(67 days)
Not Found
No
The summary describes a quality control material for laboratory testing and does not mention any AI or ML components.
No
The device is described as an assayed quality control material used to monitor the precision of laboratory testing procedures, not to treat or diagnose patients.
No
This device is described as an "assayed quality control material" used to "monitor the precision of laboratory testing procedures." It is used to ensure the accuracy and reliability of diagnostic tests, rather than directly diagnosing a patient's condition.
No
The device is described as a "quality control material" consisting of "control solutions prepared from human whole blood." This indicates a physical, biological product, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the precision of laboratory testing procedures for the analytes listed in the package insert." This is a classic function of an IVD control material used in a laboratory setting.
- Device Description: It describes the material as "whole blood control materials prepared from human whole blood" with added substances, designed to "allow performance monitoring within the analytical range." This aligns with the definition of an IVD control.
- Performance Studies: The document details performance studies related to "Value assignment testing" and "Stability studies," which are typical evaluations for IVD products to ensure their reliability and shelf-life.
- Predicate Device: The mention of a "Predicate Device" with a K number (K072721; Lyphocheck® Whole Blood Immunosuppressant Control) strongly indicates that this device is being compared to a previously cleared IVD, a common practice in regulatory submissions for IVDs.
- Intended User / Care Setting: "laboratory testing procedures" points to a clinical laboratory setting, where IVDs are used.
All these factors collectively point to this device being an In Vitro Diagnostic product.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DIF
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.
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.
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
Laboratory testing procedures
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Traceability Summary:
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 matrix. Technopath does not claim traceability to higher order reference materials or methods.
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.
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%.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows a logo with a stylized graphic above the word "TECHNOPATH". The graphic appears to be two curved shapes, possibly wings or leaves, facing each other. The text "TECHNOPATH" is written in a simple, sans-serif font, with each letter spaced evenly apart.
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® Whole | ||
| Blood Immunosuppressant | |||
| Control | Bio-Rad | ||
| Laboratories | 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
1
Image /page/1/Picture/0 description: The image shows a logo with the word "TECHNOPATH" written in capital letters. Above the word, there is a graphic that resembles two wings or a stylized DNA strand. The letters are spaced out evenly, and the overall design appears to be for a technology or science-related company.
5.0 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.
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.
181 Tul: +353 80 61 335844 IRL Fox +353 10, 61 203034 UK Tel: + 44 103 78 30833808 UK Fos: + 44 10t 28 30833650
TECHNOPATH Fort Hero Burness Port Balina Collegemer bala
Recruited in treland no. 41 Reastmend other as abo
Image /page/1/Picture/9 description: The image contains three logos. The first logo has a geometric shape on the left and the text "NSAI" on the right. The second logo has a stylized eye shape on top and the text "Quality" and "NSAI Certified" below. The third logo has a similar eye shape on top and the text "Medical Device" and "NSAI Certified" below.
2
Image /page/2/Picture/0 description: The image shows a black and white drawing of a pair of wings. The wings are curved and have a feather-like pattern. The wings are symmetrical and appear to be in motion. The image is simple and stylized.
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 Blood
Immunosuppressant
Controls | Proposed Device:
Multichem WBT Controls |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use: | Lyphochek® Whole Blood
Immunosuppressant - is
intended for use as assayed
quality control serum to
monitor the precision of
laboratory testing procedures
for the analytes listed in the
package insert. | Multichem WBT 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. |
| Analytes | Cyclosporine
Sirolimus
Tacrolimus | Cyclosporine
Sirolimus
Tacrolimus |
| Differences | | |
| Form: | Lyophilized | Liquid, Frozen |
| Matrix: | EDTA Whole Blood | Processed Human Whole Blood
Hemolysate |
| 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 10
days at 2 to 8°C
Sirolimus 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
111 14: + 353 10) 61 335844 RL Fox: + 353 101 61 203034 UK Ta); + 44 (0) 28 30833808
UK Fos: + 44 (0) 28 30833650
TECHNOPATH Fort Henry Business Pork. Ballina, Co Traperary, belond all: info@ilachno.puth ca
TECHNOPATH Marrefocturing Registated in Ireland no 419288 Resuresed other as at techno-path.cc
3
Image /page/3/Figure/0 description: The image shows a black and white drawing of a pair of wings. The wings are curved and have a feather-like pattern. The wings are symmetrical and appear to be stylized. The image is simple and has a minimalist aesthetic.
ய C H z OPAT H -
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 .
你 Fox · · 353 101 61 703034 11K Tal. . . La (0) 28 30833808 UK For: . 44 101 28 30833650
TECHNOPΑΤΗ
Fort Henry Business Park,
Balina. Co Tipperary, heland
E-mail: info@techno-path com
4
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N OPATH -س C H
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
Image /page/4/Picture/11 description: The image contains three logos. The first logo has a geometric shape on the left and the text "NSAI" on the right. The second and third logos have a similar design, featuring a stylized eye-like symbol at the top, followed by text that includes "NSAI Certified" at the bottom. The text in the middle of the second and third logos is too small to read.
5
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.
6
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
7
Indications for Use Form
510(k) Number (if known):
Device Name: _ Multichem WBT
Indications for Use:
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.
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
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