Fujirebio Diagnostics Vitamin D Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of Vitamin D.

Device Description

This quality control product can be used as an objective judgment of the laboratory's procedures and personnel techniques. It is a valuable tool to assess good laboratory practices. Three levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range.

AI/ML Overview

This document is a 510(k) Premarket Notification for a Vitamin D Control product, not an AI-powered device. Therefore, many of the requested criteria regarding AI technology, such as sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, and training set details, are not applicable.

The document describes the Fujirebio Diagnostics Vitamin D Control, which is an assayed control serum intended to monitor the precision of laboratory testing procedures for the analysis of Vitamin D. This is a quality control material, not a diagnostic device that performs analysis or requires AI.

Acceptance Criteria and Device Performance:

The document focuses on establishing substantial equivalence to a predicate device (Bio-Rad Liquichek™ Specialty Immunoassay Control - 25-OH Vitamin D component, K043108). This means the "acceptance criteria" are essentially the demonstration that the proposed device performs comparably to the legally marketed predicate device for its intended use, which is monitoring the precision of laboratory testing for Vitamin D.

The document does not provide specific quantitative "reported device performance" in terms of clinical accuracy (e.g., sensitivity, specificity, or AUC) as it is a control material, not a diagnostic test with a clinical outcome. Instead, it highlights similarities in intended use, device type, classification, regulatory information, analyte, matrix, and number of levels.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document for a control product):

Acceptance Criterion (Similarity to Predicate)	Reported Device Performance (Proposed Device)
Intended Use	Intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of Vitamin D.
Device Type	In vitro diagnostic
Classification	Class I
CFR Section	862.1660
Product Usage	Clinical and Hospital laboratories
Analyte	25(OH) Vitamin D
Matrix	Human Serum, protein (bovine), purified biochemical materials, and chemicals. Proclin 300 and Gentamicin as preservatives.
Number of Levels	3

Details Not Applicable to this Device Type (Quality Control Material):

Sample sized used for the test set and the data provenance: Not applicable. This is a control material, not a diagnostic test evaluated on patient samples. The "studies" involve demonstrating lot-to-lot consistency and stability, and establishing expected ranges across different analyzers. These details are not provided in the 510(k) summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" established by experts for a control material in the same way as for a diagnostic test.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. For a control material, "ground truth" would relate to the assigned target values and acceptable ranges which are determined through extensive testing and characterization against reference methods or established internal standards. These specific methods are not detailed in the 510(k) summary.
The sample size for the training set: Not applicable. This is not an AI device.
How the ground truth for the training set was established: Not applicable. This is not an AI device.

In summary, this 510(k) submission is for a quality control product, not an AI or image analysis device. Therefore, the detailed questions related to AI-specific study designs and performance metrics are not relevant to this document. The "study" referenced in the 510(k) process is primarily a demonstration of substantial equivalence to an existing predicate device through comparison of features and intended use.

Summary

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Premarket Notification (510(k)) Tumor Marker Control

Image /page/0/Picture/1 description: The image shows the date "MAY 27 2011" on the left side. On the right side, there is a handwritten "K110641". Below the date, there is a logo for "FUJIREBIO Diagnostics, Inc.". The logo includes a stylized graphic element to the left of the text.

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:

Submitter Information

Address:

Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355

Stacey Dolan Contact person: (610) 240-3843 dolans@fdi.com
Summary preparation date: March 2, 2011

Name of Device

Trade/Proprietary Name:	Fujirebio Diagnostics Vitamin D Control
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Common/Usual Name: Quality control material (assayed and unassayed).

21 CFR 862.1660 Regulation Number:

Regulatory Class: Class |

JJX Product Code:

Predicate Device

Bio-Rad Liquichek" Specialty Immunoassay Control (K043108) - 25-OH Vitamin D component

Summary and Principle

Intended Use

Fujirebio Diagnostics Vitamin D Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of Vitamin D.

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Statement of Substantial Equivalence

Fujirebio Diagnostics Vitamin D Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of Vitamin D.

The Fujirebio Diagnostics Vitamin D Control is substantially equivalent to the 25-OH Vitamin D
component of the Bio-Rad Liquichek" Specialty Immunoassay Control. Both of the quality control serum and are used to monitor the precision of laboratory testing procedures for Vitamin D.

The regulatory submission is prepared pursuant to Title 21CFR § 862.1660.

A comparison of the features of the Fujirebio Diagnostics Vitamin D Control and the 25-0H Vitamin D component of Bio-Rad Liquichek" Specialty Immunoassay Control are as follows:

Similarities
	Fujirebio Diagnostics Vitamin DControl(Proposed Device)	Bio-Rad Liquichek™ SpecialtyImmunoassay Control - 25-OHVitamin D(Predicate Device)K043108
Device Type	In vitro diagnostic	In vitro diagnostic
Classification	Class I	Class I
CFR section	862.1660	862.1660
Product Usage	Clinical and Hospital laboratories	Clinical and Hospital laboratories
Intended Use	The Fujirebio Diagnostics VitaminD Control is intended for use as anassayed control serum to monitorthe precision of laboratory testingprocedures for the analysis ofVitamin D.	Liquichek Specialty ImmunoassayControl is intended for use as aquality control serum to monitorthe precision of laboratory testingprocedures for the analytes listedin the package insert.
Analyte	25(OH) Vitamin D	25(OH) Vitamin D
Matrix	Human Serum, protein (bovine),purified biochemical materials, andchemicals. Proclin 300 andGentamicin as preservatives.	Human Serum with addedconstituents of human and animalorigin, chemicals, stabilizers andpreservatives.
Number of Levels	3	3

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Differences
	Fujirebio Diagnostics VitaminD Control(Proposed Device)	Bio-Rad Liquichek™ SpecialtyImmunoassay Control - 25-OHVitamin D(Predicate Device)K043108
Reconstitution Volume	2.0 mLs	5.0 mLs
Vitamin DAnalyte Forms	25(OH) Vitamin D225(OH) Vitamin D3	25(OH) Vitamin D3
Other Analytes	Contains only 25(OH) Vitamin D	Contains also:Anti-TgAnti-TPOC-peptideErythropoietin (EPO)Intact PTH (iPTH)IGF-IOsteocalcin
Storage (unopened)	12 months at 2 to 8°C	2 years at -20°C to -70°C
Form	Lyophilized	Liquid
Product Code	JJX	JJY

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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Fujirebio Diagnostics, Inc. c/o Ms. Stacey Dolan Manager, Regulatory Affairs 201 Great Valley Parkway Malvern, PA 19355

MAY 2 7 2011

K110641 Trade Name: Fujirebio Diagnostics Vitamin D Control Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I, reserved Product Codes: JJX Dated: March 03, 2011 Received: March 04, 2011

Dear Ms. Dolan:

Re:

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).

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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

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/cdrh/industry/support/index.html.

Sincerely yours,

CJC.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Fujirebio Diagnostics Vitamin D Control

Indications for Use:

Fujirebio Diagnostics Vitamin D Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of Vitamin D.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110641

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Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.