(59 days)
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No
The description focuses on a standard immunoassay technology and does not mention any AI or ML components.
No.
This device is an immunoassay for quantitative determination of vitamin B12 levels, used for diagnosis and treatment of anemias, indicating it is a diagnostic tool, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption." This directly indicates its role as a diagnostic device.
No
The device is a reagent kit for an immunoassay, which is a chemical and biological assay performed on a physical analyzer. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for the "quantitative determination of vitamin B12 levels in human serum and plasma" and that the "Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption." This clearly indicates that the device is intended to be used in vitro (outside the body) to examine specimens (serum and plasma) for diagnostic purposes.
- Device Description: The description mentions it's a "paramagnetic particle, chemiluminescent immunoassay" and a "competitive binding immunoenzymatic assay," which are common techniques used in in vitro diagnostic tests. It also describes the components as a "reagent kit," "substrate," "calibrators," and "wash buffer," all typical elements of an IVD assay.
- Performance Studies: The performance studies described (Method Comparison, Imprecision, Linearity, LoB/LoD, LoQ) are standard types of studies conducted to validate the performance of in vitro diagnostic devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K955436) and the name "Access Vitamin B12 Assay" strongly suggests that this device is being compared to a previously cleared IVD device.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of vitamin B12 levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
Product codes (comma separated list FDA assigned to the subject device)
CDD
Device Description
The Access Vitamin B12 assay is a competitive binding immunoenzymatic assay. The Access Vitamin B12 reagent kit is in a liquid ready-to-use format designed for optimal performance on Beckman Coulter's immunoassay analyzers. Each reagent kit contains two reagent packs. Other items needed to run the assay include substrate, calibrators, and wash buffer.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison:
A method comparison study was completed to compare the Access Vitamin B12 assay on the Dxl 9000 Access Immunoassay Analyzer to the Access Vitamin B12 assay on the Access Immunoassay System using a protocol based on CLSI EP09c-A3. The results of the method comparison study met the acceptance criteria of R2 ≥ 0.90 and slope of 1.00 ± 0.14 and supports the equivalence of the Access Vitamin B12 assay on Dxl 9000 Access Immunoassay Analyzer to the Access Vitamin B12 assay on the Access instrument.
N: 122
Concentration Range (pg/mL): 70 - 1248
Slope: 1.00
Slope 95% CI: 0.96 - 1.02
Intercept: 6.1
Intercept 95% CI: -0.16 - 15
Correlation Coefficient R2: 0.97
Imprecision:
The imprecision study was run on three Dxl 9000 Access Immunoassay Analyzers, three reagent lots, and three calibrator lots. Six (6) serum samples, with varying Vitamin B12 concentrations, were assayed in duplicate with two runs per day, over 21 days. The assay was design to meet the requirements of imprecision of SD ≤ 12 pg/mL for values ≤ 100 pg/mL and CV ≤ 12.0 % for values > 100 pg/mL. The observed within-laboratory (total) % CV was between 2.7% and 7.7% for Vitamin B12 concentrations > 100 pg/mL. The within-laboratory (total) SD was between 6 – 9 for Vitamin B12 concentrations ≤ 100 pg/ml.
Linearity:
A verification study was performed to determine the linearity of the Access Vitamin B12 assay on the Dxl 9000 Access Immunoassay Analyzer based on CLSI EP06-ED2. The results of this study met the acceptance criterion and indicate that the Access Vitamin B12 assay is linear on the Dxl 9000 Immunoassay System throughout the analytical measuring interval (68 - 1,500 pg/mL (50 - 1,107 pmol/L).
LoB/LoD:
Verification studies were performed to determine the Limit of Blank (LoB) and Limit of Detection (LoD) of the Access Vitamin B12 assay using a protocol based on CLSI EP17-A2. The claimed LoB is 50 pg/mL (37 pmol/L). The assay is designed to meet the requirements for LoD ≤ 68 pg/mL (≤ 50 pmol/L). The results data demonstrate the LoB estimate of the vitamin B12 assay on Dxl 9000 is 35 pg/mL (26 pmol/L). The observed LoD of the Vitamin B12 assay on Dxl 9000 immunoassay analyzer is 49 pg/mL (36 pmol/L).
LoQ:
Verification studies were performed to determine the Limit of Quantitation (LoQ) of the Access Vitamin B12 assay using a protocol based on CLSI EP17- A2 The assay is designed to meet the requirements for LoQ ≤ 68 pg/mL (≤ 50 pmol/L). The results data demonstrate the 20% CV LoQ estimate for the Access Vitamin B12 assay is 42 pg/mL. The results demonstrate the LoQ at 20% within laboratory (total) CV estimate of the Access Vitamin B12 assay to be 68 pg/mL. The maximum observed LoQ estimate for the Access Vitamin B12 assay on the Dxl 9000 immunoassay system is less than the reported LoD value (49 pg/mL).
Following the CLSI EP17-A2 recommendation that the LoQ must be greater than or equal to LoD, the LoQ observed value is reported as 49 pg/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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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December 23, 2022
Beckman Coulter, Inc. Kuljeet Kaur Regulatory Affairs Manager 1000 Lake Hazeltine Drive Chaska, MN 55318-1084
Re: K223289
Trade/Device Name: Access Vitamin B12 Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: Class II Product Code: CDD Dated: October 25, 2022 Received: October 25, 2022
Dear Kuljeet Kaur:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Paula____ Caposino -S Date: 2022.12.23
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223289
Device Name Access Vitamin B12
Indications for Use (Describe)
The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of vitamin B12 levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Access Vitamin B12 510(k) Summary
510k Number: K223289
Date Prepared: December 23, 2022
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92
Submitted By:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Contact Person:
Kuljeet Kaur, Ph.D Regulatory Affairs Manager Phone: (952)-465-1914 Email: kkaur@beckman.com
Device Name:
Common Name: Access Vitamin B12 Assay Trade Name: Access Vitamin B12 Classification Name: Vitamin B12 test system Classification Product Code: CDD Regulation: 21 CFR 862.1810
Predicate Device: Device Name: Access Vitamin B12 Assay 510(k) Number: K955436
Device Description:
The Access Vitamin B12 assay is a competitive binding immunoenzymatic assay. The Access Vitamin B12 reagent kit is in a liquid ready-to-use format designed for optimal performance on Beckman Coulter's immunoassay analyzers. Each reagent kit contains two reagent packs. Other items needed to run the assay include substrate, calibrators, and wash buffer.
Intended Use:
The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of vitamin B12 levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements obtained by this device are used in the diaqnosis and treatment of anemias of gastrointestinal malabsorption.
Alternate Contact: Madhuri Boppana Senior Regulatory Affairs Analyst Email: mboppana@beckman.com
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| System
Attribute/Characteristic | Predicate Access Vitamin B12 on
Access Immunoassay System | Access Vitamin B12 on Dxl 9000
Access Immunoassay Analyzer |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Analyte Measured | Access Vitamin B12 | Same |
| Standardization | USP Reference Material | Same |
| Intended Use/ Indications
for Use | The Access Vitamin B12 assay is a
paramagnetic particle, chemiluminescent
immunoassay for the quantitative
determination of vitamin B12 levels in
human serum and plasma (heparin) using
the Access Immunoassay Systems. | Same |
| Solid Phase | Paramagnetic particles coated with goat
anti-mouse IgG; mouse monoclonal anti-
intrinsic factor | Same |
| Conjugate | Intrinsic factor-alkaline phosphatase | Same |
| Technology | Two-step competitive | Same |
| Format | Chemiluminescent | Same |
| Method | Automated | Same |
| Calibration | Utilizes a stored calibration curve | Same |
| Sample Type | Serum or plasma | Same |
| Reagent Pack formulation
and packaging | Access Reagent Pack formulation and
packaging. | Same |
| Stability | Stable at 2 to 10°C for 14 days after initial
use | Same |
| Substrate | Access Substrate | Lumi-Phos PRO Substrate |
| Measuring Range | 50 - 1,500 pg/mL (37 – 1,107 pmol/L) | 68 - 1,500 pg/mL (50 - 1,107
pmol/L) |
| Instrument | Access Immunoassay System | Dxl 9000 Access Immunoassay
Analyzer |
Comparison of Technological Characteristics to the Predicate
Summary of Studies:
Method Comparison:
A method comparison study was completed to compare the Access Vitamin B12 assay on the Dxl 9000 Access Immunoassay Analyzer to the Access Vitamin B12 assay on the Access Immunoassay System using a protocol based on CLSI EP09c-A3. The results of the method comparison study met the acceptance criteria of R2 ≥ 0.90 and slope of 1.00 ± 0.14 and supports the equivalence of the Access Vitamin B12 assay on Dxl 9000 Access Immunoassay Analyzer to the Access Vitamin B12 assay on the Access instrument.
| N | Concentration
Range*
(pg/mL) | Slope | Slope
95% CI | Intercept | Intercept
95% CI | Correlation
Coefficient
R2 |
|-----|------------------------------------|-------|-----------------|-----------|---------------------|----------------------------------|
| 122 | 70 - 1248 | 1.00 | 0.96 - 1.02 | 6.1 | -0.16 - 15 | 0.97 |
*Range is Access values
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Imprecision: The imprecision study was run on three Dxl 9000 Access Immunoassay Analyzers, three reagent lots, and three calibrator lots. Six (6) serum samples, with varying Vitamin B12 concentrations, were assayed in duplicate with two runs per day, over 21 days. The assay was design to meet the requirements of imprecision of SD ≤ 12 pg/mL for values ≤ 100 pg/mL and CV ≤ 12.0 % for values > 100 pg/mL. The observed within-laboratory (total) % CV was between 2.7% and 7.7% for Vitamin B12 concentrations > 100 pg/mL. The withinlaboratory (total) SD was between 6 – 9 for Vitamin B12 concentrations ≤ 100 pg/ml. The results from a representative lot are as follows:
| Concentration (pg/mL) | | Repeatability
(Within-Run) | | Between-Run | | Between-Day | | Within-
Laboratory | | |
|-----------------------|----|-------------------------------|------|-------------|-----|-------------|------|-----------------------|-----|------|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 84 | 71 | 6 | 9.0 | 0 | 0.0 | 6 | 8.5 | 9 | 12.4 |
| Sample 2 | 84 | 102 | 5.9 | 5.8 | 1.0 | 1.0 | 5.1 | 5.0 | 7.9 | 7.7 |
| Sample 3 | 84 | 196 | 5.6 | 2.9 | 3.3 | 1.7 | 5.5 | 2.8 | 8.6 | 4.4 |
| Sample 4 | 84 | 435 | 9.2 | 2.1 | 9.4 | 2.2 | 10.3 | 2.4 | 16. | 3.8 |
| Sample 5 | 84 | 944 | 28.3 | 3.0 | 26. | 2.8 | 27.5 | 2.9 | 47. | 5.0 |
| Sample 6 | 84 | 1179 | 71.9 | 6.1 | 0.0 | 0.0 | 33.5 | 2.8 | 79. | 6.7 |
Linearity: A verification study was performed to determine the linearity of the Access Vitamin B12 assay on the Dxl 9000 Access Immunoassay Analyzer based on CLSI EP06-ED2. The results of this study met the acceptance criterion and indicate that the Access Vitamin B12 assay is linear on the Dxl 9000 Immunoassay System throughout the analytical measuring interval (68 - 1,500 pg/mL (50 - 1,107 pmol/L).
LoB/LoD: Verification studies were performed to determine the Limit of Blank (LoB) and Limit of Detection (LoD) of the Access Vitamin B12 assay using a protocol based on CLSI EP17-A2. The claimed LoB is 50 pg/mL (37 pmol/L). The assay is designed to meet the requirements for LoD ≤ 68 pg/mL (≤ 50 pmol/L). The results data demonstrate the LoB estimate of the vitamin B12 assay on Dxl 9000 is 35 pg/mL (26 pmol/L). The observed LoD of the Vitamin B12 assay on Dxl 9000 immunoassay analyzer is 49 pg/mL (36 pmol/L).
LoQ: Verification studies were performed to determine the Limit of Quantitation (LoQ) of the Access Vitamin B12 assay using a protocol based on CLSI EP17- A2 The assay is designed to meet the requirements for LoQ ≤ 68 pg/mL (≤ 50 pmol/L). The results data demonstrate the 20% CV LoQ estimate for the Access Vitamin B12 assay is 42 pg/mL. The results demonstrate the LoQ at 20% within laboratory (total) CV estimate of the Access Vitamin B12 assay to be 68 pg/mL. The maximum observed LoQ estimate for the Access Vitamin B12 assay on the Dxl 9000 immunoassay system is less than the reported LoD value (49 pg/mL).
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Following the CLSI EP17-A2 recommendation that the LoQ must be greater than or equal to LoD, the LoQ observed value is reported as 49 pg/mL.
Other claims: The claims for the analytical specificity, reference intervals, matrix comparison are being transferred from file K955436.
Substantial Equivalence Comparison Conclusion
Beckman Coulter's Access Vitamin B12 Assay on the Dxl 9000 Access Immunoassay Analyzer is substantially equivalent to the Access Vitamin B12 Assay on the Access Immunoassay System as demonstrated through the information and data provided in this submission. The performance testing presented in this submission provides evidence that the device is safe and effective in its intended use.