(74 days)
Multichem IA Plus is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
The Multichem IA Plus control is prepared from human serum 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. Three levels of control are available to allow performance monitoring within the analytical range. Multichem IA Plus Level 1. Level 3 controls are available in tri-level and single level kit configurations. Individual analyte values listed in the package insert are specific for the instrument system utilized.
Here's a summary of the acceptance criteria and study information for the Multichem IA Plus device, based on the provided text:
Acceptance Criteria and Device Performance
The core of the performance evaluation for this device, a quality control (QC) material, revolves around its stability and value assignment accuracy. The established acceptance criteria are related to the stability claims (open vial and shelf-life) and the accuracy of the assigned analyte values.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Value Assignment | Not explicitly stated as a numerical threshold, but implied to be within acceptable analytical variation around a "grand mean." "Pre-determined criteria of 20% around the grand mean and expanded to 30%, if needed, to ensure that 3SD's either side of the mean were within the established range." This is a guideline for establishing the recommended range, not a specific performance metric the device had to meet in a clinical study. | Value assignment ranges were established at the pre-determined criteria of 20% around the grand mean and expanded to 30%, if needed to ensure that 3SD’s either side of the mean were within the established range. 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. |
| Open Vial Stability | All analytes stable for 10 days at 2℃ to 8℃ (tightly capped), with specific exceptions: BNP (1 hour), C-Peptide (7 days), Folate (2 days), Homocysteine (7 days), Parathyroid Hormone (4 days), Troponin I (4 days), 25-OH Vitamin D (4 days). | The device met these specified stability criteria for all listed analytes under the described storage conditions. |
| Shelf-Life Stability | Stable for 30 months when stored at -20℃ to -80℃. | A combination of accelerated and real-time testing, utilizing CLSI EP25A, concluded that the Multichem IA Plus controls are predicted to be stable for 30 months when stored at -20℃ to -80℃. Real-time testing is ongoing. |
Study Details
This document describes the regulatory submission for a quality control material and primarily focuses on demonstrating substantial equivalence to a predicate device. The performance characteristics described are related to the analytical performance of the control material itself, rather than a clinical study involving patients or diagnostic accuracy.
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Sample Size used for the test set and the data provenance:
- Value Assignment: The document mentions "replicate analyses" but does not specify the exact number of replicates or the total sample size of control material used for value assignment. It involved testing across "Abbott ARCHITECT i2000 and c8000 Chemistry systems" and by "the control manufacturer and/or by independent laboratories." No specific country of origin is mentioned for this testing, but the manufacturer is based in Ireland. The data is prospective, generated specifically for this submission.
- Stability Testing: No specific sample size (number of control vials or batches) is provided for either open-vial or shelf-life stability studies, only that "internal procedures and two protocols methods" were utilized for open-vial stability and "accelerated and real-time testing" for shelf-life, following CLSI EP25A.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the traditional sense of a diagnostic device. The "ground truth" for a quality control material refers to its assigned analyte values, established through a rigorous process of testing on calibrated laboratory instruments and methods. No human experts are described as establishing a "ground truth" for the test set in the way radiologists or pathologists would for an imaging or pathology study.
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Adjudication method for the test set:
- Not applicable. This is not a study requiring adjudication of findings to determine a ground truth.
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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 a quality control material, not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is a laboratory control material, not an algorithm. The performance evaluation is inherently "standalone" in that it assesses the chemical and physical stability and assigned values of the control material itself, independent of real patient samples or diagnostic algorithms.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For value assignment: The "ground truth" is established by running the control material on various validated analytical instruments and methods, establishing a "grand mean" for each analyte. This is an analytical 'truth' derived from laboratory measurements, not a clinical ground truth like pathology or expert consensus.
- For stability: The "ground truth" is measured analytical values over time, compared against initial values and established precision requirements.
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The sample size for the training set:
- Not applicable. This is a quality control material and does not involve machine learning algorithms requiring a training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
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510(k) Summary Multichem IA Plus
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: K132091
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: 429-230-0959
2.0 Date Submitted
August 16, 2013
3.0 Device Identification
- 3.1 Proprietary Names: Multichem IA Plus
- 3.2 Common Name: Multi-Analyte Control, All Kinds (Assayed and Unassayed)
- 3.3 Class 1, Reserved Classification:
- 3.4 Product Code: JJY
- 3.5 Regulation Number: 21 CFR 862.1660
SEP 20 2013
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| Candidate | Predicate | Manufacturer | DocumentNumber |
|---|---|---|---|
| Multichem IA Plus | Liquichek™ ImmunoassayPlus Control | Bio-RadLaboratories | K001373 |
Legally Marketed Predicate Device 4.0
The Multichem IA Plus control is substantially equivalent to the previously cleared Bio-Rad product listed above, currently in commercial distribution.
5.0 Device Description
The Multichem IA Plus control is prepared from human serum 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.
Three levels of control are available to allow performance monitoring within the analytical range. Multichem IA Plus Level 1. Level 3 controls are available in tri-level and single level kit configurations. Individual analyte values listed in the package insert are specific for the instrument system utilized.
Below are the different kit configurations:
Multichem IA Plus
Model 05P76-10 with Tri-Level controls; 4 vials of each level with 5 mL contents Model IA310A with Tri-Level controls; 4 vials of each level with 5 mL contents Model IA311A with Level 1 control: 12 vials with 5 mL contents Model IA312A with Level 2 control; 12 vials with 5 mL contents Model IA313A with Level 3 control; 12 vials with 5 mL contents
All human source material was tested and found negative by FDA approved methods for HBSAg, HCV and HIV-1/2.
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6.0 Intended Use
Multichem IA Plus control is intended for use as an assayed quality control serum 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:
Luteinizing Hormone Alpha Fetoprotein (AFP) Myoglobin Anti-thyroglobulin Phenobarbital Anti-thyroperoxidase Phenytoin BNP Progesterone CA 125 Prolactin CA 15-3 Prostate Specific Antigen, Total CA 19-9 Prostate Specific Antigen, Free Carbamazepine Parathyroid Hormone (PTH) (1-84) Carcinogenic Embryonic Antigen (CEA) Sex Hormone Binding Globulin (SHBG) CK-MB Triiodothyronine, Free (FT3) Cortisol Triiodothyronine, Total (TT3) C-Peptide T-Uptake DHEA Sulfate Thyroxine, Free (FT4) Digoxin Thyroxine, Total (TT4) Estradiol Testosterone Ferritin Theophylline Folate Thyroid Stimulating Hormone (TSH) Follicle Stimulating Hormone (FSH) Troponin I Gentamicin Valproic Acid Homocysteine Vancomycin Human Chorionic Gonadotropin (BhCG) Vitamin B.12 Immunoglobulin E 25-OH Vitamin D Insulin
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7.0 Comparison to the Predicate
Multichem IA Plus control claims to be substantially equivalent to the Liquichek™ Immunoassay Plus control. The controls have same / similar design and modes of operation. The key features are summarized in the table on the following page.
.
| Characteristics | Predicate Device:Liquichek™ Immunoassay Plus Control | Candidate Device:Multichem IA Plus Control. |
|---|---|---|
| Similarities | ||
| Intended Use: | An assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. | The Multichem IA Plus Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. |
| Form: | Frozen until useLiquid | Frozen until useLiquid |
| Matrix: | Human serum | Human serum |
| Storage(Unopened) | -20° to -70°C Until expiration date | -20° to -80°C Until expiration date |
| Differences | ||
| Thawed and Open | All analytes are stable for 14 days with the following exceptions:Folate will be 4 days and Estradiol will be 5 days | All analytes are stable for 10 days with the following exceptions:C-Peptide and Homocysteine will be 7 days; PTH Intact, Troponin I and 25OH Vitamin D will be 4 days; Folate will be 2 days; and BNP will be for 1 hour. |
| Analytes | Contains:11-Deoxycortisol17-Alpha Hydroxyprogesterone25-Hydroxy Vitamin DAcetaminophenAldosteroneAlpha Fetoprotein (AFP)AmikacinAmiodaroneAmitriptylineAndrostenedioneAngiotensin IAntithyroglobulin antibody (anti-TPO-Ab)Antithyroid Peroxidase Antibodies (anti TPO-Ab) | Contains:Alpha Fetoprotein (AFP)Anti-thyroglobulinAnti-thyroperoxidase |
| Characteristics | Predicate Device: Liquichek™Immunoassay PlusControl | Candidate Device:Multichem IA Plus Control |
| CA 125 | ||
| CA 15-3 | ||
| CA 19-9 | ||
| Caffeine | ||
| Carbamazepine | Carbamazepine | |
| Carbamazepine, Free | ||
| Carcinoembryonic Antigen (CEA) | Carcinogenic Embryonic Antigen (CEA) | |
| Chloramphenicol | ||
| CK-MB Isoenzyme | CK-MB | |
| Cortisol | Cortisol | |
| C-Peptide | ||
| Cyclosporine | ||
| Dehydroepiandrosterone (DHEA) | ||
| (1) | ||
| Dehydroepiandrosterone(DHEA)(Sulfate) | DHEA Sulfate | |
| Desipramine | ||
| Digoxin | Digoxin | |
| Disopyramide | ||
| Estradiol | Estradiol | |
| Estriol, Free | ||
| Estriol Total | ||
| Estrogen, Total | ||
| Ethosuximide | ||
| Ferritin | Ferritin | |
| Flecainide | ||
| Folate | Folate | |
| Follicle Stimulating Hormone(FSH) | Follicle Stimulating Hormone(FSH) | |
| Fructosamine | ||
| Gentamicin | Gentamicin | |
| Homocysteine | ||
| Human Chorionic Gonadotropin(hCG) | Human Chorionic Gonadotropin(BhCG) | |
| Human Chorionic Gonadotropin(hCG)-Beta Subunit | ||
| Characteristics | Predicate Device: Liquichek™Immunoassay PlusControl | Candidate Device:Multichem IA Plus Control |
| Ibuprofen | ||
| Imipramine | ||
| Immunoglobulin A (IgA) | ||
| Immunoglobulin E (IgE) | Immunoglobulin E | |
| Immunoglobulin G (IgG) | ||
| Immunoglobulin M (IgM) | ||
| Insulin | Insulin | |
| Iron | ||
| Lidocaine | ||
| Lithium | ||
| Luteinizing Hormone (LH) | Luteinizing HormoneMyoglobin | |
| N-Acetylprocainamide (NAPA) | ||
| Netilmicin | ||
| Nortriptyline | ||
| Phenobarbital | Phenobarbital | |
| Phenytoin | Phenytoin | |
| Phenytoin, Free | ||
| Primidone | ||
| Procainamide | ||
| Progesterone | Progesterone,Prolactin | |
| Prolactin | ||
| Propanolol | ||
| Prostatic Acid Phosphatase (PAP) | ||
| Prostate Specific Antigen (PSA) | Prostate Specific Antigen, Total | |
| Prostatic Specific Antigen, Free | Prostate Specific Antigen, Free | |
| (PSA, Free) | ||
| Parathyroid Hormone-MM (PTH-MM) | Parathyroid Hormone (PTH) (1-84) | |
| Quinidine | ||
| Salicylate | ||
| Sex Hormone Binding Globulin(SHBG) | Sex Hormone Binding Globulin (SHBG) | |
| Somatomedin-C | ||
| T3, Free | Triiodothyronine, Free (FT3) | |
| T3, Total | Triiodothyronine, Total (TT3) | |
| T3 Uptake/T Uptake | T-Uptake | |
| Characteristics | Predicate Device: Liquichek™Immunoassay PlusControl | Candidate Device:Multichem IA Plus Control |
| T4, FreeT4, TotalTestosteroneTestosterone FreeTheophyllineThyroglobulinThyroid Stimulating Hormone(TSH)Thyroxine Binding Globulin(TBG)TobramycinTotal Iron Binding Capacity(TIBC)Tricyclic Antidepressants Screen(TCA) | Thyroxine, Free (FT4)Thyroxine, Total (TT4)TestosteroneTheophyllineThyroid Stimulating Hormone(TSH) | |
| Valproic AcidValproic Acid, FreeVancomycinVitamin B12 | Valproic AcidVancomycinVitamin B1225-OH Vitamin D |
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8.0 Performance Characteristics
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 i2000 and c8000 Chemistry systems with the associated reagent test systems .Value assignment ranges were established at the pre-determined criteria of 20% around the grand mean and expanded to 30%, if needed to ensure that 3SD's either side of the mean were within the established range. 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
Stability studies have been performed to determine the open vial stability and shelflife for this control. For open vial stability, Techno-path utilized internal procedures and two protocols methods. Product claims are as follows:
Open Vial Stability:
Analytes are stable for 10 days after being thawed and opened when stored tightly capped at 2℃ to 8℃ with the following exceptions:
- . BNP will be stable for 1 hour
- C Peptide will be stable for 7 days .
- Folate will be stable for 2 days .
- Homocysteine will be stable for 7 days .
- . Parathyroid Hormone will be stable for 4 days
- . Troponin I will be stable for 4 days
- . 25-OH Vitamin D will be stable for 4 days
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 results concluded that the Multichem IA Plus controls are predicted to be stable for 30 months when stored at -20℃ to -80℃. The real-time testing is on-going.
Traceability Summary
The analytes contained within the Multichem IA Plus controls (Level, 1, 2 and 3) were obtained from commercially available sources or are endogenous to the base serum matrix. Techno-path does not claim traceability to higher order reference materials or methods.
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9.0 Conclusion:
.
The conclusions drawn from the nonclinical tests (discussed above) demonstrate that the Multichem IA Plus 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/9/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all capital letters. The text is in a bold, sans-serif font. The words are arranged on a single line and centered horizontally. The background is plain and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G605 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: K132091
Trade/Device Name: Multichem IA Plus Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: I, reserved Product Code: JJY 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 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 Part 801); 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 regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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/MedicalDevices/Resourcesfor You/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): _k132091
Device Name: _ Multichem IA Plus _____________________________________________________________________________________________________________________________________________
Indications for Use:
Multichem IA Plus is intended for use as an assayed quality control serum 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 Fetoprotein (AFP) | Folate | Sex Hormone Binding Globulin |
|---|---|---|
| Anti-thyroglobulin | Prostate Specific Antigen, Free | T-Uptake |
| Anti-thyroperoxidase | Follicle Stimulating Hormone (FSH) | Testosterone |
| Human Chorionic Gonadotropin (BhCG) | Triiodothyronine, Free (FT3) | Theophylline |
| BNP (1-32) | Thyroxine, Free (FT4) | Troponin I |
| CA 125 | Gentamicin | Thyroid Stimulating Hormone (TSH) |
| CA 15-3 | Homocysteine | Triiodothyronine, Total (TT3) |
| CA 19-9 | Immunoglobulin E | Thyroxine, Total (TT4) |
| Carbamazepine | Insulin | Valproic Acid |
| Carcinogenic Embryonic Antigen (CEA) | Luteinizing Hormone | Vancomycin |
| CK-MB | Myoglobin | Vitamin B12 |
| Cortisol | Parathyroid Hormone (PTH) (1-84) | 25-OH Vitamin D |
| C-Peptide | Phenobarbital | |
| DHEA-Sulfate | Phenytoin | |
| Digoxin | Progesterone | |
| Estradiol | Prolactin | |
| Ferritin | Prostate Specific Antigen, Total |
| Prescription Use X | AND/OR Over-The-Counter Use _________ |
|---|---|
| (Part 21 CFR 801 Subpart D) | (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)
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Ruth A. Chesler -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K132091 510(k)_
§ 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.