The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holotranscobalamin (HoloTC) in human serum. HoloTC (vitamin B12 bound to transcobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.

Device Description

The Axis-Shield Active-B12 (Holotranscobalamin) device contains the following components: a microtitre plate with 8 x 12-well breakapart strips coated with a anti-holotranscobalamin murine monoclonal antibody, in a resealable foil pack with desiccant; ready-to-use calibrators, low and high controls (phosphate buffer containing protein (bovine) stabiliser and sodium azide preservative with or without recombinant HoloTC); ready-to-use pre-treatment solution; murine anti-human transcobalamin alkaline phosphatase conjugate; para-NitroPhenyl Phosphate (pNPP) substrate; wash buffer (8x); ready-to-use stop solution.

AI/ML Overview

Here is a breakdown of the acceptance criteria and study information for the Axis-Shield Active-B12 (Holotranscobalamin) device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Predicate)	Reported Device Performance (Axis-Shield Active-B12)
Intended Use	Quantitative determination of Holotranscobalamin in human serum, aid in diagnosis and treatment of vitamin B12 deficiency.	Quantitative determination of holotranscobalamin (HoloTC) in human serum, aid in diagnosis and treatment of vitamin B12 deficiency.
Antibodies Employed	Murine monoclonal antibody 3C4, Murine monoclonal antibody 3-11	Murine monoclonal antibody 3C4, Murine monoclonal antibody 3-11
Specimen Type	Serum and Serum Separator	Serum and Serum Separator
Measuring Interval	5.0 to 128.0 pmol/L	10 to 128 pmol/L
Detection Limits	Limit of Quantitation of ≤ 5.0 pmol/L	Limit of Quantitation of 8.3 pmol/L (Limit of Blank: 4.9 pmol/L, Limit of Detection: 8.1 pmol/L)
Linearity on Dilution	LOQ to Calibrator F	LOQ to Calibrator F (demonstrated linearity from 5.3 to 156.0 pmol/L)
Expected Values (95% range) in Asymptomatic Population	25.1 to 165.0 pmol/L (n=181)	21 to 123 pmol/L (n=135)
Cross-reactivity (Apotranscobalamin)	No detectable carryover with Apotranscobalamin at 500 pmol/L	Maximum deviation in holotranscobalamin concentration of ≤10% in the presence of 500 pmol/L apotranscobalamin (ranged from -5% to 1%).
Cross-reactivity (Haptocorrin)	No detectable carryover with Haptocorrin at 5000 pmol/L	Maximum deviation in holotranscobalamin concentration of ≤10% in the presence of 5000 pmol/L haptocorrin (ranged from -5% to 1%).
Interference (Bilirubin)	≤ 10% with Bilirubin at 20 mg/dL	Maximum deviation in holotranscobalamin concentration of ≤10% with Bilirubin at 30 mg/dL (reported no interference found up to 300 mg/dL in separate table for device performance).
Interference (Haemoglobin)	≤ 10% with Haemoglobin at 200 mg/dL	Maximum deviation in holotranscobalamin concentration of ≤10% with Haemoglobin at 5 mg/mL (reported no interference found up to 500 mg/dL in separate table for device performance).
Interference (Triglycerides)	≤ 10% with Triglycerides at 850 mg/dL	Maximum deviation in holotranscobalamin concentration of ≤10% with Triglycerides at 30 mg/mL (reported no interference found up to 3000 mg/dL in separate table for device performance).
Interference (Rheumatoid Factor)	≤ 10% with Rheumatoid Factor at 70 IU/mL	Maximum deviation in holotranscobalamin concentration of ≤10% with Rheumatoid Factor at 75 IU/mL (reported no interference found up to 7500 IU/dL in separate table for device performance).
Interference (Total Protein)	≤ 10% with Total protein at 10 g/dL	Maximum deviation in holotranscobalamin concentration of ≤10% with Total protein at 90 mg/mL (reported no interference found up to 9000 mg/dL in separate table for device performance).
Imprecision (Total %CV)	≤ 5.8%	≤ 11.5% (observed range from 4.8% to 11.5% across various samples and conditions)
Imprecision (Within-run %CV)	< 4.4%	≤ 9.4% (observed range from 3.1% to 9.4% across various samples and conditions)
Matrix Comparison (Serum clot vs SST) - Slope	> 0.97	> 0.97
Matrix Comparison (Serum clot vs SST) - Correlation (r)	0.98	0.98
Matrix Comparison (Serum clot vs SST) - Overall % bias	< 2.5	< 2.5
Method Comparison (Slope)	Not explicitly stated as acceptance criteria, but predicate value is inherent in "substantially equivalent"	0.95 (0.89 to 1.01)
Method Comparison (Correlation (r))	Not explicitly stated as acceptance criteria, but predicate value is inherent in "substantially equivalent"	0.93 (0.90 to 0.95)

Note: The acceptance criteria are largely derived from the performance claims of the predicate device, as the submission aims to demonstrate substantial equivalence to it. Where specific numerical "acceptance criteria" are not listed for the predicate, the comparison is made to the predicate's reported performance or general principles of equivalence. For interference, the "≤ 10% deviation" acts as an acceptance criterion for the subject device.

2. Sample size used for the test set and the data provenance

Dilution Linearity: Not explicitly stated as a sample size, but linearity was demonstrated "across the measuring range of the assay from 5.3 to 156.0 pmol/L." This typically involves a series of dilutions of a high-concentration sample. Data provenance not specified but likely derived from lab studies.
Analytical limits at low levels (Limit of Blank, Detection, Quantitation): No specific sample size provided, stated as "a representative study." Data provenance not specified, likely lab-generated.
High Dose Hook: No sample size provided, determined by testing up to 2236 pmol/L Holotranscobalamin. Data provenance not specified, likely lab-generated.
Cross-reactivity: No specific sample size provided, determined by testing in the presence of 500 pmol/L apotranscobalamin or 5000 pmol/L haptocorrin. Data provenance not specified, likely lab-generated.
Interference: No specific sample size provided, determined by testing in the presence of various interfering compounds at specific concentrations. Data provenance not specified, likely lab-generated.
Precision: 8 human serum samples were used, each assayed 80 times across 3 lots, 2 operators, and 5 days. This sums to 640 individual measurements (8 samples * 80 replicates) for the human serum samples, plus 80 replicates each for a low and a high control. Data provenance not specified, but the use of "human serum samples" suggests clinical samples, likely retrospective.
Matrix Comparison: > 36 specimens were used for the correlation study comparing serum (clot) and serum separator (SST) tubes. Data provenance not specified, likely retrospective from a clinical setting.
Method Comparison: 111 specimens from apparently healthy adults were used. Data provenance not specified, but the description "apparently healthy adults" suggests prospective collection or selection from a healthy cohort.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This device is an in-vitro diagnostic assay for quantitative determination of a biomarker (Holotranscobalamin). The ground truth for such assays is typically established through:

Reference Methods: Comparison to established, clinically validated methods (like the predicate device) or gold standard analytical techniques.
Known Concentrations: Use of samples with known, spiked concentrations for analytical performance validation (e.g., linearity, detection limits).
Clinical Diagnosis: Correlating assay results with clinical diagnosis of B12 deficiency (though a direct study for this is not detailed for the subject device beyond the general "aid in diagnosis").

Thus, the ground truth is established through laboratory measurements and comparison to a legally marketed predicate device, rather than through expert consensus on diagnostic images or interpretations. Therefore, there were no human experts establishing the ground truth in the way described (e.g., radiologists interpreting images).

4. Adjudication method for the test set

Not applicable, as this is a quantitative diagnostic assay. Adjudication methods like 2+1 or 3+1 are typically used for qualitative or interpretive tasks, often in imaging, where human experts might disagree.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an immunoassay device, not an AI-assisted diagnostic tool that aids human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, this device is a standalone (algorithm only) device if you consider the "algorithm" to be the immunoassay protocol and the detector quantifying the colored end-product. There is no human-in-the-loop for the final quantitative result generation from the assay. The intent is for the device to provide a direct quantitative holotranscobalamin level.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for demonstrating substantial equivalence and performance was primarily based on:

Comparison to the predicate device: The ARCHITECT Active-B12 (Holotranscobalamin) assay served as the reference standard for the method comparison study. This implies the predicate's results were considered the "ground truth" for comparative purposes.
Analytical validation standards: For metrics like linearity, detection limits, cross-reactivity, and interference, the ground truth is established by carefully prepared samples with known concentrations or compositions, following established analytical chemistry principles.
Internal reference materials/controls: For precision studies, characterized control samples with established mean values are used.

8. The sample size for the training set

This device is a traditional immunoassay, not a machine learning or AI algorithm in the modern sense that requires a "training set" for model development. Therefore, there is no explicit training set as would be understood in AI/ML validation. The development and optimization of the assay would have involved various experimental batches and iterative improvements, but these do not constitute a formal "training set" in the context of AI regulatory submissions.

9. How the ground truth for the training set was established

Not applicable, as there is no formal "training set" in the AI/ML sense. The development of the assay involved standard biochemical and immunological research and development processes.

Summary

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K121946

Owners Name:

Axis-Shield Diagnostics Ltd. The Technology Park, Dundee DD2 1XA, UK Tel. +44(0) 1382 422 000 Fax. +44(0) 1382 422 088

Name of contact person:

Dr Simon Richards QA/RA Director Axis-Shield Diagnostics Ltd.

Date summary prepared:

March 8th, 2013

Device Name: Axis-Shield Active-B12 (Holotranscobalamin)

Classification Name: Vitamin B12 test system Trade Name: Axis-Shield Active-B12 (Holotranscobalamin) Common Name: Holotranscobalamin test Governing Regulation: 862.1810 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: CDD

Legally marketed device to which equivalency is claimed: ARCHITECT Active-B12 (Holotranscobalamin) (K112443)

Axis-Shield Active-B12 (Holotranscobalamin), K121946 510(k) Summary Final

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Intended Use of Device:

Description of Device:

Principle of the Assay:

The microtitre wells are coated with a highly specific monoclonal antibody for Active-B12 (Holotranscobalamin). During the first incubation holotranscobalamin in serum specifically binds to the antibody-coated surface. In the second incubation the Conjugate binds to any captured holotranscobalamin. The wells are then washed to remove unbound components. Bound holotranscobalamin is detected by incubation with the Substrate. Addition of Stop Solution terminates the reaction, resulting in a coloured end-product. The concentration of holotranscobalamin in pmol/L is directly related to the colour generated and can be estimated by interpolation from a dose-response curve based on Calibrators.

Comparison of Technological Characteristics:

Axis-Shield Active-B12 (Holotranscobalamin) and ARCHITECT Active-B12 (Holotranscobalamin) are both immunoassays for the quantitative determination of Holotranscobalamin (HoloTC) in human serum.

The predicate device is an automated Chemiluminescent mircoparticle immunoassay (CMIA) whereas the submission device is a manual enzyme-linked immunosorbent assays also demonstrated substantial equivalence in terms antibodies employed and units of measure.

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							Comparison of the subject device with the predicate device:
--	--	--	--	--	--	--	-------------------------------------------------------------	--

	Submission device	Predicate device
Parameter	Axis-Shield Active-B12 (Holotranscobalamin)
Intended use	The Axis-Shield Active-B12(Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitativedetermination of holotranscobalamin(HoloTC) in human serum. HoloTC (vitaminB12 bound to transcobalamin) is used as anaid in the diagnosis and treatment of vitaminB12 deficiency.	Chemiluminescent microparticleimmunoassay (CMIA) for the quantitativedetermination of Holotranscobalamin inhuman serum on the ARCHITECT i System.Active-B12 (Holotranscobalamin) is used asan aid in the diagnosis and treatment ofvitamin B12 deficiency.
Antibodies employed	Murine monoclonal antibody 3C4Murine monoclonal antibody 3-11	Murine monoclonal antibody 3C4Murine monoclonal antibody 3-11
Substrate / SignalGeneration	Alkaline phosphatase	Acridinium Tracer
Specimen type	Serum and Serum Separator	Serum and Serum Separator
Storage conditions	2-8°C.	2-8°C.
Calibration	6-point calibration curve.Linear regression curve-fit	6-point calibration curve.4PLC Y-weighted
Measuring Interval	10 to 128 pmol/L	5.0 to 128.0 pmol/L
Detection Limits	Limit of Quantitation of 8.3 pmol/L	Limit of Quantitation of ≤ 5.0 pmol/L
Linearity on Dilution	LOQ to Calibrator F	LOQ to Calibrator F
Expected Values inAsymptomaticPopulation	The mean Holotranscobalamin concentration(derived from log-transformed data tonormalize the population) was 72 pmol/Lwith a range from 15 to 147 pmol/L.The central 95% of the population definedthe expected range of21 to 123pmol/L (n= 135)	The mean Holotranscobalaminconcentration (derived from log-transformed data to normalize thepopulation) was 71.9pmol/L with a rangefrom 20.6 to 196.7 pmol/L.The central 95% of the population definedthe expected range of25.1 to 165.0 pmol/L (n=181)
Cross-reactivity	No detectable carryover with;Apotranscobalamin at 500 pmol/LHaptocorrin at 5000 pmol/L	No detectable carryover with;Apotranscobalamin at 500 pmol/LHaptocorrin at 5000 pmol/L
Interference	≤ 10% with;Bilirubin at 0.3 mg/mLHaemoglobin at 5 mg/mLTriglycerides at 30 mg/mLRheumatoid Factor at 75 IU/mLTotal protein at 90 mg/mL	≤ 10% with;Bilirubin at 20 mg/dLHaemoglobin at 200 mg/dLTriglycerides at 850 mg/dLRheumatoid Factor at 70 IU/mLTotal protein at 10 g/dL
Imprecision	Total %CV ≤ 12%Within-run %CV ≤ 9%	Total %CV ≤ 5.8%Within-run %CV < 4.4%

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Summary of Non-Clinical Performance:

Axis-Shield Active-B12 (Holotranscobalamin) The ARCHITECT Active-B12 (Holotranscobalamin) are both immunoassays for the quantitative determination of Holotranscobalamin (HoloTC) in human serum.

The Axis-Shield Active-B12 (Holotranscobalamin) assay demonstrated substantially equivalent performance to the ARCHITECT Active-B12 (Holotranscobalamin). A summary of the nonclinical performance data included in this 510(k) submission has been presented.

Dilution Linearity

The Axis-Shield Active-B12 (Holotranscobalamin) EIA demonstrated linearity across the measuring range of the assay from 5.3 to 156.0 pmol/L.

Reportable Range

The Axis-Shield Active-B12 (Holotranscobalamin) ElA reportable range is 10 to 128 pmol/L.

Analytical limits at low levels

a representative study, the limit of blank of the Axis-Shield ln Active-B12 (Holotranscobalamin) ElA was 4.9 pmol/L, the limit of detection was 8.1 pmol/L and the limit of quantification was 8.3 pmol/L.

High Dose Hook

No high dose hook effect was detected up to a concentration of 2236pmol/L Holotranscobalamin.

Cross-reactivity

The Axis-Shield Active-B12 (Holotranscobalamin) EIA is designed to have a maximum deviation in holotranscobalamin concentration of ≤10% in the presence of 500 pmol/L apotranscobalamin or 5000 pmol/L haptocorrin. The maximum deviation in holotranscobalamin concentration ranged from -5% to 1%.

Interference

The Axis-Shield Active-B12 (Holotranscobalamin) EIA is designed to have a maximum deviation in holotranscobalamin concentration of ≤10% in the presence of potentially interfering compounds. The maximum deviation in holotranscobalamin concentration ranged from -10% to 8% for the potentially interfering compounds presented.

Potential Interfering Substance	No interference found up to thefollowing concentration
Haemoglobin	500 mg/dL
Bilirubin	30 mg/dL
Triglyceride (Intralipid Solution)	3000 mg/dL
Rheumatoid Factor	7500 IU/dL
Total Protein	9000 mg/dL

Axis-Shield Active-B12 (Holotranscobalamin), K121946 510(k) Summary Final

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Precision-

8 human serum samples were assayed using 3 lots of reagents. Samples were assayed by 2 operators in replicates of 8, once a day for 5 days (total n=80). Data from this study are summarised in the following table: :

Sample	n	Lot	Operator	Mean (pmol/l)	Intra-assay %CV	Total %CV
1 A	80	1	1	17.8	7.5%	8.2%
		1	2	17.5	3.1%	9.3%
		2	1	20.1	6.0%	6.6%
		2	2	20.3	6.9%	9.2%
		3	1	19.1	5.5%	8.0%
		3	2	18.9	8.5%	11.0%
2 A	80	1	1	21.8	5.5%	9.9%
		1	2	21.8	3.9%	7.5%
		2	1	22.6	5.6%	8.7%
		2	2	23.5	9.0%	10.3%
		3	1	23.9	7.0%	10.2%
		3	2	23.2	5.8%	8.9%
3 A	80	1	1	28.8	3.8%	7.8%
		1	2	30.7	4.3%	9.6%
		2	1	31.0	6.8%	8.0%
		2	2	31.4	4.3%	6.1%
		3	1	31.5	4.5%	6.4%
		3	2	32.2	4.0%	9.2%
4 A	80	1	1	49.3	3.9%	7.4%
		1	2	52.6	4.1%	6.7%
		2	1	50.8	5.6%	10.0%
		2	2	51.7	4.7%	5.9%
		3	1	52.6	4.6%	4.8%
		3	2	55.0	5.5%	6.1%
5 A	80	1	1	68.4	4.0%	7.6%
		1	2	73.2	3.7%	7.5%
		2	1	74.8	4.3%	8.2%
		2	2	75.9	4.6%	6.4%
		3	1	75.1	4.4%	7.9%
		3	2	76.3	4.9%	6.2%
7 A	80	1	1	115.9	4.2%	5.9%
		1	2	121.1	3.6%	7.0%
		2	1	123.2	4.3%	10.2%
		2	2	124.0	4.2%	6.4%
		3	1	127.0	4.8%	10.1%
		3	2	129.5	3.2%	5.6%
LowControl	80	1	1	23.7	9.4%	10.9%
		1	2	23.8	5.1%	11.5%
		2	1	20.0	6.0%	7.5%
		2	2	18.6	5.8%	8.5%
		3	1	20.3	8.3%	9.7%
		3	2	20.1	8.3%	10.0%
HighControl	80	1	1	61.2	6.3%	6.4%
		1	2	58.8	4.5%	8.9%
		2	1	50.3	6.3%	8.1%
		2	2	50.2	5.9%	8.4%
		3	1	52.2	7.7%	9.2%
		3	2	50.8	5.8%	8.5%

Axis-Shield Active-B12 (Holotranscobalamin), K121946

510(k) Summary

Final

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Matrix Comparison

Specimens collected in serum (clot) and serum separator (SST) tubes are compatible in the Axis-Shield Active-B12 (Holotranscobalamin) assay shown by a correlation study. The data obtained gave the following statistical values:

Axis-Shield Active-B12 (Holotranscobalamin) EIA - Serum clot versus Serum Separator
Number of Specimens (n)	> 36
Slope of regression line (Passing-Bablok regression)	> 0.97
Correlation coefficient (r) (Pearson)	0.98
Overall percent bias (%)	< 2.5

Summary of Clinical Performance:

The Axis-Shield Active-B12 (Holotranscobalamin) assay demonstrated substantially equivalent clinical performance to the ARCHITECT Active-B12 (Holotranscobalamin) as indicated by a method comparison study.

Method Comparison

A correlation study was performed with serum specimens from apparently healthy adults. All specimens were analysed using the Axis-Shield Active-B12 (Holotranscobalamin) EIA and a commercially available assay for Holotranscobalamin according to the CLSI document EP9-A2. Specimen concentrations ranged from 13.8 to 112.8 pmol/L in the assay. The data obtained gave the following statistical values:

Axis-Shield Active-B12 (Holotranscobalamin) ElA versus a commercially available assay
Number of specimens	111
Slope of regression line (Passing-Bablok regression) (95% Cl)	0.95 (0.89 to 1.01)
Y-intercept (Passing-Bablok regression) (95% CI)	8.39 (5.73 to 11.77)
Correlation coefficient (r) (Pearson) (95% Cl)	0.93 (0.90 to 0.95)

Conclusion:

Based on the performance characteristics the Axis-Shield Active-B12 (Holotranscobalamin) assay (K121946) is substantially equivalent to the predicate device.

Axis-Shield Active-B12 (Holotranscobalamin), K121946 510(k) Summary Final

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 22, 2013

Axis-Shield Diagnostics, Ltd. c/o Simon J. Richards, PhD The Technology Park, Luna Place Dundee. Scotland United Kingdom, DD2 1XA

Re: K121946

Trade/Device Name: Axis-Shield Active-B12 (Holotranscobalamin) Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: Class II Product Code: CDD Dated: February 08, 2013 Received: February 11, 2013

Dear Dr. Richards:

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 Dr. Richards

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Carol G. Benson -S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known): K121946

Device Name: Axis-Shield Active-B12 (Holotranscobalamin)

Indication For Use:

For in vitro diagnostic use.

Prescription Use _ X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K121946

Regulation Number and Section

§ 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.