(89 days)
Multichem P is intended for use as a single level assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
The Multichem P control is prepared from human serum to which purified biochemical material (extracts of human origin), chemicals, drugs/preservatives and stabilizers have been added. The control is used in liquid form for convenience. This control is provided in a single level control only with twelve vials, each vial containing 3 mL.
The provided document describes the Multichem P device, which is a quality control material intended to monitor the precision of laboratory testing procedures for specific analytes. This is a Class I reserved product, meaning it is considered low risk and subject to general controls. The acceptance criteria and supporting study are primarily focused on demonstrating its performance as a stable and reliable control material.
It's important to note that this is not an AI/ML powered device, nor is it a diagnostic device that requires human interpretation of outputs. Therefore, many of the typical criteria for AI/ML or diagnostic devices (like MRMC studies, expert adjudication for ground truth, standalone performance metrics like AUC, sensitivity, specificity, etc.) are not applicable here. The "device performance" in this context refers to the stability and reliability of the control material over time and across different testing systems.
Here's a breakdown based on the provided text, addressing the requested information where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" in a quantitative performance table like for a diagnostic device. Instead, the acceptance criteria are embedded within the stability testing summary and the comparison to the predicate device. The performance is reported in terms of stability claims and value assignment.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Open Vial Stability | - 14 days at 2 to 8°C. |
| Shelf-Life Stability (Closed Vial) | - Predicted to be stable for in excess of 30 months when stored at -20℃ to -80℃. |
| Drift Limit (during stability testing) | - 10% (This was the threshold used to determine stability for the shelf-life claim). |
| Value Assignment Range Establishment | - Pre-determined criteria of 20% (Likely referring to the acceptable deviation from the target value during initial value assignment to ensure the control works across different Abbott ARCHITECT c8000 systems). |
| Substantial Equivalence to Predicate Device | - Multichem P control claims substantial equivalence to Liquichek™ Immunology Control, sharing similar intended use, form (liquid, frozen), and matrix (human serum based). Differences exist in specific assayed analytes and opened/closed vial shelf-life durations, but overall functionality as a quality control is considered equivalent. This implies that the performance (stability, ability to monitor precision) is comparable to the legally marketed predicate. |
(Note: These criteria are inferred from the description of the performance studies rather than explicitly stated as pass/fail thresholds in a table.)
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Stability Testing (Test Set):
- Accelerated Testing: Three lots of controls.
- Real-time Testing: One lot of controls.
- Initial Value Assignment: Not explicitly stated, but performed using "replicate analyses" for each specific lot. Given it's a quality control for monitoring precision, the "test set" would primarily refer to the samples used in stability studies.
- Data Provenance: Not explicitly stated regarding country of origin, but the submitter (Techno-path Manufacturing Ltd.) is based in Ireland. The testing was conducted "by the control manufacturer and/or by independent laboratories." The testing described is prospective in nature, as it involves initiating stability studies (accelerated and real-time) to generate data over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable / Not explicitly mentioned. As this is a quality control material, the "ground truth" for its performance is objective chemical stability and the ability to produce consistent results on analytical instruments, rather than a subjective interpretation by experts. "Value assignment" is based on instrumental readings and statistical methods.
4. Adjudication Method for the Test Set
- Not applicable. There is no expert adjudication process described or needed for a quality control material. The assessment is based on objective analytical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on human performance is being evaluated. Multichem P is a quality control material, not a diagnostic device with an interpretive output for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Yes, in essence, the "performance characteristics" section describes standalone performance. The device (Multichem P control) is itself the "algorithm" or material being tested. Its stability and performance are evaluated objectively on analytical systems (Abbott ARCHITECT c8000 Chemistry system) without human interpretive intervention beyond running the tests and analyzing the quantitative results. The data presented for stability is purely the performance of the control material.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this quality control material is its inherent chemical stability and the expected analyte concentration values as determined through analytical methods on specified laboratory instruments.
- For Value Assignment, the "ground truth" is the statistically determined typical value and range for each analyte on the specified instrument, established by "replicate analyses."
- For Stability Testing, the "ground truth" is the maintenance of these assigned values within predefined limits (e.g., 10% drift limit) over time and temperature conditions. This relies on objective quantitative measurements.
8. The Sample Size for the Training Set
- Not applicable in the conventional sense for an AI/ML device. This is a physical quality control material, not a software algorithm that undergoes machine learning. The term "training set" doesn't apply.
- If interpreted as "data used to initially develop and optimize the control formulation," the text doesn't provide this detail. The document describes studies to validate the manufactured product's performance.
9. How the Ground Truth for the Training Set Was Established
- Not applicable (as per point 8). There is no "training set" ground truth in the context of an AI/ML algorithm. The underlying principles for formulating such a control product would rely on established biochemical and analytical chemistry principles to ensure stability and appropriate analyte concentrations.
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510(k) Summary Multichem P
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: K131992
1.0 Submitter:
Paula McCarthy Head of Quality and Regulatory Affairs Techno-path Manufacturing Ltd. Fort Henry Business Park Ballina, Co. Tipperary Ireland Telephone: + 353 61 335844 Fax: + 353 61 203034 Email: paula.mccarthy(@techno-path.com
Submitter Contact
Stephanie G. Garth Consultant Global Compliance Plus 325 Big Elm St. Highland Village, TX 75077 Telephone: 469-230-0959 Email: globalcomplianceplus@yahoo.com
2.0 Date Submitted:
August 20, 2013
3.0 Device Identification
Proprietary Names: Multichem P Common Name: Multi-Analyte Controls, (Assayed and unassayed) Classification: Class 1, Reserved Product Code: JJY Regulation Number: 21 CFR 862.1660
· 4.0 Legally Marketed Predicate Device
| Candidate(s) | Predicate | Manufacturer | DocumentNumber |
|---|---|---|---|
| Multichem P | Liquichek™ ImmunologyControl | Bio-RadLaboratories | K022991 |
The Multichern P Control is substantially equivalent to the previously cleared Bio-Rad product listed above, currently in commercial distribution.
SEP 2 5 2013
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5.0 Device Description
The Multichem P control is prepared from human serum to which purified biochemical material (extracts of human origin), chemicals, drugs/preservatives and stabilizers have been added. The control is used in liquid form for convenience. This control is provided in a single level control only with twelve vials, each vial containing 3 mL.
The following kit configurations are available:
Multichem P (Abbott Distributed) Model 05P81-10 with Level P control: 12 vials with 3 mL contents The vial label is SP40PA
Multichem P (Technopath Distributed) Model SP41PA with Level P control; 12 vials with 3 mL contents The vial label is SP41PA
All human source material was tested and found negative by FDA approved methods for HBSAg, HCV and HIV-1/2.
6.0 Intended Use
Multichem P is intended for use as a single level assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
The following analytes are listed in the package insert:
Alpha-1 Acidglycoprotein, Alpha-1 Antitrypsin, Apolipoprotein A1 (APO A1), Apolipoprotein B (APO B), Beta-2 Microglobulin, Ceruloplasmin, Complement C3, Complement C4, C-Reactive Protein, Haptoglobin, Immunoglobulin A, Immunoglobulin G. Immunoglobulin M, Prealbumin, Rheumatoid Factor (RF), and Transferrin,
7.0 Comparison to the Predicate
Multichem P control claims to be substantially equivalent to Liquichek™ Immunology Control. The controls have same/similar design and modes of operation. The key features are summarized in the following table.
| Characteristics | Predicate Device:Liquichek™ Immunology Control:Catalog #596 | Candidate Device:Multichem P Control |
|---|---|---|
| Similarities | ||
| Intended Use: | Liquichek Immunology Control isintended for use as an assayed qualitycontrol serum to monitor the precision oflaboratory testing procedures for theanalytes listed in this package insert. | Multichem P is intended for useas a single level assayed qualitycontrol material to monitor theprecision of laboratory testingprocedures for the analytes listedin the package insert |
| Characteristics | Predicate Device:Liquichek™ Immunology Control:Catalog #596 | Candidate Device:Multichem P Control |
| Form: | Liquid, Frozen | Liquid, Frozen |
| Matrix: | Human serum based | Human serum based |
| Storage:(Closed/Shelf-Life) | -20°C to -70°Cuntil expiration date | -20°C to -80°Cuntil expiration date |
| Differences | ||
| (Opened/Shelf-life) | 30 days 2 to 8°C, except Beta-2-Microglobulin, 21 days; RheumatoidFactor, 5 days. | 14 days 2 to 8°C |
| Assayed Analytes | Contains:AdNase B (Antideoxyribonuclease-B) | Contains: |
| Albumin | ||
| Alpha 1-Antitrypsin | Alpha-1 Antitrypsin | |
| Alpha 2 Macroglobulin | ||
| Alpha-1-Acid glycoprotein | Alpha-1 Acidglycoprotein | |
| Antistreptolysin-0 | ||
| Antithrombin III (AT III) | ||
| Apolipoprotein A-1 | Apolipoprotein A1 (APO A1) | |
| Apolipoprotein B | Apolipoprotein B (APO B) | |
| Beta-2-Microglobulin | Beta-2 Microglobulin | |
| C1 Inhibitor | ||
| Ceruloplasmin | Ceruloplasmin | |
| Complement C3 | Complement C3 | |
| Complement C4 | Complement C4 | |
| Cystatin C | C-Reactive Protein | |
| C-Reactive Protein (CRP) | ||
| Ferritin | ||
| Haptoglobin | Haptoglobin | |
| IgG Subclass 1 | ||
| IgG Subclass 2 | ||
| IgG Subclass 3 | ||
| IgG Subclass 4 | ||
| Immunoglobulin A (IgA) | Immunoglobulin A | |
| Immunoglobulin E (IgE) | ||
| Immunoglobulin G (IgG) | Immunoglobulin G | |
| Immunoglobulin M (IgM) | Immunoglobulin M | |
| Kappa Light Chain | ||
| Lambda Light Chain | ||
| Lipoprotein (a) | ||
| Prealbumin | Prealbumin | |
| Protein, Total | ||
| Rheumatoid Factor | Rheumatoid Factor (RF) | |
| Transferrin | Transferrin |
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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. Value assignment ranges were established at the pre-determined criteria of 20%. The values provided in the instructions for use were derived from replicate analyses and are specific for a particular lot of product. Tests were performed by the control manufacturer and/or by independent laboratories, for various methods and instrument systems. Laboratory means may vary from the values listed during the life of the control. Values are provided only as guidelines, each laboratory should establish its own statistical limits.
Stability Testing Summary 8.2
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 protocols methods.
Product claims are as follows:
Open Vial Stability:
- . 14 days at 2 to 8°C
A combination of accelerated and preliminary real-time testing was carried out utilizing procedures and protocols 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 real-time testing utilized one lot of controls. All data was generated using the Abbott ARCHITECT c8000 Chemistry system with the associated reagent test systems. The Drift Limit was determined to be 10%. These results concluded that the Multichem P control is predicted to be stable for in excess of 30 months when stored at -20℃ to -80℃. The real-time testing is on-going.
Note: ARCHITECT and c8000 are trademarks of Abbott Laboratories.
8.3 Traceability Summary
The analytes contained within the Multichem P control were obtained from commercially available sources or endogenous components to the base serum matrix. Techno-path 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 P 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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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 25, 2013
TECHNO-PATH MANUFACTURING LTD. C/O MS. STEPHANIE G. GARTH CONSULTANT GLOBAL COMPLIANCE PLUS 325 BIG ELM ST. HIGHLAND VILLAGE TX 75077
Re: K131992
Trade/Device Name: Multichem P Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I Product Code: JJY Dated: August 20, 2013 Received: August 23, 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 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. Stephanie 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.fda.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/MedicalDcvices/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Maria M. Chan -S
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K131992
Device Name Multichem P
Indications for Use (Describe)
Multichem P is intended for use as a single level assayed quality control the precision of laboratory testing procedures for the analytes listed in the package insert.
The following analytes are listed in the package insert:
Alpha-1 Acidglycoprotein Alpha-1 Antitrypsin Apolipoprotein A1 (APO A1) Apolipoprotein B (APO B) Beta-2 Microglobulin Ceruloplasmin Complement C3 Complement C4 C-Reactive Protein Haptoglobin Immunoglobulin A Immunoglobulin G Immunoglobulin M Prealbumin Rheumatoid Factor (RF) Transferrin
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY |
|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) |
| Maria M. Chan -S |
| FORM FDA 3881 (6/13) | Page 1 of 2 | PSC Publishing Services (301) 443-6740 EF |
|---|---|---|
| ---------------------- | ------------- | ------------------------------------------- |
§ 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.