(35 days)
No
The device description and intended use clearly state that this is a calibration verification kit consisting of repackaged and relabeled quality control solutions. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No
The device is described as "For in vitro diagnostic use" and functions as a “calibration verification” kit for analytical instruments, not for diagnosing or treating a disease or condition.
No
The device is described as "calibration verification kits" and quality control solutions for in vitro diagnostic use, meaning they are used to ensure that diagnostic equipment (analyzers) are working correctly, rather than directly diagnosing patients.
No
The device description clearly states that the device consists of physical quality control solutions in ampoules and bottles, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use."
Furthermore, the description of the device as "assayed quality control systems for calibration verification for the parameters and the analyzers listed in the insert specifying the control ranges" clearly indicates its use in a laboratory setting to assess the performance of diagnostic instruments. This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
JJY
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.
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:
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K150226, K130236, K980135, K130415, K051928, K051968
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1660 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure composed of three overlapping profiles facing to the right. The profiles are rendered in black and appear to be connected, creating a sense of unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.
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.
1
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
2
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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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4
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.
5
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:
6
- 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.
7
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 Verification | |
| Kit) | Predicate Device (K091225) | |
| Intended 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. | Validate GC1, GC2, GC3 and GC4 | |
| Calibration Verification/Linearity Test | ||
| Sets are intended for in vitro | ||
| diagnostic use in the quantitative | ||
| determination of linearity, calibration | ||
| verification and verification of | ||
| reportable range in automated, semi | ||
| automated, and manual chemistry | ||
| systems. See attached Package | ||
| Insert labeling for all analytes | ||
| claimed. | ||
| Product code | JJY (Multi-analyte controls, all | |
| kinds (assayed)) | JJY (Multi-analyte controls, all kinds | |
| (assayed)) | ||
| Form | Liquid | Liquid |
| Matrix | Aqueous | GC1: Human serum |
| GC2: Aqueous | ||
| GC3: Human serum | ||
| GC4: Human serum | ||
| Traceability | IUPAC pH scale, NIST SRM, IECC | NIST SRM, primary analytical |
| standards |
VK-3 Verification Kit
8
| Similarities | ||
|---|---|---|
| Issue | SE Device (VK-3 Verification | |
| Kit) | Predicate Device (K091225) | |
| Measurands | pH, pCO2, pO2, cK+, cNa+, | |
| cCa2+, cCl-, cGlu and Hct | GC1: Albumin (ALB), Blood Urea | |
| Nitrogen (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), Carbon | ||
| Dioxide (CO2), Ethanol (ETOH), and | ||
| Iron (FE) | ||
| GC3: Alkaline Phosphatase (ALP), | ||
| Alanine Aminotransferase (ALT), | ||
| Amylase (AMY), Aspartate | ||
| Aminotransferase (AST), Creatine | ||
| Kinase (CK), Gamma-Glutamyl | ||
| Transferase (GGT), Lactate | ||
| Dehydrogenase (LD) and Lipase | ||
| (LIP) | ||
| GC4: Direct Bilirubin (DBIL) and | ||
| Total Bilirubin (TBIL) | ||
| Storage | 2 - 8 °C | 2 – 8 °C |
| Differences | ||
|---|---|---|
| Issue | SE Device (VK-3 Verification | |
| Kit) | Predicate Device (K091225) | |
| Shelf life | 24 months (as a maximum, | |
| depending on the remaining shelf | ||
| life 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 Verification | |
| Kit) | Predicate Device (K091225) | |
| Intended 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 | ||
| Validate GC1, GC2, GC3 and GC4 | ||
| Calibration Verification/Linearity Test | ||
| Sets are intended for in vitro | ||
| diagnostic use in the quantitative | ||
| determination of linearity, calibration | ||
| verification and verification of | ||
| reportable range in automated, semi | ||
| automated, and manual chemistry | ||
| systems. See attached Package | ||
| Insert labeling for all analytes | ||
| claimed. | ||
| Product code | JJY (Multi-analyte controls, all | |
| kinds (assayed)) | JJY (Multi-analyte controls, all kinds | |
| (assayed)) | ||
| Form | Liquid | Liquid |
| Matrix | Aqueous | GC1: Human serum |
| GC2: Aqueous | ||
| GC3: Human serum | ||
| GC4: Human serum | ||
| Traceability | IUPAC pH scale, NIST SRM | NIST SRM, primary analytical |
| standards | ||
| Measurands | pH, pCO2, pO2 | GC1: Albumin (ALB), Blood Urea |
| Nitrogen (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), Carbon | ||
| Dioxide (CO2), Ethanol (ETOH), and | ||
| Iron (FE) | ||
| GC3: Alkaline Phosphatase (ALP), | ||
| Alanine Aminotransferase (ALT), | ||
| Amylase (AMY), Aspartate | ||
| Aminotransferase (AST), Creatine | ||
| Kinase (CK), Gamma-Glutamyl | ||
| Transferase (GGT), Lactate | ||
| Dehydrogenase (LD) and Lipase | ||
| (LIP) | ||
| GC4: Direct Bilirubin (DBIL) and | ||
| Total Bilirubin (TBIL) | ||
| Differences | ||
| Issue | SE Device (VK-4 Verification | |
| Kit) | Predicate Device (K091225) | |
| Storage | 2 - 25 °C | 2 – 8 °C |
| Shelf life | 24 months (as a maximum, | |
| depending on the remaining shelf | ||
| life of the oldest component) | 12 months | |
| Open vial stability | N/A, shall be used immediately | 12 months |
| Levels | 4 | 6 |
9
VK-4 Verification Kit
10
VK-R5 Verification Kit
| Similarities | ||
|---|---|---|
| Issue | SE Device (VK-R5 Verification | |
| Kit) | Predicate Device (K091225) | |
| Intended 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. | Validate GC1, GC2, GC3 and GC4 | |
| Calibration Verification/Linearity Test | ||
| Sets are intended for in vitro | ||
| diagnostic use in the quantitative | ||
| determination of linearity, calibration | ||
| verification and verification of | ||
| reportable range in automated, semi | ||
| automated, and manual chemistry | ||
| systems. See attached Package | ||
| Insert labeling for all analytes | ||
| claimed. | ||
| Product code | JJY (Multi-analyte controls, all | |
| kinds (assayed)) | JJY (Multi-analyte controls, all kinds | |
| (assayed)) | ||
| Form | Liquid | Liquid |
| Matrix | Aqueous | GC1: Human serum |
| GC2: Aqueous | ||
| GC3: Human serum | ||
| GC4: Human serum | ||
| Traceability | IUPAC pH scale, NIST SRM, IFCC, | |
| SIGMA | NIST SRM, primary analytical | |
| standards |
11
| Similarities | ||
|---|---|---|
| Issue | SE Device (VK-R5 Verification | |
| Kit) | 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 Urea | |
| Nitrogen (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), Carbon | ||
| Dioxide (CO2), Ethanol (ETOH), and | ||
| Iron (FE) | ||
| GC3: Alkaline Phosphatase (ALP), | ||
| Alanine Aminotransferase (ALT), | ||
| Amylase (AMY), Aspartate | ||
| Aminotransferase (AST), Creatine | ||
| Kinase (CK), Gamma-Glutamyl | ||
| Transferase (GGT), Lactate | ||
| Dehydrogenase (LD) and Lipase | ||
| (LIP) | ||
| GC4: Direct Bilirubin (DBIL) and | ||
| Total Bilirubin (TBIL) | ||
| Storage | 2 - 8 °C | 2 - 8 °C |
| Differences | ||
|---|---|---|
| Issue | SE Device (VK-R5 Verification | |
| Kit) | Predicate Device (K091225) | |
| Shelf life | 24 months (as a maximum, | |
| depending on the remaining shelf | ||
| life of the oldest component) | 12 months | |
| Open vial stability | N/A, shall be used immediately | 12 months |
| Levels | 3 (4 levels for Glu) | 6 |
12
VK-R7 Verification Kit
| Similarities | ||
|---|---|---|
| Issue | SE Device (VK-R7 Verification | |
| Kit) | Predicate Device (K091225) | |
| Intended 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. | Validate GC1, GC2, GC3 and GC4 | |
| Calibration Verification/Linearity Test | ||
| Sets are intended for in vitro | ||
| diagnostic use in the quantitative | ||
| determination of linearity, calibration | ||
| verification and verification of | ||
| reportable range in automated, semi | ||
| automated, and manual chemistry | ||
| systems. See attached Package | ||
| Insert labeling for all analytes | ||
| claimed. | ||
| Product code | JJY (Multi-analyte controls, all | |
| kinds (assayed)) | JJY (Multi-analyte controls, all kinds | |
| (assayed)) | ||
| Form | Liquid | Liquid |
| Matrix | Aqueous | GC1: Human serum |
| GC2: Aqueous | ||
| GC3: Human serum | ||
| GC4: Human serum | ||
| Traceability | IUPAC pH scale, NIST SRM, | |
| SIGMA, IFCC | NIST SRM, primary analytical | |
| standards | ||
| Measurands | pH, pCO2, pO2, cK+, cNa+, | |
| cCa2+, cCl-, cGlu, cLac, ctHb, | ||
| sO2, FO2Hb, FCOHb, FMetHb, | ||
| FHbF and ctBil | GC1: Albumin (ALB), Blood Urea | |
| Nitrogen (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), Carbon | ||
| Dioxide (CO2), Ethanol (ETOH), and | ||
| Iron (FE) | ||
| GC3: Alkaline Phosphatase (ALP), | ||
| Alanine Aminotransferase (ALT), | ||
| Amylase (AMY), Aspartate | ||
| Aminotransferase (AST), Creatine | ||
| Kinase (CK), Gamma-Glutamyl | ||
| Transferase (GGT), Lactate | ||
| Dehydrogenase (LD) and Lipase | ||
| (LIP) | ||
| GC4: Direct Bilirubin (DBIL) and | ||
| Total Bilirubin (TBIL) | ||
| Storage | 2 - 8 °C | 2 - 8 °C |
| Differences | ||
| Issue | SE Device (VK-R7 Verification | |
| Kit) | Predicate Device (K091225) | |
| Shelf life | 24 months (as a maximum, | |
| depending on the remaining shelf | ||
| life 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 |
13
VK-Crea Verification Kit
| Similarities | ||
|---|---|---|
| Issue | SE Device (VK-Crea | |
| Verification Kit) | Predicate Device (K091225) | |
| Intended 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. | Validate GC1, GC2, GC3 and GC4 | |
| Calibration Verification/Linearity Test | ||
| Sets are intended for in vitro | ||
| diagnostic use in the quantitative | ||
| determination of linearity, calibration | ||
| verification and verification of | ||
| reportable range in automated, semi | ||
| automated, and manual chemistry | ||
| systems. See attached Package | ||
| Insert labeling for all analytes | ||
| claimed. | ||
| Product code | JJY (Multi-analyte controls, all | |
| kinds (assayed)) | JJY (Multi-analyte controls, all kinds | |
| (assayed)) | ||
| Form | Liquid | Liquid |
| Matrix | Aqueous | GC1: Human serum |
| GC2: Aqueous | ||
| GC3: Human serum | ||
| GC4: Human serum | ||
| Traceability | NIST SRM | NIST SRM, primary analytical |
| standards |
14
| Similarities | ||
|---|---|---|
| Issue | SE Device (VK-Crea | |
| Verification Kit) | Predicate Device (K091225) | |
| Measurands | cCrea | GC1: Albumin (ALB), Blood Urea |
| Nitrogen (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), Carbon | ||
| Dioxide (CO2), Ethanol (ETOH), and | ||
| Iron (FE) | ||
| GC3: Alkaline Phosphatase (ALP), | ||
| Alanine Aminotransferase (ALT), | ||
| Amylase (AMY), Aspartate | ||
| Aminotransferase (AST), Creatine | ||
| Kinase (CK), Gamma-Glutamyl | ||
| Transferase (GGT), Lactate | ||
| Dehydrogenase (LD) and Lipase | ||
| (LIP) | ||
| GC4: Direct Bilirubin (DBIL) and | ||
| Total Bilirubin (TBIL) | ||
| Storage | 2 - 8 °C | 2 - 8 °C |
| Shelf life | 12 months (as a maximum, | |
| depending on the remaining shelf | ||
| life of the oldest component) | 12 months |
| Differences | ||
|---|---|---|
| Issue | SE Device (VK-Crea | |
| Verification Kit) | Predicate Device (K091225) | |
| Open vial stability | N/A, shall be used immediately | 12 months |
| Levels | 4 | 6 |
15
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