(28 days)
Not Found
No
The summary describes a quality control material for laboratory testing, not a device that processes data or images using AI/ML. The value assignment process is a standard statistical calculation.
No
This device is an in vitro diagnostic quality control material used to verify the performance of laboratory testing procedures, not to treat or diagnose a disease in a patient.
No
This device is a quality control material intended to verify the performance of laboratory testing procedures, not to diagnose a condition in a patient.
No
The device description clearly states it is a physical control material prepared from haemolysed human blood, supplied in lyophilised form in vials, requiring reconstitution. This is a physical in vitro diagnostic device, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: Explicitly states "intended for in vitro diagnostic use as quality control material".
- Device Description: Describes the material as being prepared from haemolysed human blood and intended for use on "clinical chemistry systems".
- Intended User / Care Setting: Mentions "laboratory testing procedures on clinical chemistry systems".
These points clearly indicate that the device is intended to be used outside of the body to examine specimens (in this case, the control material itself) to provide information for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HbA1c Controls Level 1 and 2 are intended for in vitro diagnostic use as quality control material for use to verify the performance of laboratory testing procedures of HbA1c on clinical chemistry systems. This device is intended for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
HbA1c Controls are manufactured at two levels, Level 1 and Level 2. Each control is prepared from haemolysed human blood with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilised form in 2x0.5ml vials and require reconstitution with 0.5ml of distilled water.
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
laboratory testing procedures
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)
SUMMARY OF STABILITY STUDIES
Opened: Store refrigerated (+2℃ to +8℃). Reconstituted HbA1c is stable for 1 month at +2℃ to +8℃ if kept capped in the original container and free from contamination. 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
Value assignment is used to calculate a target value for the HbA1c Controls level 1 and 2 on various clinical chemistry analysers. A target value is calculated for each new lot of controls by taking the mean of at least two replicates on each clinical chemistry analyser. The NGSP aligned values are taken from external laboratories, a consensus mean calculated which is then converted to IFCC values using the following master formula:
IFCC = (NGSP - 2.15) x 10.929
The acceptance criteria states the precision measured by the CV should be less than or equal to 10% for each clinical chemistry analyser. An assigned tarqet value is applied and a +/-20% range applied.
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.
Not Found
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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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:
Device Proprietary Name: HbA1c Control Levels 1 and 2
Common Name: HbA1c Controls Levels 1 and 2
Purpose for Submission: New Device
Single Specified Analyte Controls (Assayed and Regulatory Classification: Unassaved) Class I reserved
Panel: Clinical Chemistry
Product Code: JJX
21 CFR Number: 21 CFR 862.1660
JUL 26 2013
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4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS
Predicate Device Proprietary Name:
Roche PreciControl HbA1c norm and PreciControl HbA1c path
510 (k) Number: K103099
5. INTENDED USE
The HbA1c Controls Level 1 and 2 are intended for in vitro diagnostic use as quality control material for use to verify the performance of laboratory testing procedures of HbA1c on clinical chemistry systems. This device is intended for prescription use only.
6. DEVICE DESCRIPTION
HbA1c Controls are manufactured at two levels, Level 1 and Level 2. Each control is prepared from haemolysed human blood with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilised form in 2x0.5ml vials and require reconstitution with 0.5ml of distilled water.
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7. PREDICATE DEVICE COMPARISON TABLE
COMPARISON OF RANDOX HbA1c CONTROLS LEVEL 1 AND 2 WITH THE PREDICATE DEVICE
| CHARACTERISTICS | RANDOX
HbA1c CONTROLS LEVEL 1
AND LEVEL 2 | ROCHE
PRECICONTROL HbA1c norm
PRECICONTROL HbA1c path
K103099 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| INTENDED USE | For use in quality control by monitoring
accuracy and precision for the
quantitative methods as specified in the
value sheets | Same |
| SIZE | 0.5ml | 1ml |
| FORMAT | Lyophilised | Liquid |
| REAGENT
COMPOSITION | Matrix
The controls are based on haemolysed
human blood
Components | Matrix
Same
Components |
| | HbA1c is isolated from human blood | HbA1c is isolated from a normal
population then glycated in vitro |
| STABILITY | Unopened | Unopened |
| | 2-8°C until expiration | Same |
| | Stability after opening | Stability after opening |
| | 2-8°C for 1 month | 2-8°C for 28 days
(-15)-(-25)°C for 12 weeks (freeze only
once) |
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8. SUMMARY OF STABILITY STUDIES
Opened: Store refrigerated (+2℃ to +8℃). Reconstituted HbA1c is stable for 1 month at +2℃ to +8℃ if kept capped in the original container and free from contamination. 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
Value assignment is used to calculate a target value for the HbA1c Controls level 1 and 2 on various clinical chemistry analysers. A target value is calculated for each new lot of controls by taking the mean of at least two replicates on each clinical chemistry analyser. The NGSP aligned values are taken from external laboratories, a consensus mean calculated which is then converted to IFCC values using the following master formula:
IFCC = (NGSP - 2.15) x 10.929
The acceptance criteria states the precision measured by the CV should be less than or equal to 10% for each clinical chemistry analyser. An assigned tarqet value is applied and a +/-20% range applied.
10. TRACEABILITY
NGSP aligned values are obtained from external laboratories using NGSP certified methods. IFCC values are calculated from the NGSP values using the master equation:
IFCC = (NGSP - 2.15) x 10.929
| ANALYTE | Reference
Material | Assignment
Method | ORIGIN |
|---------|--------------------------------------------|----------------------|---------------------------|
| HbA1c | Traceable to
IFCC by master
equation | Consensus Mean | Human
Haemolysed Blood |
11. CONCLUSION
Testing results indicate that the proposed device is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing movement and progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol, indicating the department's name and national affiliation. The logo is in black and white, giving it a formal and official appearance.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26, 2013
Randox Laboratories C/O Pauline Armstrong 55 Diamond Road Crumlin, Co Antim, BT294QY, UK
Re: K131999 Trade/Device Name: HbAlc Controls Level 1 HbAlc Controls Level 2 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: II Product Code: JJX Dated: June 26, 2013 Received: June 28, 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 includines 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 Amendmonts or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drig 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, fisting 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 misleding.
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 CEP Port 807), Intelige (21 City in the Post of other it of the registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050.
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Page 2-Ms. Armstrong
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney H. Lias, Ph.D.
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K131999
Device Name: HbA1c Control Level 1 and HbA1c Control Level 2
Indication for Use:
The HbAlc Controls Level 1 and 2 are intended for in vitro diagnostic use as quality control material for use to verify the performance of laboratory testing procedures of HbAlc on clinical chemistry systems.
This in vitro diagnostic device is intended for prescription use only.
Prescription Use _ V (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 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)
Katherine Serrano -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K131999