Diagnostics ACS:180 VB12
Bayer Diagnostics ADVIA Centaur VB12 |
| Common Name: | Immunoassay for vitamin B12 |
| 3. Predicate Device Information | |
| Name: | Current legally marketed device (ACS:180 and ADVIA
Centaur VB12) |
Manufacturer:
Bayer Diagnostics Corporation
4. Device Description
The ACS:180 VB12 and ADVIA Centaur assays are competitive assays.
Vitamin B12, or cyanocobalamin, is a complex corrinoid compound containing four pyrrole rings that surround a single cobalt atom. Humans obtain vitamin B12 exclusively from animal dietary sources, such as meat, eggs, and milk. Vitamin B12 requires intrinsic factor, a protein secreted by the parietal cells in the gastric mucosa, for absorption. Vitamin B12 and intrinsic factor form a complex that attaches to receptors in the ileal mucosa, where proteins known as trans-cobalamins transport the vitamin B12 from the mucosal cells to the blood and tissues. Most vitamin B12 is stored in the liver as well as in the bone marrow and other tissues,
1
5. Statement of Intended Use
ACS180 VB12:
In vitro diagnostic use in the quantitative determination of vitamin B12 in serum. heparinized plasma, or EDTA plasma using the ADVIA Centaur System using the ACS:180® Automated Chemiluminescence Systems.
ADVIA Centaur:
In vitro diagnostic use in the quantitative determination of vitamin B12 in serum, heparinized plasma, or EDTA plasma using the ADVIA® Centaur System.
6. Summary of Technological Characteristics
The ACS:180 VB12 and ADVIA Centaur VB12 assays are competitive assays in which vitamin B12 from the patient sample competes with vitamin B12 labeled with acridinium ester in the Lite Reagent, for a limited amount of purified intrinsic factor, which is covalently coupled to paramagnetic particles in the Solid Phase. The assay uses Releasing Agent (sodium hydroxide) and DTT to release the vitamin B12 from the endogenous binding proteins in the sample and cobinamide to prevent rebinding after the Solid Phase is added to the sample.
7. Performance Characteristics
Expected Results:
To determine the reference range for the ACS:180 and ADVIA Centaur VB12 assays, data was obtained on 298 serum samples, including 253 samples from apparently healthy individuals and 45 samples from physician-diagnosed vitamin B12 deficient patients. Ninety-five percent of the serumACS:180 VB12 values for the apparently healthy individuals fell in the range of 211 to 911 pg/mL (156 to 672 pmol/L).
| Category | Median
(pg/mL) | Range
(pg/mL) | Median
(pmol/L) | Range
(pmol/L) |
|-----------|-------------------|------------------|--------------------|-------------------|
| Normal | 382 | 211–911 | 282 | 156-672 |
| Deficient | 160 | 32–246 | 118 | 24-181 |
Sensitivity and Assay Reportable Range:
The ACS:180 and ADVIA Centaur VB12 assays measures vitamin B12 concentrations up to 2000 pg/mL (1476 pmol/L) with a minimum detectable concentration of 30 pg/mL (22 pmol/L).
2
Serum Versus Plasma Method Comparison:
ACS 180:
A comparison of values for 213 pairs of serum and plasma specimens in the range of 160 to 1000 pg/mL (118 to 738 pmol/L) yielded the following regression equation: plasma VB12 = 1.04 (serum VB12) + 9 pg/mL, r = 0.96
ADVIA Centaur:
A comparison of values for 207 pairs of serum and plasma specimens in the range of 147 to 1033 pg/mL (108 to 762 pmol/L) yielded the following regression equation: plasma VB12 = 1.03 (serum VB12) + 12 pg/mL, r = 0.96
Precision:
ACS180:
Four samples were assayed 3 times in 7 assays, on each of 11 systems (n=231 for each sample), over a period of 5 days. The following results were obtained:
| Mean | Mean | Within-run | Total |
|---|---|---|---|
| (pg/mL) | (pmol/L) | % CV | % CV |
| 1147 | 846 | 2.68 | 3.44 |
| 661 | 488 | 2.70 | 3.24 |
| 204 | 151 | 3.73 | 4.79 |
| 169 | 125 | 5.33 | 6.28 |
ADVIA Centaur:
Four samples were assayed 6 times, in each of 12 runs, on 6 systems, (n = 72 for each sample), over a period of 3 days. The following results were obtained:
| Mean (pg/mL) | Mean
(pmol/L) | Within-run %
CV | Run-to-run %
CV | Total % CV |
|--------------|------------------|--------------------|--------------------|------------|
| 178.76 | 131.89 | 5.0 | 9.2 | 10.4 |
| 207.22 | 152.89 | 4.0 | 4.4 | 5.9 |
| 608.83 | 449.19 | 2.7 | 2.7 | 3.8 |
| 1343.87 | 991.51 | 2.4 | 3.0 | 3.9 |
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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three wing-like shapes extending upwards and to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC I 6 1999
Mr. Thomas F. Flynn Manager of Regulatory Affairs Bayer Corporation Business Group Diagnostics 63 North Street Medfield, Massachusetts 02052-1688
K993571 Trade Name: Chiron Diagnostics ACS:180 VB12 Assay Regulatory Class: II Product Code: CDD Dated: October 18, 1999 Received: October 21, 1999
Dear Mr. Flynn:
Re:
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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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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Page 2
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 Putman
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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Page ⊥ of ⊥
4993571 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Chiron Diagnostics ACS:180 VB12 Assay
Indications for Use:
In vitro diagnostic use in the quantitative determination of vitamin B12 in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur System.
Qeen Cooper
Division Sign-Off
ivision of Clinical Laboratory Devices 0(k) Number _ K 99
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR
| 510(k) Number (if known): | K910343 K993571 |
|---|---|
| --------------------------- | ----------------- |
Over-The-Counter Use (Optional Format 1-2-96)