(28 days)
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.
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.
The provided document describes the Randox HbA1c Controls Level 1 and 2, which are quality control materials for verifying the performance of laboratory testing procedures of HbA1c on clinical chemistry systems. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets an inherent set of acceptance criteria for its own performance.
Therefore, it is important to note that the acceptance criteria and study described below are derived from the information available in the 510(k) summary, primarily focusing on the value assignment process for the controls and the comparison to the predicate device, rather than a standalone clinical study on the device's diagnostic accuracy.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Reported Device Performance (for Value Assignment) |
|---|---|
| Precision (Coefficient of Variation, CV) | CV should be ≤ 10% for each clinical chemistry analyzer. (Implied met for value assignment) |
| Assigned Target Value Range | +/- 20% range applied to the assigned target value. (Implied met for value assignment) |
| Stability - Opened (2-8°C) | 1 month (if kept capped, original container, free from contamination) |
| Stability - Unopened (2-8°C) | Until expiration date printed on vials |
| Equivalence to Predicate Device | Assessed to be "Substantially Equivalent" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of diagnostic accuracy or a clinical study for the quality control material itself. The "testing results" mentioned in the conclusion refer to the overall evaluation for substantial equivalence to the predicate device, which includes the value assignment process and stability data.
- Sample Size for Value Assignment: For value assignment, "at least two replicates on each clinical chemistry analyser" are used to calculate a target value. External laboratories contribute NGSP aligned values. The specific number of these external laboratories or the total number of replicates across all analyzers is not stated.
- Data Provenance: The NGSP aligned values are taken from "external laboratories." The country of origin is not specified, nor is whether the data is retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable in the traditional sense for a quality control device. The "ground truth" for the controls is the assigned target value.
- Number of Experts: Not applicable. The value assignment method relies on consensus mean from "external laboratories" using NGSP certified methods. These laboratories are assumed to have qualified personnel, but individual experts are not quantified or specified.
- Qualifications of Experts: Not specified. It's implied that the external laboratories use "NGSP certified methods," suggesting that the personnel performing these measurements are qualified to do so, but their specific qualifications (e.g., years of experience, specific certifications) are not detailed.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" for diagnostic performance in the context of human adjudication for this quality control material. The value assignment process uses a consensus mean.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is designed to assess the performance of a diagnostic device or algorithm in conjunction with human readers. This document describes a quality control material, not a diagnostic device intended to be used by human readers to interpret clinical cases.
6. If a Standalone Study Was Done
Yes, in the sense that the device's performance characteristics (stability and value assignment) were evaluated independently. However, this is not a "standalone" study in the typical AI/diagnostic algorithm context focusing on diagnostic accuracy.
- Standalone Performance: The stability studies (opened and unopened) and the value assignment process describe the performance of the Randox HbA1c Controls themselves.
- Value Assignment: Target values are calculated as the mean of at least two replicates on each clinical chemistry analyzer, and an acceptance criterion for CV (≤ 10%) is applied. A +/-20% range is applied to the assigned target value.
- Stability: Open stability is 1 month at 2-8°C. Unopened stability is until the expiration date at 2-8°C.
7. The Type of Ground Truth Used
The "ground truth" for the HbA1c Controls is their assigned target value. This is established through:
- Consensus Mean: Aggregation of values obtained from "external laboratories" using "NGSP certified methods."
- Traceability: Traceable to IFCC by a master equation and NGSP aligned values.
- Reference Material: Traceable to IFCC by master equation.
8. The Sample Size for the Training Set
Not applicable. This device is a quality control material and does not involve AI/machine learning algorithms that require a "training set" for model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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 | RANDOXHbA1c CONTROLS LEVEL 1AND LEVEL 2 | ROCHEPRECICONTROL HbA1c normPRECICONTROL HbA1c pathK103099 |
|---|---|---|
| INTENDED USE | For use in quality control by monitoringaccuracy and precision for thequantitative methods as specified in thevalue sheets | Same |
| SIZE | 0.5ml | 1ml |
| FORMAT | Lyophilised | Liquid |
| REAGENTCOMPOSITION | MatrixThe controls are based on haemolysedhuman bloodComponents | MatrixSameComponents |
| HbA1c is isolated from human blood | HbA1c is isolated from a normalpopulation 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 onlyonce) |
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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 | ReferenceMaterial | AssignmentMethod | ORIGIN |
|---|---|---|---|
| HbA1c | Traceable toIFCC by masterequation | Consensus Mean | HumanHaemolysed 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
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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
§ 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.