(35 days)
For in vitro diagnostic use. Verification Kits VK-3, VK-4, VK-R5, VK-R7 and VK-Crea are assayed quality control systems for calibration verification for the parameters and the analyzers listed in the insert specifying the control ranges.
VK-3 Verification Kit is a calibration verification kit consisting of the following 5 quality control solutions: Hematocrit and Metabolite QUALICHECK Level 1, S7170 (K150226), Hematocrit and Metabolite QUALICHECK Level 2, S7180 (K150226), Range+ QUALICHECK Level 1, S7930 (K130236), Range+ QUALICHECK Level 2, S7940 (K130236), Range+ QUALICHECK Level 3, S7950 (K130236). These quality control solutions have been 510(k) cleared (K150226 and K130236) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution. The Hematocrit and Metabolite QUALICHECK quality control solutions are aqueous solutions containing organic buffer, acid, salts, metabolites, and a preservative. The Range+ QUALICHECK quality control solutions are aqueous solutions containing biological buffers, salts, glucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen.
VK-4 Verification Kit is a calibration verification kit consisting of the following 4 quality control solutions: Qualicheck 5+ Level 1, S7730 (K980135), Qualicheck 5+ Level 2, S7740 (K980135), Qualicheck 5+ Level 3, S7750 (K980135), Qualicheck 5+ Level 4, S7760 (K980135). These quality control solutions have been 510(k) cleared (K980135) with an intended use which did not include calibration verification. Production of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution. The quality control solutions are agueous solutions containing biological buffers, salts, qlucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen.
VK-R5 Verification Kit is a calibration kit consisting of the following 4 quality control solutions: Range+ QUALICHECK Level 1, S7930 (K130236), Range+ QUALICHECK Level 2, S7940 (K130236), Range+ QUALICHECK Level 3, S7950 (K130236), Qualicheck 5+, Level 3, S7750, (K980135). These quality control solutions have been 510(k) cleared (K130236 and K980135) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution. The quality control solutions are agueous solutions containing biological buffers, salts, qlucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen.
VK-R7 Verification Kit is a calibration verification kit consisting of the following 4 quality control solutions: Range+ QUALICHECK Level 1, S7930 (K130236), Range+ QUALICHECK Level 2, S7940 (K130236), Range+ QUALICHECK Level 3, S7950 (K130236), High Metabolite QUALICHECK Level 1, S7570 (K130415). These quality control solutions have been 510(k) cleared (K130236 and K130415) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution. The Range+ QUALICHECK quality control solutions are aqueous solutions containing biological buffers, salts, glucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen. The High Metabolite QUALICHECK quality control solutions are aqueous solutions containing biological buffers, salts, metabolites and a preservative.
VK-Crea Verification Kit is a calibration verification kit consisting of the following 4 quality control solutions: AutoCheck6+ Level 1, S7835 (K051928), AutoCheck6+ Level 2, S7845 (K051928), AutoCheck6+ Level 3, S7855 (K051928), Cleaning Met II Solution, S8377 (K051968). These quality control solutions have been 510(k) cleared (K051928) and (K051968) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each level of AutoCheck6+ and one bottle of Cleaning Met II Solution. Each AutoCheck6+ ampoule contains 0.7 mL solution. The Cleaning Met II Solution contains 100 mL solution. The quality control solutions are aqueous solutions containing biological buffers, salts, metabolites, enzyme and a preservative. The AutoCheck6+ solutions also contain dyes and are equilibrated with carbon dioxide and oxygen.
The provided document describes the clearance of several "Verification Kits" as calibration verification materials for in vitro diagnostic use. It establishes substantial equivalence by comparing the new kits to a predicate device (Validate GC1, GC2, GC3, and GC4 Calibration Verification/Linearity Test Sets).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for the performance of the new Verification Kits. Instead, it leverages the previous 510(k) clearances of the individual components within these kits and argues that because the new kits are essentially repackaged and relabeled versions of already cleared products, their performance characteristics are maintained. The acceptance criteria essentially revolve around demonstrating that the new kits are substantially equivalent to the predicate device and that their performance (stability, storage, traceability, and value assignment) is consistent with the cleared individual components.
| Acceptance Criteria (Implied) | Reported Device Performance (as stated in document) |
|---|---|
| Substantial Equivalence: - Intended Use - Fundamental Scientific Technology - Features - Characteristics | VK-3, VK-4, VK-R5, VK-R7, VK-Crea Verification Kits: - Intended Use: "For in vitro diagnostic use. ... assayed quality control systems for calibration verification for the parameters and the analyzers listed in the insert specifying the control ranges." (Similar to predicate) - Fundamental Scientific Technology: All kits are liquid, aqueous solutions, similar to predicate. - Features: All kits are multi-analyte controls. - Characteristics: Product Code (JJY), Matrix (Aqueous primarily, predicate has human serum and aqueous), Traceability (IUPAC pH scale, NIST SRM, IFCC, SIGMA, primary analytical standards). Measurands vary but are within the scope of multi-analyte controls. |
| Stability (Shelf Life): - Maintained from individual components | VK-3, VK-4, VK-R5, VK-R7, VK-Crea Verification Kits: - Shelf life: 24 months (or 12 months for VK-Crea) as maximum, depending on oldest component. (Predicate: 12 months for all). Document states stability is "documented by reference to K150226, K130236, K980135, K130415, K051928 and K051968" (previous clearances of individual components). |
| Stability (Open Vial): - Maintained from individual components | VK-3, VK-4, VK-R5, VK-R7, VK-Crea Verification Kits: - Open vial stability: N/A, "shall be used immediately." (Predicate: 12 months). The document states that the open vial stability for the new kits is "not affected by the repackaging" implying that the lack of open vial stability is part of the established performance. |
| Storage Conditions: - Maintained from individual components | VK-3, VK-R5, VK-R7, VK-Crea: 2 °C – 8 °C. VK-4: 2 °C – 25 °C. (Predicate: 2 °C – 8 °C). Document states storage conditions are "for the most temperature sensitive component" and "documented by reference to K150226, K980135, K130415, K051928 and K051968". |
| Traceability: - Maintained from individual components | VK-3, VK-4, VK-R5, VK-R7, VK-Crea Verification Kits: - Traceable to "established international references as defined for the individual components and are unchanged." (Predicate: NIST SRM, primary analytical standards). Document states "documented by reference to K150226, K130236, K980135, K130415, K051928 and K051968". |
| Value Assignment: - Maintained from individual components | VK-3, VK-4, VK-R5, VK-R7, VK-Crea Verification Kits: - "Assigned values for each of the parameters are transferred unchanged from the labeling of the individual components to the Verification Kits." Document states "documented by reference to K150226, K130236, K980135, K130415, K051928 and K051968". |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a traditional "test set" in the context of device performance in the same way one would for a new clinical diagnostic algorithm. This submission is for an in vitro diagnostic control material that is a repackaging of existing, cleared components.
- Sample Size for Test Set: Not applicable in the conventional sense. The "test" for the new kits primarily involves demonstrating that repackaging does not alter the established performance of the individual components. The performance data for the individual components would have been provided in their respective 510(k) submissions (K150226, K130236, K980135, K130415, K051928, K051968). The current submission relies on references to these previous clearances.
- Data Provenance: The data provenance for the underlying performance of the individual components would be detailed in their original 510(k) submissions. This document implies retrospective reliance on previously cleared data. It does not mention any new prospective studies specific to the repackaged kits, beyond demonstrating that the new packaging/labeling process itself doesn't degrade the product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. The "ground truth" for calibration verification kits refers to the accurately assigned values for the analytes. This is established through rigorous analytical measurement and traceability to international standards (e.g., NIST SRM, IUPAC pH scale, IFCC, SIGMA), not by expert consensus in clinical interpretation.
4. Adjudication Method for the Test Set
This is not applicable for a calibration verification kit. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human experts are interpreting results and discrepancies need to be resolved. The "truth" for these kits is analytical.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. MRMC studies are used for evaluating the performance of imaging or other diagnostic devices where human interpretation is involved, often in comparison to an AI algorithm. The devices in question are calibration verification kits, which are chemical analytical controls. There is no human "reader" or AI involved in their direct function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The devices are physical chemical control solutions, not software algorithms.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for these calibration verification kits is analytical traceability, established through:
- Reference Materials: Traceability to NIST (National Institute of Standards and Technology) Standard Reference Materials (SRM).
- International Standards: Traceability to IUPAC pH scale, IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) standards, and SIGMA standards.
- Primary Analytical Standards: The document mentions "primary analytical standards" for the predicate device, implying similar methodologies for the SE device's components.
These methods involve precise chemical and physical measurements to assign accurate values to the analytes in the control solutions.
8. The Sample Size for the Training Set
This is not applicable. These are physical chemical control materials, not AI algorithms or models that require training data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no "training set." The ground truth for the performance parameters of the individual components of these kits was established through analytical methods and traceability as described in point 7, during their original 510(k) clearances.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 28, 2016
RADIOMETER AMERICA INC. KAREN BANG JAKOBSEN REGULATORY AFFAIRS SPECIALIST 250 S. KRAEMER BLVD BREA, CA 92821
Re: K153712
Trade/Device Name: VK-3 Verification Kit: VK-4 Verification Kit: VK-R5 Verification Kit: VK-R7 Verification Kit: VK-Crea Verification Kit Regulation Number: 21 CFR 862.1660 Regulation Name: Multi-analyte controls, all kinds (assayed) Regulatory Class: I. reserved Product Code: JJY Dated: December 21, 2015 Received: December 24, 2015
Dear Karen Bang Jakobsen:
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 (OS) 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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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/Resourcesfor You/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/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,
Katherine Serrano -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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510(k) Number: K133410
| Digital Signature Concurrence Table | |
|---|---|
| Reviewer Sign-Off | Sheila Connors/NG |
| Branch Chief Sign-Off | Yung Chan |
| Division Sign-Off |
Template Name: OIR Letter Generator v1.10 - Letter type: SE
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Indications for Use
510(k) Number (if known)
Device Name
VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit
Indications for Use (Describe)
For in vitro diagnostic use. Verification Kits VK-3, VK-4, VK-R7 and VK-Crea are assayed quality control systems for calibration verification for the parameters and the analyzers listed in the insert specifying the control ranges.
| Type of Use (Select one or both, as applicable) |
|---|
| XPrescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
1 Administative information
| Submitter | |
|---|---|
| Company Name: | Radiometer America Inc. |
| ER Number: | 3010420736 |
| Address: | 250 S. Kraemer Blvd |
| Brea, CA 92821 (USA) | |
| Phone: | 800-736-0600 |
| Fax: | 800-736-0601 |
| Contact Person | |
| Name: | Karen Bang Jakobsen |
| Function: | Regulatory Affairs Specialist |
| E-mail: | Karen.bang.jakobsen@radiometer.dk |
| Phone: | +45 3827 3827 |
| Fax: | +45 3827 2727 |
| Date prepared | |
| Date: | December 21, 2015 |
| Device Information | |
| Device Name: | VK-3 Verification Kit |
| VK-4 Verification Kit | |
| VK-R5 Verification Kit | |
| VK-R7 Verification Kit | |
| VK-Crea Verification Kit | |
| Common Name: | Calibration Verification Kit |
Classification :
| Classification name | CFR Section | Device Class | Product Code |
|---|---|---|---|
| Multi-analyte controls, all kinds(assayed) | 862.1660 | I, reserved | JJY |
2 Device Description
VK-3 Verification Kit
VK-3 Verification Kit is a calibration verification kit consisting of the following 5 quality control solutions:
- Hematocrit and Metabolite QUALICHECK Level 1, S7170 (K150226) ●
- Hematocrit and Metabolite QUALICHECK Level 2, S7180 (K150226) .
- . Range+ QUALICHECK Level 1, S7930 (K130236)
- Range+ QUALICHECK Level 2, S7940 (K130236) ●
- Range+ QUALICHECK Level 3, S7950 (K130236) ●
These quality control solutions have been 510(k) cleared (K150226 and K130236) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products.
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Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution.
The Hematocrit and Metabolite QUALICHECK quality control solutions are aqueous solutions containing organic buffer, acid, salts, metabolites, and a preservative. The Range+ QUALICHECK quality control solutions are aqueous solutions containing biological buffers, salts, glucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen.
VK-4 Verification Kit
VK-4 Verification Kit is a calibration verification kit consisting of the following 4 quality control solutions:
- Qualicheck 5+ Level 1, S7730 (K980135) ●
- Qualicheck 5+ Level 2, S7740 (K980135) ●
- Qualicheck 5+ Level 3, S7750 (K980135) .
- Qualicheck 5+ Level 4, S7760 (K980135) .
These quality control solutions have been 510(k) cleared (K980135) with an intended use which did not include calibration verification. Production of this kit consists solely in repackaging and relabeling of the already cleared products.
Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution.
The quality control solutions are agueous solutions containing biological buffers, salts, qlucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen.
VK-R5 Verification Kit
VK-R5 Verification Kit is a calibration kit consisting of the following 4 quality control solutions:
- Range+ QUALICHECK Level 1, S7930 (K130236) .
- Range+ QUALICHECK Level 2, S7940 (K130236) ●
- Range+ QUALICHECK Level 3, S7950 (K130236) ●
- Qualicheck 5+, Level 3, S7750, (K980135) .
These quality control solutions have been 510(k) cleared (K130236 and K980135) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products.
Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution.
The quality control solutions are agueous solutions containing biological buffers, salts, qlucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen.
VK-R7 Verification Kit
VK-R7 Verification Kit is a calibration verification kit consisting of the following 4 quality control solutions:
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- Range+ QUALICHECK Level 1, S7930 (K130236) ●
- Range+ QUALICHECK Level 2, S7940 (K130236) .
- . Range+ QUALICHECK Level 3, S7950 (K130236)
- High Metabolite QUALICHECK Level 1, S7570 (K130415) ●
These quality control solutions have been 510(k) cleared (K130236 and K130415) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products.
Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution.
The Range+ QUALICHECK quality control solutions are aqueous solutions containing biological buffers, salts, glucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen.
The High Metabolite QUALICHECK quality control solutions are aqueous solutions containing biological buffers, salts, metabolites and a preservative
VK-Crea Verification Kit
VK-Crea Verification Kit is a calibration verification kit consisting of the following 4 quality control solutions:
- AutoCheck6+ Level 1, S7835 (K051928) .
- AutoCheck6+ Level 2, S7845 (K051928) ●
- AutoCheck6+ Level 3, S7855 (K051928) ●
- Cleaning Met II Solution, S8377 (K051968)
These quality control solutions have been 510(k) cleared (K051928) and (K051968) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products.
Each kit consists of 4 ampoules of each level of AutoCheck6+ and one bottle of Cleaning Met II Solution. Each AutoCheck6+ ampoule contains 0.7 mL solution. The Cleaning Met II Solution contains 100 mL solution.
The quality control solutions are aqueous solutions containing biological buffers, salts, metabolites, enzyme and a preservative. The AutoCheck6+ solutions also contain dyes and are equilibrated with carbon dioxide and oxygen.
3 Purpose of submission
To seek clearance of five calibration verification kits based on already cleared quality control solutions.
4 Intended Use/Indications for use
For in vitro diagnostic use. Verification Kits VK-3, VK-4, VK-R5, VK-R7 and VK-Crea are assayed quality control systems for calibration verification for the parameters and the analyzers listed in the insert specifying the control ranges.
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5 Predicate device
Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test Sets (K091225)
6 Substantial Equivalence
All five Verification Kits are substantially equivalent in intended use, fundamental scientific technology, features, and characteristics to the predicate device:
510(k) Number; Name; Device Manufacturer:
K091225; Validate GC1 Calibration Verification/Linearity Test Set; Validate GC2 Calibration Verification/Linearity Test Set; Validate GC3 Calibration Verification/Linearity Test Set; Validate GC4 Calibration Verification/Linearity Test Set Maine Standards Co.
| Similarities | ||
|---|---|---|
| Issue | SE Device (VK-3 VerificationKit) | Predicate Device (K091225) |
| Intended Use | For in vitro diagnostic use.Verification Kits VK-3, VK-4, VK-R5, VK-R7 and VK-Crea areassayed quality control systemsfor calibration verification for theparameters and the analyzerslisted in the insert specifying thecontrol ranges. | Validate GC1, GC2, GC3 and GC4Calibration Verification/Linearity TestSets are intended for in vitrodiagnostic use in the quantitativedetermination of linearity, calibrationverification and verification ofreportable range in automated, semiautomated, and manual chemistrysystems. See attached PackageInsert labeling for all analytesclaimed. |
| Product code | JJY (Multi-analyte controls, allkinds (assayed)) | JJY (Multi-analyte controls, all kinds(assayed)) |
| Form | Liquid | Liquid |
| Matrix | Aqueous | GC1: Human serumGC2: AqueousGC3: Human serumGC4: Human serum |
| Traceability | IUPAC pH scale, NIST SRM, IECC | NIST SRM, primary analyticalstandards |
VK-3 Verification Kit
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| Similarities | ||
|---|---|---|
| Issue | SE Device (VK-3 VerificationKit) | Predicate Device (K091225) |
| Measurands | pH, pCO2, pO2, cK+, cNa+,cCa2+, cCl-, cGlu and Hct | GC1: Albumin (ALB), Blood UreaNitrogen (BUN), Calcium (CA),Chloride (CL), Cholesterol (CHOL),Creatinine (CREA), Glucose (GLU),Potassium (K), Lactate (LAC),Lithium (LITH), Magnesium (MG),Sodium (NA), Phosphorous (PHOS),Total Protein (TP), Triglycerides(TRIG), and Uric Acid (UA)GC2: Ammonia (NH3), CarbonDioxide (CO2), Ethanol (ETOH), andIron (FE)GC3: Alkaline Phosphatase (ALP),Alanine Aminotransferase (ALT),Amylase (AMY), AspartateAminotransferase (AST), CreatineKinase (CK), Gamma-GlutamylTransferase (GGT), LactateDehydrogenase (LD) and Lipase(LIP)GC4: Direct Bilirubin (DBIL) andTotal Bilirubin (TBIL) |
| Storage | 2 - 8 °C | 2 – 8 °C |
| Differences | ||
|---|---|---|
| Issue | SE Device (VK-3 VerificationKit) | Predicate Device (K091225) |
| Shelf life | 24 months (as a maximum,depending on the remaining shelflife of the oldest component) | 12 months |
| Open vial stability | N/A, shall be used immediately | 12 months |
| Levels | 3 (2 levels for Hct) | 6 |
| Similarities | ||
| Issue | SE Device (VK-4 VerificationKit) | Predicate Device (K091225) |
| Intended Use | For in vitro diagnostic use.Verification Kits VK-3, VK-4, VK-R5, VK-R7 and VK-Crea areassayed quality control systemsfor calibration verification for theparameters and the analyzerslisted in the insert specifying the | Validate GC1, GC2, GC3 and GC4Calibration Verification/Linearity TestSets are intended for in vitrodiagnostic use in the quantitativedetermination of linearity, calibrationverification and verification ofreportable range in automated, semiautomated, and manual chemistrysystems. See attached PackageInsert labeling for all analytesclaimed. |
| Product code | JJY (Multi-analyte controls, allkinds (assayed)) | JJY (Multi-analyte controls, all kinds(assayed)) |
| Form | Liquid | Liquid |
| Matrix | Aqueous | GC1: Human serumGC2: AqueousGC3: Human serumGC4: Human serum |
| Traceability | IUPAC pH scale, NIST SRM | NIST SRM, primary analyticalstandards |
| Measurands | pH, pCO2, pO2 | GC1: Albumin (ALB), Blood UreaNitrogen (BUN), Calcium (CA),Chloride (CL), Cholesterol (CHOL),Creatinine (CREA), Glucose (GLU),Potassium (K), Lactate (LAC),Lithium (LITH), Magnesium (MG),Sodium (NA), Phosphorous (PHOS),Total Protein (TP), Triglycerides(TRIG), and Uric Acid (UA) |
| GC2: Ammonia (NH3), CarbonDioxide (CO2), Ethanol (ETOH), andIron (FE) | ||
| GC3: Alkaline Phosphatase (ALP),Alanine Aminotransferase (ALT),Amylase (AMY), AspartateAminotransferase (AST), CreatineKinase (CK), Gamma-GlutamylTransferase (GGT), LactateDehydrogenase (LD) and Lipase(LIP) | ||
| GC4: Direct Bilirubin (DBIL) andTotal Bilirubin (TBIL) | ||
| Differences | ||
| Issue | SE Device (VK-4 VerificationKit) | Predicate Device (K091225) |
| Storage | 2 - 25 °C | 2 – 8 °C |
| Shelf life | 24 months (as a maximum,depending on the remaining shelflife of the oldest component) | 12 months |
| Open vial stability | N/A, shall be used immediately | 12 months |
| Levels | 4 | 6 |
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VK-4 Verification Kit
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VK-R5 Verification Kit
| Similarities | ||
|---|---|---|
| Issue | SE Device (VK-R5 VerificationKit) | Predicate Device (K091225) |
| Intended Use | For in vitro diagnostic use.Verification Kits VK-3, VK-4, VK-R5, VK-R7 and VK-Crea areassayed quality control systemsfor calibration verification for theparameters and the analyzerslisted in the insert specifying thecontrol ranges. | Validate GC1, GC2, GC3 and GC4Calibration Verification/Linearity TestSets are intended for in vitrodiagnostic use in the quantitativedetermination of linearity, calibrationverification and verification ofreportable range in automated, semiautomated, and manual chemistrysystems. See attached PackageInsert labeling for all analytesclaimed. |
| Product code | JJY (Multi-analyte controls, allkinds (assayed)) | JJY (Multi-analyte controls, all kinds(assayed)) |
| Form | Liquid | Liquid |
| Matrix | Aqueous | GC1: Human serumGC2: AqueousGC3: Human serumGC4: Human serum |
| Traceability | IUPAC pH scale, NIST SRM, IFCC,SIGMA | NIST SRM, primary analyticalstandards |
{11}------------------------------------------------
| Similarities | ||
|---|---|---|
| Issue | SE Device (VK-R5 VerificationKit) | Predicate Device (K091225) |
| Measurands | pH, pCO2, pO2, cK+, cNa+,cCa2+, cCl-, cGlu, cLac, ctHb,sO2, FO2Hb, FCOHb, FMetHb,FHbF and ctBil | GC1: Albumin (ALB), Blood UreaNitrogen (BUN), Calcium (CA),Chloride (CL), Cholesterol (CHOL),Creatinine (CREA), Glucose (GLU),Potassium (K), Lactate (LAC),Lithium (LITH), Magnesium (MG),Sodium (NA), Phosphorous (PHOS),Total Protein (TP), Triglycerides(TRIG), and Uric Acid (UA)GC2: Ammonia (NH3), CarbonDioxide (CO2), Ethanol (ETOH), andIron (FE)GC3: Alkaline Phosphatase (ALP),Alanine Aminotransferase (ALT),Amylase (AMY), AspartateAminotransferase (AST), CreatineKinase (CK), Gamma-GlutamylTransferase (GGT), LactateDehydrogenase (LD) and Lipase(LIP)GC4: Direct Bilirubin (DBIL) andTotal Bilirubin (TBIL) |
| Storage | 2 - 8 °C | 2 - 8 °C |
| Differences | ||
|---|---|---|
| Issue | SE Device (VK-R5 VerificationKit) | Predicate Device (K091225) |
| Shelf life | 24 months (as a maximum,depending on the remaining shelflife of the oldest component) | 12 months |
| Open vial stability | N/A, shall be used immediately | 12 months |
| Levels | 3 (4 levels for Glu) | 6 |
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VK-R7 Verification Kit
| Similarities | ||
|---|---|---|
| Issue | SE Device (VK-R7 VerificationKit) | Predicate Device (K091225) |
| Intended Use | For in vitro diagnostic use.Verification Kits VK-3, VK-4, VK-R5, VK-R7 and VK-Crea areassayed quality control systemsfor calibration verification for theparameters and the analyzerslisted in the insert specifying thecontrol ranges. | Validate GC1, GC2, GC3 and GC4Calibration Verification/Linearity TestSets are intended for in vitrodiagnostic use in the quantitativedetermination of linearity, calibrationverification and verification ofreportable range in automated, semiautomated, and manual chemistrysystems. See attached PackageInsert labeling for all analytesclaimed. |
| Product code | JJY (Multi-analyte controls, allkinds (assayed)) | JJY (Multi-analyte controls, all kinds(assayed)) |
| Form | Liquid | Liquid |
| Matrix | Aqueous | GC1: Human serumGC2: AqueousGC3: Human serumGC4: Human serum |
| Traceability | IUPAC pH scale, NIST SRM,SIGMA, IFCC | NIST SRM, primary analyticalstandards |
| Measurands | pH, pCO2, pO2, cK+, cNa+,cCa2+, cCl-, cGlu, cLac, ctHb,sO2, FO2Hb, FCOHb, FMetHb,FHbF and ctBil | GC1: Albumin (ALB), Blood UreaNitrogen (BUN), Calcium (CA),Chloride (CL), Cholesterol (CHOL),Creatinine (CREA), Glucose (GLU),Potassium (K), Lactate (LAC),Lithium (LITH), Magnesium (MG),Sodium (NA), Phosphorous (PHOS),Total Protein (TP), Triglycerides(TRIG), and Uric Acid (UA)GC2: Ammonia (NH3), CarbonDioxide (CO2), Ethanol (ETOH), andIron (FE)GC3: Alkaline Phosphatase (ALP),Alanine Aminotransferase (ALT),Amylase (AMY), AspartateAminotransferase (AST), CreatineKinase (CK), Gamma-GlutamylTransferase (GGT), LactateDehydrogenase (LD) and Lipase(LIP)GC4: Direct Bilirubin (DBIL) andTotal Bilirubin (TBIL) |
| Storage | 2 - 8 °C | 2 - 8 °C |
| Differences | ||
| Issue | SE Device (VK-R7 VerificationKit) | Predicate Device (K091225) |
| Shelf life | 24 months (as a maximum,depending on the remaining shelflife of the oldest component) | 12 months |
| Open vial stability | N/A, shall be used immediately | 12 months |
| Levels | 3 (4 levels for pO2 and ctHb) | 6 |
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VK-Crea Verification Kit
| Similarities | ||
|---|---|---|
| Issue | SE Device (VK-CreaVerification Kit) | Predicate Device (K091225) |
| Intended Use | For in vitro diagnostic use.Verification Kits VK-3, VK-4, VK-R5, VK-R7 and VK-Crea areassayed quality control systemsfor calibration verification for theparameters and the analyzerslisted in the insert specifying thecontrol ranges. | Validate GC1, GC2, GC3 and GC4Calibration Verification/Linearity TestSets are intended for in vitrodiagnostic use in the quantitativedetermination of linearity, calibrationverification and verification ofreportable range in automated, semiautomated, and manual chemistrysystems. See attached PackageInsert labeling for all analytesclaimed. |
| Product code | JJY (Multi-analyte controls, allkinds (assayed)) | JJY (Multi-analyte controls, all kinds(assayed)) |
| Form | Liquid | Liquid |
| Matrix | Aqueous | GC1: Human serumGC2: AqueousGC3: Human serumGC4: Human serum |
| Traceability | NIST SRM | NIST SRM, primary analyticalstandards |
{14}------------------------------------------------
| Similarities | ||
|---|---|---|
| Issue | SE Device (VK-CreaVerification Kit) | Predicate Device (K091225) |
| Measurands | cCrea | GC1: Albumin (ALB), Blood UreaNitrogen (BUN), Calcium (CA),Chloride (CL), Cholesterol (CHOL),Creatinine (CREA), Glucose (GLU),Potassium (K), Lactate (LAC),Lithium (LITH), Magnesium (MG),Sodium (NA), Phosphorous (PHOS),Total Protein (TP), Triglycerides(TRIG), and Uric Acid (UA)GC2: Ammonia (NH3), CarbonDioxide (CO2), Ethanol (ETOH), andIron (FE)GC3: Alkaline Phosphatase (ALP),Alanine Aminotransferase (ALT),Amylase (AMY), AspartateAminotransferase (AST), CreatineKinase (CK), Gamma-GlutamylTransferase (GGT), LactateDehydrogenase (LD) and Lipase(LIP)GC4: Direct Bilirubin (DBIL) andTotal Bilirubin (TBIL) |
| Storage | 2 - 8 °C | 2 - 8 °C |
| Shelf life | 12 months (as a maximum,depending on the remaining shelflife of the oldest component) | 12 months |
| Differences | ||
|---|---|---|
| Issue | SE Device (VK-CreaVerification Kit) | Predicate Device (K091225) |
| Open vial stability | N/A, shall be used immediately | 12 months |
| Levels | 4 | 6 |
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7 Performance Characteristics
7.1 Stability
The expiration date of a specific kit is defined as the earliest of the expiration dates for the individual components of the kit as specified in the labeling for the components. Since the stability is not affected by the repackaging, the stability is documented by reference to K150226, K130236, K980135, K130415, K051928 and K051968.
7.2 Storage
The storage conditions for the kits are the storage conditions for the most temperature sensitive component in the kits as specified in the labeling for the components. Storage conditions are 2 °C – 8 °C for VK-3, VK-R5, VK-R7 and VK-Crea. Storage conditions are 2 °C – 25 °C for VK-4. Since the stability is not affected by the repackaging, the stability and storage conditions are documented by reference to K150226, K980135, K130415, K051928 and K051968.
7.3 Traceability
The assigned values for each of the parameters are traceable to established international references as defined for the individual components and are unchanged. Since the value assignment and traceability are not affected by the repackaging, the traceability is documented by reference to K150226, K130236, K980135, K130415, K051928 and K051968.
7.4 Value assignment
The assigned values for each of the parameters are transferred unchanged from the labeling of the individual components to the Verification Kits. Since the value assignment is not affected by the repackaging, the value assignment is documented by reference to K150226, K130236, K980135, K130415, K051928 and K051968.
8 Conclusion
The Verification Kits (listed below) are substantially equivalent in intended use, fundamental scientific technology, features, and characteristics to the predicate device Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test Set (K091225).
Verification Kits included in this 510(k):
- VK-3 Verification Kit -
- । VK-4 Verification Kit
- -VK-R5 Verification Kit
- -VK-R7 Verification Kit
- -VK-Crea Verification Kit
§ 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.