(109 days)
Multichem U is intended for use as an assayed urine quality control to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. Two levels of Controls (Level 1 and Level 2) are supplied in liquid form.
Technopath has developed two levels of a urine control prepared from human urine to which purified biochemical material (extracts of human and animal origin), chemicals, drugs/preservatives and stabilizers have been added. The control is used in liquid form for convenience. The two levels of control are available to allow performance monitoring within the analytical range.
The following kit configurations are available:
Model UC 201A.10 with Level 1 control; 15 vials with 10 mL contents
Model UC 202A.10 with Level 2 control; 15 vials with 10 mL contents
Model 05P80-10, with Bi-Level controls; 6 Level 1 vials and 6 Level 2 vials; vials have 5mL contents
The provided 510(k) summary for Multichem U describes a quality control material and focuses on its substantial equivalence to a predicate device rather than presenting formal acceptance criteria and a study proving the device meets those criteria in the typical sense of a diagnostic or therapeutic device. Quality control materials are evaluated differently.
However, I can extract the relevant performance characteristics and the "studies" (which are more accurately "testing protocols" for QC materials) that demonstrate the device performs as intended for its stated use.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For a quality control material, "acceptance criteria" revolve around its stability, value assignment, and consistent performance across different reagent lots and calibrator lots. The "reported device performance" demonstrates that these characteristics were met.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Value Assignment Ranges: Establish appropriate ranges for each analyte to monitor precision of laboratory testing procedures. | Value assignment ranges were established at 20% around the grand mean for most analytes. A 10% range was applied to Potassium, Sodium, and Chloride. This demonstrates that target values and acceptable ranges for variation were successfully determined for all listed analytes. |
| Open Vial Stability: Maintain performance for a defined period after opening. | 30 days at 2°C - 8°C was confirmed. "point of failure was determined by the maximum allowable drift (degradation), which was determined to be analyte specific." |
| Shelf-Life Stability (Closed Vial): Maintain performance for a defined period when stored unopened. | Accelerated testing utilizing CLSI EP25A supported a shelf-life storage claim of 24 months at 2°C - 8°C. The Drift Limit was determined to be 10%. "These results concluded that the Multichem U Controls product is predicted to be stable for in excess of 24 months." Real-time testing is ongoing. |
| Compatibility with Reagent/Calibrator Variation: Performance should be consistent across different lots of reagents and calibrators. | For value assignment, 2 reagent lots and 2 calibrator lots were used to incorporate reagent and calibrator variation. This demonstrates the control's ability to provide stable results despite expected variations in other laboratory consumables. |
| Robustness to Operational/Environmental Variation: Performance should be consistent across different runs and calibration events. | For value assignment, 16 runs with 2 replicates each (total of 32 data points), with minimum gaps of 2 hours, were performed. A minimum of 8 calibration events were performed to incorporate variation from calibration and environmental sources. This indicates the control's consistent performance under typical laboratory operating conditions. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Value Assignment: For each analyte, 2 replicates from 16 runs were performed, yielding a total of 32 data points.
- Sample Size for Stability Testing:
- Open Vial: Replicates of 3 were tested at each time point.
- Shelf-Life (Accelerated): Three lots of controls were used.
- Data Provenance: Not explicitly detailed regarding "country of origin for the data" for the internal studies. However, the manufacturer is Technopath from Ireland, and the contact is in the US (Global Compliance Plus). The serum used as a base material was tested using "United States Food and Drug Administration (FDA) approved methods." The studies were conducted internally by Technopath. All testing was performed on Abbott ARCHITECT c8000 clinical chemistry systems. The studies are prospective in the sense that they were designed and executed to determine the specific performance characteristics of the Multichem U product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable in the traditional sense for a quality control material.
- Ground truth for QC materials is not established by human experts interpreting clinical cases. Instead, the "truth" (or target value) for an analyte in a QC material is determined through value assignment protocols using reference methods or well-calibrated laboratory instruments.
- The "experts" involved would be trained laboratory personnel and chemists following established protocols for analytical testing and possibly statisticians for data analysis, but not "radiologists with 10 years of experience" as one might see for an AI diagnostic device.
4. Adjudication Method for the Test Set
This section is not applicable.
- Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert interpretations of clinical data (e.g., medical images, pathology slides) to establish a gold standard.
- For quality control materials, the "truth" is determined by precise analytical measurement, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done.
- This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret cases (e.g., medical images) with and without the assistance of an AI algorithm.
- Multichem U is a quality control material used to assess the precision of laboratory instruments; it does not involve human interpretation of clinical "cases" in a way that would be assisted by an AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done.
- This concept is also relevant for AI/ML-driven diagnostic devices.
- Multichem U is a physical reagent used in conjunction with laboratory instrumentation; it is not an algorithm, and therefore, an "algorithm only" performance study is not applicable.
7. The Type of Ground Truth Used
For Multichem U, the "ground truth" for the analyte concentrations is established through value assignment testing protocols using calibrated laboratory instruments (Abbott ARCHITECT c8000 clinical chemistry systems) and associated reagent test systems.
- It is not expert consensus, pathology, or outcomes data. It's direct analytical measurement following validated procedures.
- The document states: "Value assignment testing was performed utilizing internal procedures and protocols to determine typical values that would be seen for the product..."
8. The Sample Size for the Training Set
This section is not applicable in the context of Multichem U.
- "Training set" refers to data used to train machine learning models.
- Multichem U is a physical quality control material, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the reasons stated above. As there is no training set, there is no ground truth for a training set.
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510(k) Summary Multichem U
OCT 1 5 2013
1.0 Submitter and Contact:
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
Stephanie Garth Quality and Regulatory Affairs Consultant Global Compliance Plus 325 Big Elm St. Highland Village, TX 75077 Telephone: 469 230 0959 Email: sgarth@globalcomplianceplus.com
2.0 Date Submitted:
June 28, 2013
3.0 Device Identification
Proprietary Names: Common Name: Classification: Product Code: JJY Regulation Number:
Multichem U Multi-Analyte Controls, (Assayed and unassayed) Class 1, Reserved 21 CFR 862.1660
4.0 Legally Marketed Predicate Device
| - Candidate(s) | Predicate | Manufacturer | Document. Number |
|---|---|---|---|
| Multichem U | Liquichek TM Urine ChemistryControl | Bio-RadLaboratories | K020817 |
The Multichem U Control is substantially equivalent to the Bio-Rad product listed above, currently in commercial distribution.
5.0 Device Description
Technopath has developed two levels of a urine control prepared from human urine to which purified biochemical material (extracts of human and animal origin), chemicals, drugs/preservatives and stabilizers have been added. The control is used in liquid form for convenience. The two levels of control are available to allow performance monitoring within the analytical range.
The following kit configurations are available:
Model UC 201A.10 with Level 1 control; 15 vials with 10 mL contents Model UC 202A.10 with Level 2 control; 15 vials with 10 mL contents Model 05P80-10, with Bi-Level controls; 6 Level 1 vials and 6 Level 2 vials; vials have 5mL contents
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The serum from each donor contributing urine for this material has been 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.
6.0 Intended Use
Multichem U is intended for use as an assayed urine quality control to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. Two levels of Controls (Level 1 and Level 2) are supplied in liquid form.
The following analytes are listed in the package insert: Amylase, Calcium, Chloride, Creatinine Enzymatic, Creatinine Picrate, Glucose, Magnesium, Microalbumin, Phosphorous, Potassium, Sodium, Urea Nitrogen, Uric Acid, and Urinary Protein.
7.0 Comparison to the Predicate
Multichem U control claims to be substantially equivalent to Liquichek™ Urine Chemistry Control. The control has same/similar design and modes of operation. The key features are summarized in the following table.
| Characteristics: | Predicate Device: LiquichekTMUrine Chemistry | Proposed Device: | |||
|---|---|---|---|---|---|
| Control | : Multichem U | ||||
| Similarities | |||||
| Intended Use: | Liquichek™ Urine ChemistryControl is intended for use as anassayed quality control urine tomonitor the precision of laboratoryprocedures listed in the packageinsert. | Multichem U is intended for use as anassayed urine quality control to monitorthe precision of laboratory testingprocedures for the analytes listed in thepackage insert. Two levels of Controls(Level 1 and Level 2) are supplied inliquid form. | |||
| Form: | Liquid | Liquid | |||
| Matrix: | Human urine based | Human urine based | |||
| Storage(Closed/Shelf-Life) | 2° to 8°C Until expiration date | 2° to 8°C Until expiration date | |||
| Open Vial | 30 days at 2° to 8°C | 30 days at 2° to 8°C | |||
| Differences | |||||
| Analytes(Assayed) | Contains:AmylaseCalciumChlorideCortisolCreatinine | Contains:AmylaseCalciumChlorideCreatinine EnzymaticCreatinine Picrate |
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| Characteristics | Predicate Device: Liquichek™ Urine Chemistry Control | Proposed Device: Multichem U |
|---|---|---|
| Glucose | Glucose | |
| hCG (Qualitative) | ||
| Magnesium | Magnesium | |
| Microalbumin | Microalbumin | |
| Osmolality | ||
| pH | ||
| Phosphorus | Phosphorous | |
| Potassium | Potassium | |
| Pregnancy | ||
| Protein-Total | ||
| Sodium | Sodium | |
| Specific Gravity | ||
| Urea | ||
| Urea Nitrogen | Urea Nitrogen | |
| Uric Acid | Uric Acid | |
| Urinary Protein |
8.0 Performance Characteristics
8.1 Value Assignment Summary
Value assignment testing was performed utilizing internal procedures and protocols to determine typical values that would be seen for the product across Abbott ARCHITECT c8000 clinical chemistry systems with the associated reagent test systems: For the Multichem U control, 2 reagent lots and 2 calibrator lots were used to incorporate reagent and calibrator variation where available. 2 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 pre-determined criteria of 20% around the grand mean to most analytes; however, a 10% range is applied to the Potassium, Sodium and Chloride.
8.2 Stability Testing Summary
Stability studies have been performed to determine the open vial stability and shelf-life for this For open vial stability, Technopath utilized internal procedures and two protocols control. methods (Classical [Forward] method and Isochronous - Staggered Start [Backwards / Backended] method) from CLSI EP25A entitled "Evaluation of Stability of In Virro 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 c8000 clinical chemistry system with the associated reagent test systems. All Multichem U analytes from open vial and freshly thawed vial samples were tested in replicates of 3 at each time points were tested and the point of failure was determined by the maximum allowable drift (degradation), which was determined to be analyte specific.
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Product claims are as follows:
Open Vial Stability: 30 days at 2° - 8°C
Accelerated testing was carried out utilizing CLSI EP25A in order to support a shelf-life storage claim of 24 months at 2° to 8°C. The accelerated testing utilized three lots of controls. All data was generated using the Abbott ARCHITECT c8000 clinical chemistry system with the associated reagent test systems. For the Multichem U control, the Drift Limit was determined to be 10%. These results concluded that the Multichem U Controls product is predicted to be stable for in excess of 24 months when stored at 2° - 8° C. The real-time testing is not available at this time, but is on-going and will be performed on a minimum of 3 lots.
8.3 Traceability Summary
The analytes contained within the Multichem U control (Level 1 and 2) are found endogenously in the base urine matrix and are adjusted to the required concentration through use of commercially available sources. Technopath does not claim traceability to higher order reference materials or methods.
9.0 Conclusion:
The conclusions drawn from the nonclinical tests (discussed above) demonstrate that the Multichem U 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
October 15, 2013
Techno-Path Manufacturing Ltd. C/O Stephanie Garth Global Compliance Plus 325 Big Elm St. HIGHLAND VILLAGE TX 75077
Re: K131993
Trade/Device Name: Multichem U Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, reserved Product Code: JJY Dated: August 23, 2013 Received: August 26, 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, Orug 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 provisiopp of the I 11 The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbrandi, wand adulteration. Please note: CDRH does not evaluate information related to contractly and warranties. We remind you, however, that device labeling must be truthful and not mislerading.
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 cevile can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA over publish further announcements conceming 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); 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-Ms. Garth
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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/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): K131993
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
: . .. .
Multichem U is intended for use as an assayed urine quality control to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. Two levels of Controls (Level 1 and Level 2) are supplied in liquid form.
The following analytes are listed in the package insert:
- · Amylase
- · Calcium
- Chloride .
- · Creatinine Enzymatic
- Creatinine Picrate .
- · Glucose
- Magnesium
- · Microalbumin .
- Phosphorous
- · Potassium
- · Sodium
- · Urea Nitrogen
-
- Uric Acid
- . Urinary Protein
| 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 Diagnostics and Radiological Health (OIR)
Yung W. Chan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k):K131993
Page 1 of _ 1 _
§ 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.