(236 days)
Not Found
No
The summary describes a quality control material for diagnostic assays and does not mention any AI or ML components or functionalities.
No.
The device is an in-vitro diagnostic quality control material used to monitor the accuracy or reproducibility of diagnostic assays, not for treating a disease or condition.
No
The device is an assayed quality control material for in vitro diagnostic use, meaning it monitors the performance of diagnostic assays rather than directly diagnosing conditions itself.
No
The device description clearly states the device is "human liquid sera" and is supplied in "vials," indicating it is a physical material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the material is "intended for in vitro diagnostic use in the quality control of diagnostic assays."
- Device Description: The description details a material used to monitor the accuracy or reproducibility of analytes, which is a key function of an in vitro diagnostic control.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K130162) indicates that this device is being compared to a previously cleared medical device, which is a common process for IVDs.
The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases or other conditions. This device fits that description as it is used to control the quality of diagnostic assays performed on biological samples.
N/A
Intended Use / Indications for Use
The Liquid Assayed Chemistry Control Premium Plus Levels 1, 2 and 3 are assayed quality control materials intended for in vitro diagnostic use in the quality control of diagnostic assays. This material can be used to monitor the accuracy or reproducibility of analytes listed in the package insert. This device is for prescription use only.
Product codes
JJY
Device Description
The Liquid Assayed Chemistry Control Premium Plus is human liquid sera to which purified biochemical material, chemicals, drugs, preservatives and stabilizers have been added. The material is supplied at levels 1, 2 and 3. Each 5 ml vial of liquid serum is stored at -20°C to -70°C.
Each level is supplied in a 12 by 5ml vials.
Human source material from which this product has been derived and has been tested at the donor level for the Human Immunodeficiency Virus (HIV1 & HIV2) antibody, Hepatitis B surface antigen (HbsAg) and the Hepatitis C virus (HCV) antibody and were found to be non-reactive based on FDA approved methods.
However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples should be handled as though capable of transmitting infectious diseases and disposed of accordingly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Thawed Open vial stability
Thawed Open vial stability of the Liquid Assayed Chemistry Control Premium Plus levels 1, 2 & 3 was assessed by removing the product from the routine storage temperature of -18 to -24°C, thawed at +15 to 25°C and stored at +2 to 8°C for 3 and 8 days.
All acceptance criteria were met for all the analytes
The data demonstrates that the Liquid Assayed Chemistry Control Premium Plus Control levels 1, 2 & 3 are stable for 7 days when thawed and stored + 2 to 8°C. Troponin T is stable for 3 days when thawed and stored at +2℃ to +8℃.
Shelf-life Study
Real Time Testing
The Liquid Assayed Chemistry Control Premium Plus levels 1, 2 & 3 were stored at ultra frozen conditions -75 to -90°C. Following storage at the ultra frozen temperature, the controls were then tested alongside control material stored unopened at the routine storage temperature of -18°C to -24°C at various time points and the percentage deviation is calculated.
All acceptance criteria were met for all the analytes
Current Real Time studies support an 18 month shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff entwined with a serpent, and three human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 8, 2014
RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG, QA/REGULATORY AFFAIRS MANAGER 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM BT29 4QY UNITED KINGDOM
Re: K140971
Trade/Device Name: Liquid Assayed Chemistry Control Premium Plus Level 1,2 and 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class 1, Reserved Product Code: JJY Dated: October 31, 2014 Received: October 31, 2014
Dear Dr. Pauline Armstrong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140971
Device Name
Liguid Assayed Chemistry Control Premium Plus Level 1, Level 2 and Level 3
Indications for Use (Describe)
The Liquid Assayed Chemistry Control Premium Plus Levels 1, 2 and 3 are assayed quality control materials intended for in vitro diagnostic use in the quality control of diagnostic assays. This material can be used to monitor the accuracy or reproducibility of analytes listed in the package insert. This device is for prescription use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
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510(K) SUMMARY, LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVELS 1, 2 AND 3
1. SAFETY AND EFFECTIVENESS AS REQUIRED BY 21 CFR 807.92 STATEMENT
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirement 21 CFR 807.92.
2. SUBMITTER NAME AND ADDRESS
Name: Dr Pauline Armstrong
Address: Randox Laboratories Limited 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom.
Telephone: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 E-mail: Pauline.Armstrong@randox.com
Date of Summary Preparation: December 5, 2014
3. 510k NUMBER, DEVICE PROPRIETARY NAME, COMMON NAME, PURPOSE FOR SUBMISSION, REGULATORY CLASSIFCATION, PANEL, PRODUCT CODE AND 21 CFR NUMBER
510k No: K140971
Device Proprietary Name: Liquid Assayed Chemistry Control Premium Plus Levels 1, 2 & 3
Common Name: Liquid Assayed Chemistry Control Premium Plus Levels 1, 2 & 3
Purpose for Submission: New Device
Requlatory Classification: Multi-analyte Controls, All kinds (Assayed and Unassayed)
Panel: Clinical Chemistry
Product Code: JJY 21 CFR Number: 21 CFR 862.1660
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4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS
Predicate Device Proprietary Name: Bio-rad Laboratories, Liquid Assayed Multiqual Premium
510 (k) Number: K130162
5. INTENDED USE
The Liquid Assayed Chemistry Control Premium Plus Levels 1, 2 and 3 are assayed quality control materials intended for in vitro diagnostic use in the quality control of diagnostic assays. This material can be used to monitor the accuracy or reproducibility of analytes listed in the package insert. This device is for prescription use only.
6. DEVICE DESCRIPTION
The Liquid Assayed Chemistry Control Premium Plus is human liquid sera to which purified biochemical material, chemicals, drugs, preservatives and stabilizers have been added. The material is supplied at levels 1, 2 and 3. Each 5 ml vial of liquid serum is stored at -20°C to -70°C.
Each level is supplied in a 12 by 5ml vials.
Human source material from which this product has been derived and has been tested at the donor level for the Human Immunodeficiency Virus (HIV1 & HIV2) antibody, Hepatitis B surface antigen (HbsAg) and the Hepatitis C virus (HCV) antibody and were found to be non-reactive based on FDA approved methods.
However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples should be handled as though capable of transmitting infectious diseases and disposed of accordingly.
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7. PREDICATE DEVICE COMPARISON TABLE
COMPARISON OF LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVELS 1, 2 AND 3 WITH THE PREDICATE DEVICE
| CHARACTERISTICS | LIQUID ASSAYED CHEMISTRY
CONTROLPREMIUM PLUS LEVELS 1, 2
AND 3
(New Device) | BIO-RAD LABORATORIES
LIQUID ASSAYED MULTIQUAL
PREMIUM K130162
(Predicate Device) | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Differences | | | |
| ANALYTES | Total: 98 Analytes
Alpha-1-Acid Glycoprotein, Alpha-1-
Antitrypsin, Total Acid Phosphatase, Albumin,
Alkaline Phosphatase, alpha-HBDH, ALT,
Amikacin, Amylase Pancreatic, Amylase
Total, APO A-1, APO B, AST, Beta-2-
microglobulin, Bicarbonate, Bile Acids,
Bilirubin Direct, Bilirubin Total, C3, C4,
Caffeine, Calcium, Carbamazepine,
Ceruloplasmin, Chloride, Cholesterol,
Cholinesterase, CK Total, Copper, Cortisol,
Creatinine, CRP, DHEA-S, D-3-
Hydroxybutyate, Digoxin, Electrophoresis
(albumin, alpha-1-globulin, alpha-2-globulin,
beta-globulin, gamma-globulin), Ethanol,
Ferritin, Folate, Free T3, Free T4, FSH,
Gamma-GT, Gentamicin, GLDH, Glucose,
Haptoglobin, HDL, Immunoglobulin A,
Immunoglobulin E, Immunoglobulin G,
Immunoglobulin M, Iron, Lactate, LAP, LDH,
LDL, LH, Lipase, Lp(a), Lithium, Magnesium,
Myoglobin, Osmolality, Paracetamol,
Phenobarbital, Phenytoin, Phosphate
Inorganic, Potassium, Prealbumin,
Progesterone, Prolactin, Protein Total, PSA
Total, Salicylate, Sodium, Testosterone,
Theophylline, Total beta hCG Total T3, Total
T4, TSH, TIBC, Transferrin, Triglycerides,
Troponin T, T uptake, Urea, Uric Acid,
Valproic acid, Vancomycin, Vitamin B12, Zinc. | Total: 78 Analytes
Alpha-1-Acid Glycoprotein, Alpha-1-
Antitrypsin, Albumin, Alkaline
Phosphatase, alpha-HBDH, ALT,
Amikacin, Amylase Pancreatic, Amylase
Total, ASO, AST, Beta-2-microglobulin,
Bicarbonate, Bilirubin Direct, Bilirubin
Total, C3, C4, Caffeine, Calcium,
Carbamazepine, Ceruloplasmin, Chloride,
Cholesterol, Cholinesterase, CK Total,
Copper, Cortisol, Creatinine, CRP,
Cystatin C, Ethanol, Ferritin, , Free T3,
Free T4, Gamma-GT,
Gentamicin, Glucose, Haptoglobin, HDL,
Immunoglobulin A, Immunoglobulin G,
Immunoglobulin M, Iron, Lactate, LDH,
LDL, Lipase, Lithium, Lidocaine,
Magnesium, Methotrexate, NAPA,
Osmolality, Paracetamol, Phenobarbital,
Phenytoin, Phosphate Inorganic,
Potassium, Prealbumin, Procainamide,
Protein Total, Quinidine, Salicylate,
Sodium, Theophylline, Tobramycin, Total
T3, Total T4, TSH, TIBC, Transferrin,
Triglycerides, T uptake, Urea, Uric Acid,
Valproic acid, Vancomycin, Vitamin B12. | |
| OPEN VIAL CLAIM | Store refrigerated at +2 to +8°C. Thawed
serum is stable for 7 days with the following
exceptions: Troponin T is stable for 3 days at
+2 to +8°C. | Once the control material is thawed and
opened, all analytes will be stable for 14
days when stored tightly capped at 2 to
8°C, with the following exceptions: Direct
Bilirubin will be stable for 11 days,
Triglycerides, HDL, Cholinesterase and
Phosphorous will be stable for 7 days. | |
| SIZE | 12 x 5ml | 6 x 5ml | |
| Similarities | | | |
| INTENDED USE | The Liquid Assayed Chemistry Control
Premium Plus Levels 1, 2 and 3 are assayed
quality control materials intended for in vitro
diagnostic use in the quality control of
diagnostic assays. This material can be used
to monitor the accuracy or reproducibility of
analytes listed in the package insert. This
device is for prescription use only. | Liquid assayed Multiqual Premium 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. | |
| FORMAT | Liquid | Liquid | |
| MATRIX | Human Serum | Human Serum | |
| STORAGE
(Unopened) | Until expiration date at -20 to -70°C | Until expiration date at -20 to -70°C | |
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8. SUMMARY OF STABILITY STUDIES
Thawed Open vial stability
Thawed Open vial stability of the Liquid Assayed Chemistry Control Premium Plus levels 1, 2 & 3 was assessed by removing the product from the routine storage temperature of -18 to -24°C, thawed at +15 to 25°C and stored at +2 to 8°C for 3 and 8 days.
All acceptance criteria were met for all the analytes
The data demonstrates that the Liquid Assayed Chemistry Control Premium Plus Control levels 1, 2 & 3 are stable for 7 days when thawed and stored + 2 to 8°C. Troponin T is stable for 3 days when thawed and stored at +2℃ to +8℃.
Shelf-life Study
Real Time Testing
The Liquid Assayed Chemistry Control Premium Plus levels 1, 2 & 3 were stored at ultra frozen conditions -75 to -90°C. Following storage at the ultra frozen temperature, the controls were then tested alongside control material stored unopened at the routine storage temperature of -18°C to -24°C at various time points and the percentage deviation is calculated.
All acceptance criteria were met for all the analytes
Current Real Time studies support an 18 month shelf life.
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9. SUMMARY OF VALUE ASSIGNMENT
Each batch of Liquid Assayed Chemistry Control Premium Plus is submitted to a number of external laboratories and values are assigned from results obtained by these laboratories and/or by in-house testing. Statistical analysis including the mean, SD and % CV were calculated. With each batch, an assigned value is calculated from the target mean specific value and an analyte specific fixed percentage range is applied. Average values should normally fall within the listed range. However, variations may be caused by instrument, reagent, and laboratory technique. Therefore the range provided should only be considered as a reference and it is recommended that each laboratory establish its own ranges. All the assigned values for all the specific analyzers tested are printed in the package insert.
10. TRACEABILITY
Randox Liquid Assayed Chemistry Controls Premium Plus Levels 1, 2, and 3 were obtained from commercially available sources. Control solutions are derived from gravimetrically prepared stock solutions and analyzed in-house
11. CONCLUSION
Testing results indicate that the proposed device is substantially equivalent to the predicate device.