(128 days)
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No
The document describes a quality control material for laboratory testing and does not mention any AI or ML components in its description or intended use.
No
The device is described as an "in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures" and is not intended to treat or prevent disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Randox Immunoassay Speciality Control (I) Levels 1, 2 and 3 are intended for in vitro diagnostic use..."
No
The device description clearly states it is a lyophilized material prepared from human serum with added constituents, supplied in vials, requiring reconstitution. This describes a physical, chemical product, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The Randox Immunoassay Speciality Control (I) Levels 1, 2 and 3 are intended for in vitro diagnostic use as assayed quality control material..." This is the most direct indicator.
- Function: The device is used to "monitor the precision of laboratory testing procedures for the analytes listed in the package insert." This function of quality control in a laboratory setting is a core aspect of IVD devices.
- Device Description: The description details its composition (human serum with added constituents, chemicals, stabilizers, and preservatives) and form (lyophilised vials requiring reconstitution), which are typical characteristics of laboratory reagents and controls used in IVD testing.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K043108) indicates that this device is being compared to a previously cleared IVD device by a regulatory body (like the FDA in the US). This further confirms its classification as an IVD.
Therefore, the information provided clearly identifies the Randox Immunoassay Speciality Control (I) as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Randox Immunoassay Speciality Control (I) Levels 1, 2 and 3 are intended for in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. This device is for prescription use only.
The Randox Immunoassay Speciality Control (I) Levels 1, 2 and 3 are intended for in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for 1-25 Dihydroxy Vitamin D (1-25 (OH)2 Vitamin D), 25 Hydroxy Vitamin D (25 OH Vitamin D), Anti-Thyroglobulin (Anti TG), Anti-Thyroid Peroxidase (Anti TPO), C-Peptide, Insulin Like Growth Factor (IGF 1), Parathyroid Hormone (PTH), Procalcitonin and Insulin. This device is for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
Randox Immunoassay Speciality Control (I) is manufactured at three levels, Level 1. Level 2 and Level 3.
Each control is prepared from human serum with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilised form in 5x2ml vials and require reconstitution with 2ml of distilled water.
The analyte concentrations in each of the three levels have been chosen to span a range that includes the chemically significant or medical decision level(s). The analyte concentrations have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
SUMMARY OF STABILITY STUDIES
Opened: Store refrigerated (+2°C to +8°C). Reconstituted serum is stable for 5 days at +2°C to +8°C if kept capped in the original container and free from contamination or 4 weeks frozen once at -20℃. Anti-TG is stable for 3days at +2°C to +8°C. C-Peptide, IGF-I and Procalcitonin are stable for 1day at +2°C to +8°C. Osteocalcin is stable for 4 hours at +2°C to +4°C. Parathyroid hormone (PTH) should be tested within 4hours of reconstitution when stored at +2℃ to +8°C, or within 2 weeks when stored below -20°C. Only the required amount of product should be removed. After use, any residual product should not be returned to the original vial.
Unopened: Store refrigerated (+2℃ to +8℃), Stable to the expiration date printed on individual vials.
SUMMARY OF VALUE ASSIGNMENT
Each batch of Immunoassay Speciality | Control is submitted to a number of reference laboratories and values are assigned from a consensus of results obtained by these laboratories using a unique statistical analysis. With each batch a control range is provided for individual parameters and each parameter method. Average values should normally fall within the listed range for analytes specified in the product insert. However, variations may be caused by instrument, reagent, and laboratory technique. Therefore ranged provided here in should only be considered as a reference and it is recommended that each laboratory establish its not ranges.
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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JUN 1 9 2013
- Participant
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510(k) Summary
Date of Preparation: 22nd January 2013
.
.
1
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: Randox Laboratories Limited
Address: 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom.
Telephone: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 E-mail: marketing@randox.com
3. 510k NUMBER, DEVICE PROPRIETARY NAME, COMMON NAME, PURPOSE FOR SUBMISSION, REGULATORY CLASSIFCATION, PANEL, PRODUCT CODE AND 21 CFR NUMBER
510k No: Not known
Device Proprietary Name: Randox Immunoassay Speciality Control (I) Levels 1, 2 and 3
Common Name: Immunoassay Speciality Control (I) Levels 1, 2 and 3
Purpose for Submission: New Device
Regulatory 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 Liquichek 110 Speciality Immunoassay Control Levels LTA Levels 1, 2 and 3.
510 (k) Number: K043108
5. INTENDED USE
The Randox Immunoassay Speciality Control (I) Levels 1, 2 and 3 are intended for in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. This device is for prescription use only.
6. DEVICE DESCRIPTION
Randox Immunoassay Speciality Control (I) is manufactured at three levels, Level 1. Level 2 and Level 3.
Each control is prepared from human serum with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilised form in 5x2ml vials and require reconstitution with 2ml of distilled water.
The analyte concentrations in each of the three levels have been chosen to span a range that includes the chemically significant or medical decision level(s). The analyte concentrations have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.
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7. PREDICATE DEVICE COMPARISON TABLE
| CHARACTERISTICS | RANDOX SPECIALITY
IMMUNOASSAY CONTROL (I)
LEVELS 1, 2 AND 3 | BIO-RAD
LIQUICHEK TM
SPECIALTY IMMUNOASSAY
CONTROL LTA LEVELS 1, 2 & 3
K043108 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE | The Randox Immunoassay Speciality
Control (I), levels 1, 2 & 3 are intended for
in vitro diagnostic use as assayed quality
control material to monitor the precision of
laboratory testing procedures for the
analytes listed in the package insert. | For use as a quality control serum to
monitor the precision of laboratory testing
procedures listed in the package insert |
| SIZE | 2ml | 5ml |
| FORMAT | Lyophilised | Liquid |
| MATRIX | Human Serum | Human Serum |
| STORAGE
(Unopened) | 2 to 8 °C
Until expiration date | -20 to -70°C
Until expiration date |
| OPEN VIAL CLAIM | Store refrigerated +2 to 8°C
Reconstituted serum is stable for 5days at
+2 to 8°C if kept capped in original
container or 4weeks frozen once at -20°C.
Anti-TG is stable for 3days at +2 to 8°C.
C-Peptide, IGF-I and Procalcitonin are
stable for 1day at +2 to 8°C. Osteocalcin
is stable for 4hours at +2 to 8°C and
Parathyroid hormone should be tested
within 4hours of reconstitution when
stored at +2 to 8°C or within 2weeks when
stored below -20°C. | Once the product is thawed and opened,
all analytes will be stable for 30days when
stored tightly capped at 2-8°C with the
exception of PTH which will be stable for
23days.
PTH, Anti-TG and Anti TPO will be stable
for 30 days when stored in tightly capped
aliquot vials at -20°C to -70°C. |
| SHIPPING
TEMPERATURE | +2 to 8°C | -20 to -70°C |
| ANALYTES | 1-25 OH Vitamin D, 25 OH Vitamin D,
Anti TG, Anti TPO, C-Peptide, Insulin Like
Growth Factor (IGF 1), Osteocalcin,
Parathyroid Hormone (PTH)
Insulin | Anti-Thyroglobulin (Anti-TG)
Anti-Thyroperoxidase (Anti-TPO)
C-Peptide
Insulin Like Growth Factor I (IGF-I)
Intact Parathyroid Hormone
(Intact-PTH)
25-OH Vitamin D
Osteocalcin |
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
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·
:
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8. SUMMARY OF STABILITY STUDIES
Opened: Store refrigerated (+2°C to +8°C). Reconstituted serum is stable for 5 days at +2°C to +8°C if kept capped in the original container and free from contamination or 4 weeks frozen once at -20℃. Anti-TG is stable for 3days at +2°C to +8°C. C-Peptide, IGF-I and Procalcitonin are stable for 1day at +2°C to +8°C. Osteocalcin is stable for 4 hours at +2°C to +4°C. Parathyroid hormone (PTH) should be tested within 4hours of reconstitution when stored at +2℃ to +8°C, or within 2 weeks when stored below -20°C. Only the required amount of product should be removed. After use, any residual product should not be returned to the original vial.
Unopened: Store refrigerated (+2℃ to +8℃), Stable to the expiration date printed on individual vials.
9. SUMMARY OF VALUE ASSIGNMENT
Each batch of Immunoassay Speciality | Control is submitted to a number of reference laboratories and values are assigned from a consensus of results obtained by these laboratories using a unique statistical analysis. With each batch a control range is provided for individual parameters and each parameter method. Average values should normally fall within the listed range for analytes specified in the product insert. However, variations may be caused by instrument, reagent, and laboratory technique. Therefore ranged provided here in should only be considered as a reference and it is recommended that each laboratory establish its not ranges.
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10. TRACEABILITY
| ANALYTE | SUPPLIER | PRODUCT
NUMBER | ORIGIN | SOURCE |
|------------------------------|--------------------|---------------------------------|-------------------------------------------|--------------------------------------------|
| 1-25 OH Vitamin D | Sigma | D-1530 | Synthetic
Analytical Grade
chemical | Commercial source, added
volumetrically |
| 25-OH Vitamin D | Sigma | H-4014 | Synthetic
Analytical Grade
chemical | Commercial source, added
volumetrically |
| Anti TG | Access Biologicals | Received
under lot
number | Human Plasma | Commercial source, added
volumetrically |
| Anti TPO | Access Biologicals | Received
under lot
number | Human Plasma | Commercial source, added
volumetrically |
| C-Peptide | Sigma | C-4999 | Human Peptide | Commercial source, added
volumetrically |
| IGF 1 | Scipac | P264-0 | Expressed in
E.coli | Commercial source, added
volumetrically |
| Insulin | Sigma | 1-0259/1-2643 | Human
recombinant | Commercial source, added
volumetrically |
| Osteocalcin | Anaspec/Sigma | 22831/0-5761 | Human Bone | Commercial source, added
volumetrically |
| Procalcitonin | Randox | RCP9522 | Extracted and
purified from
E.coli | Commercial source, added
volumetrically |
| Parathyroid Hormone
(PTH) | Sigma | P-7036 | Human Thyroid | Commercial source, added
volumetrically |
11. CONCLUSION
Testing results indicate that the proposed device is substantially equivalent to the predicate devices. :
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping, curved lines, which is the department's official emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2013 ·
RANDOX LABORATORIES LTD. C/O Ms. PAULINE ARMSTRONG QA/RA MANAGER 55 DIAMOND ROAD CRUMLIN CO ANTRIM BT29 4QY UNITED KINGDOM
Re: K130337
Trade/Device Name: Immunoassay Speciality Control (I) levels 1, 2 and 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I Product Code: JJY Dated: April 12, 2013 Received: May 20, 2013
Dear Ms. 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-ofdevices, 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
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Page 2-Ms. Pauline Armstrong
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Maria M. @han -S
Maria M. Chan, Ph. D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological -- Health
Center for Devices and Radiological Health
Enclosure
8
Indications for Use
·510(k) Number (if known): K130337
Immunoassay Speciality Control (I) Levels 1, 2 and 3 Device Name:
Indications For Use:
The Randox Immunoassay Speciality Control (I) Levels 1, 2 and 3 are intended for in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for 1-25 Dihydroxy Vitamin D (1-25 (OH)2 Vitamin D), 25 Hydroxy Vitamin D (25 OH Vitamin D), Anti-Thyroglobulin (Anti TG), Anti-Thyroid Peroxidase (Anti TPO), C-Peptide, Insulin Like Growth Factor (IGF 1), Parathyroid Hormone (PTH), Procalcitonin and Insulin.
This device is for prescription use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Maria M.Chan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k): K130337