The Multichem WBT control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The Multichem WBT control consists of 3 different levels of control solutions prepared from human whole blood.

Device Description

Technopath has developed whole blood control materials prepared from human whole blood, to which whole blood purified biochemical material (extracts of human origin), chemicals, drugs, preservatives and stabilizers have been added. Three levels of control are available to allow performance monitoring within the analytical range.

AI/ML Overview

The provided document is a 510(k) summary for the Multichem WBT control, a quality control material used to monitor the precision of laboratory testing procedures for specific analytes (Cyclosporine, Sirolimus, Tacrolimus).

It describes the device, its intended use, comparison to a predicate device, and performance characteristics focused on traceability, value assignment, and stability. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC) against a ground truth through a clinical study involving human readers or standalone algorithm performance.

The "performance characteristics" detailed in the document refer to:

Traceability Summary: States the analytes are from commercial sources or endogenous to the base matrix, and no claim of traceability to higher order reference materials is made. This is not a measure of accuracy against a clinical ground truth.
Value Assignment Summary: Describes how typical values for the control material were determined using an Abbott ARCHITECT i2000 chemistry system. It involved 2 reagent lots, 2 calibrator lots, 16 runs (32 data points), and 8 calibration events. The "predetermined criteria of 30% around the grand mean" was used to establish value assignment ranges, and all values fell within these ranges. This is about establishing the expected range for the control itself, not about its diagnostic accuracy or impact on human performance.
Stability Testing Summary: Details open-vial and shelf-life stability studies. Open-vial stability was assessed using CLSI EP25A, with a maximum allowable drift (degradation) of 10% to determine the point of failure. Shelf-life was supported by accelerated and preliminary real-time testing using CLSI EP25A, also with a 10% drift limit, predicting stability for 30 months. This relates to the product's physical and chemical integrity over time, not its performance in a diagnostic context.

Since the device is a quality control material, the typical metrics for a diagnostic device (like sensitivity, specificity, reader performance) are not applicable in this context. The "performance" here refers to the consistency and stability of the control material itself.

Therefore, the requested information elements cannot be fully addressed in the format of a typical diagnostic device study due to the nature of the device (a quality control material).

However, I can extract the relevant information where it exists:

1. A table of acceptance criteria and the reported device performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Value Assignment	Value assignment ranges established at 30% around the grand mean.	Values for the lots tested all fell within the established ranges.
Open Vial Stability	Maximum allowable drift (degradation) of 10%.	Tacrolimus & Cyclosporine: 10 days at 2 to 8ºC. Sirolimus: 7 days at 2 to 8ºC.
Shelf-Life Stability	Drift Limit of 10% for accelerated and preliminary real-time testing.	Predicted to be stable for in excess of 30 months when stored at -20°C to -80°C. (Real-time testing is ongoing). Product claim: 30 months at -20° to -80°C.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Value Assignment:
- Test Set Sample Size: 32 data points (replicates from 16 runs)
- Data Provenance: Not explicitly stated, but performed internally by Technopath. Implied prospective as it was done to determine typical values for the product.
Stability Testing:
- Test Set Sample Size: "Multiple time points" tested for open-vial stability; three lots of controls for accelerated testing; three lots of controls for preliminary real-time testing.
- Data Provenance: Not explicitly stated, but performed internally by Technopath. Prospective studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable (N/A): This device is a quality control material, not a diagnostic device that requires expert-established ground truth for diagnostic accuracy. The "ground truth" for this device relates to its chemical properties and performance on a specific analytical instrument.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A: As above, this is not a diagnostic device requiring adjudication of expert interpretations.

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

N/A: This is not a diagnostic device, and thus no MRMC study, human reader improvement, or AI assistance is relevant.

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

N/A: This is a physical quality control material, not an algorithm. Its performance is measured through its interaction with an analytical instrument (Abbott ARCHITECT i2000).

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

Value Assignment: The "truth" is an internally determined grand mean, against which individual measurements were compared to establish ranges. This is a form of internal reference standard based on instrument performance.
Stability Testing: The "truth" is the initial established value of the control material, and subsequent measurements over time are compared against this initial value to determine drift/degradation.

8. The sample size for the training set

N/A: This device is a quality control material and does not involve AI model training. The performance studies described are for quality control and stability, not for training a predictive model.

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

N/A: As there is no training set for an AI model, this is not applicable.

Summary

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510(k) Summary Multichem WBT Control

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: K132174

1.0 Submitter

Paula McCarthy Head of Quality and Regulatory Affairs Technopath Fort Henry Business Park Ballina, Co. Tipperary Ireland Telephone: + 353 61 335844 Fax: + 353 61 203034 Email: paula.mccarthy@techno-path.com

SEP 20 2013

2.0 Date Sumbitted

August 16, 2013

3.0 Device Identification

Proprietary Names: Multichem WBT Common Name: Drug mixture and clinical toxicology control materials Classification: Class 1, Reserved Product Code: DIF Regulation Number: 21 CFR 862.3280

4.0 Legally Marketed Predicate Device

Candidate(s)	Predicate	Manufacturer	Document Number
Multichem WBT	Lyphocheck® WholeBlood ImmunosuppressantControl	Bio-RadLaboratories	K072721

The Multichem WBT control is substantially equivalent to the Bio-Rad product listed above, currently in commercial distribution.

UK Inl + 44 101 78 3083380 UK Fax + 44 101 28 30833650

TECHNOPAΤΗ
Fort Henry Business Park,
Batara. Co Tipperary, Ireland
E-mat: inlar techno-path.com

TECHNOPATH Manufacturing.
Registered in Ireland no. 419288
Registered office as above
www.techno-path.com

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5.0 Device Description

Each donor unit used in the preparation of the control material was tested by United States Food and Drug Administration (FDA) approved methods and found to be negative for antibodies to HIV and HCV, and nonreactive for HBsAg; However, because no test method can offer complete assurance that HIV, hepatitis B virus and hepatitis C virus or other infectious agents are absent, this material should be handled as though capable of transmitting infectious diseases. This product may also contain other human source material for which there is no approved test. It is recommended that this material be handled in accordance with the OSHA Standard on Blood borne Pathogens.

6.0 Intended Use

The Multichem WBT control is intended for use as an assaved quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The Multichem WBT control consists of 3 different levels of control solutions prepared from human whole blood.

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T E C H N .O P A T H

7.0 Comparison to the Predicate

Multichem WBT control claims to be substantially equivalent to Lyphochek® Whole Blood Immunosuppressant Controls. The controls have same/similar design and modes of operation. The key features are summarized in the following table.

Characteristics	Predicate Device:Lyphochek® Whole BloodImmunosuppressantControls	Proposed Device:Multichem WBT Controls
Similarities
Intended Use:	Lyphochek® Whole BloodImmunosuppressant - isintended for use as assayedquality control serum tomonitor the precision oflaboratory testing proceduresfor the analytes listed in thepackage insert.	Multichem WBT is intended foruse as an assayed quality controlmaterial to monitor the precisionof laboratory testing proceduresfor the analytes listed in thepackage insert.
Analytes	CyclosporineSirolimusTacrolimus	CyclosporineSirolimusTacrolimus
Differences
Form:	Lyophilized	Liquid, Frozen
Matrix:	EDTA Whole Blood	Processed Human Whole BloodHemolysate
Storage(Closed/Shelf-Life)	2 to 8°C until expiration date	30 months at -20° to -80°C
Open Vial	14 days at 2 to 8°C	Tacrolimus and Cyclosporine 10days at 2 to 8°CSirolimus 7 days at 2 to 8°C

8.0 Performance Characteristics

Traceability Summary 8.1

The analytes contained within the Multichem WBT control Level, 1, 2 and 3 were obtained from commercially available sources or are endogenous to the base

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TECHNOPATH Marrefocturing Registated in Ireland no 419288 Resuresed other as at techno-path.cc

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matrix. Technopath does not claim traceability to higher order reference materials or methods.

8.2 Value Assignment Summary

Value assignment testing was internally performed and utilized internal procedures and protocols to determine typical values that would be seen for the product across Abbott ARCHITECT i2000 chemistry system with the associated reagent test systems. For the Multichem WBT control. 2 reagent lots and 2 calibrator lots were used to incorporate reagent and calibrator variation. replicates from 16 runs were performed to give a total of 32 data points. Distinct runs, with minimum gaps of 2 hours were performed and a minimum of 8 calibration events were performed to incorporate variation from calibration and environmental sources. Value assignment ranges were established at the predetermined criteria of 30% around the grand mean to ensure that 3SD's either side of the mean were within the established range. Values for the lots tested all fell within the established ranges.

8.3 Stability Testing Summary

Stability studies have been performed to determine the open vial stability and shelf-life for this control. For open vial stability, Technopath utilized internal procedures and Isochronous - Staggered Start [Backwards / Back-ended] method from CLSI EP25A entitled "Evaluation of Stability of In Vitro Diagnostic Reagents." To minimize variation, where possible, one lot of reagent, calibrator and reference/control was used for the entire study, per analyte. Testing was performed over multiple days on 1 Abbott ARCHITECT i2000" instrument with the associated reagent test systems. All Multichem WBT analytes for open vial testing used freshly thawed vial samples that were tested in replicates of 3 at each time point. Multiple time points were tested and the point of failure was determined by the maximum allowable drift (degradation), which was determined to be 10%.

Product claims are as follows:

Open Vial Stability:

Tacrolimus and Cyclosporine 10 days at 2 to 8ºC �
Sirolimus 7 days at 2 to 8ºC .

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Fort Henry Business Park,
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E-mail: info@techno-path com

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A combination of accelerated and real-time testing was carried out utilizing CLSI EP25A in order to support a shelf-life storage claim of -20° to -80°C for 30 months. The accelerated testing utilized three lots of controls and the preliminary real-time testing utilized three lots of controls. All data was generated using the Abbott ARCHITECT i2000 instrument with the associated reagent test systems. For the Multichem WBT control, the Drift Limit was determined to be 10%. These results concluded that the Multichem WBT control product is predicted to be stable for in excess of 30 months when stored at -20°C to -80°C. The real-time testing is on-going.

Product claims are as follows:

Storage (Closed/Shelf-Life):

30 months at -20° to -80°C .

9.0 Conclusion:

The conclusions drawn from the nonclinical tests (discussed above) demonstrate that the Multichem WBT control is as safe, as effective, and performs as well as the predicate device. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

FRL Fax . . 353 10; 61 203034 UK Tel. : 44 (0) 28 30833808 UK Fox: + 44 (0) 28 30833650

TECHΝΟΡΑΤΗ

Fort Henry Business Park,
Balina, Co Tipperary, Ireland.
E-mail: infotechno-poth com

TECHNOPATH Manufacturing.
Registered in Ireland no. 419268
Registered office as above
www.techno-path.com

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

September 20, 2013

Techno-path Manufacturing Ltd. C/O Stephanie Garth. Consultant Global Compliance Plus 325 Big Elm St. HIGHLAND VILLAGE TX 75077

Re: K132174

Trade/Device Name: Multichem WBT Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I, reserved Product Code: DIF Dated: August 16, 2013 Received: August 19, 2013

Dear Ms. Garth:

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 I loase be actives that i be a betermination 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 Gevelopment and adverse overlay (2) CFR Part 820); and if applicable, the electronic form in the quality of the (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Ms. Garth

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/CDRHOffices/ycm115809.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/Medica|Devices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carol C. 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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Indications for Use Form

510(k) Number (if known):

Device Name: _ Multichem WBT

Indications for Use:

AND/OR Over-The-Counter Use Prescription Use _X (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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

Denise Johnson-lyles -S 2013.09.18 08:51:50 -04'00'

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

510(k)_k132174

Page 1 of 1

Regulation Number and Section

§ 862.3280 Clinical toxicology control material.

(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.