(104 days)
The Randox CSF Controls Levels 2 and Level 3 are intended for in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for Clinical Chemistry systems. This device is intended for prescription use only.
The Randox CSF controls consist of a buffered aqueous solution with biological materials; they are supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the following analytes at both levels: Chloride, Glucose, IgG, Lactic Acid, Sodium, Total Protein (Pyrogallol Red), and % Total Protein quoted for Electrophoresis regions at both levels: Albumin, Alpha-1-Globulin, Alpha-2-Globulin, Beta Globulin and Gamma Globulin.
The Randox CSF Controls Levels 2 and 3 are in vitro diagnostic devices. The acceptance criteria and the study proving the device meets these criteria are detailed below, primarily focusing on stability and value assignment studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Study/Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Open Vial Stability | Percentage deviation of 14-day reconstituted vial to fresh vial should be ± 3% (for Chloride, Glucose, Lactate, Sodium, and Total Protein). | Control Level 2 (Lot 059CF): Stable for 14 days reconstituted and stored at +2-8°C. Control Level 3 (Lot 060CF): Stable for 14 days reconstituted and stored at +2-8°C. (Specific deviation percentages per analyte are not provided in the summary but it's stated the data "demonstrates" stability within the criteria.) |
| Shelf Life (Real-time Stability) | Control recovery for routinely stored samples compared to ultra-frozen samples should be within ± 15% deviation (for Total Protein, and implicitly for other analytes calculated as a percentage of Total Protein). | Control Level 2 (Lot 038CF): Tested and passed for 37 months. Control Level 3 (Lot 035CF): Tested and passed for 37 months. This exceeds the claimed shelf life of 3 years by 1 month. |
| Value Assignment (Level 2 - Electrophoresis analytes) | For Albumin: Percentage Range Applied (%) 10% (53.9 - 65.9). For Alpha-1-globulin, Alpha-2-globulin, Beta-globulin, Gamma-globulin: Percentage Range Applied (%) 25%. | Target values and acceptable ranges are provided for each analyte. The study implies that target values are successfully assigned and fall within these specified ranges. Albumin: Target 59.9, Range 53.9 - 65.9 Alpha-1-globulin: Target 2.0, Range 1.5 – 2.5 Alpha-2-globulin: Target 4.6, Range 3.5 - 5.8 Beta-globulin: Target 5.3, Range 4.0 - 6.6 Gamma-globulin: Target 28.3, Range 21.2 - 35.4 |
| Value Assignment (Level 2 - Other analytes) | For Chloride, Glucose (Oxidase/Hexokinase), Lactate, Sodium: %CV 3%, % Recovery error 5%, with specific percentage ranges applied (15% for Glucose/Lactate, 5% for Sodium, 10% for Chloride). For Immunoglobulin G: %CV 10%, % Recovery error 10%, 25% percentage range applied. For Protein Total: %CV 5%, % Recovery error 5%, 20% percentage range applied. | Target values and acceptable ranges are provided. The study implies results for precision (%CV) and recovery error were within these criteria during value assignment. Chloride: Target 86.8, Range 78.1 - 95.5 Glucose Oxidase: Target 3.11, Range 2.64 - 3.58 Glucose Hexokinase: Target 2.85, Range 2.42 - 3.28 Immunoglobulin G: Target 25.3, Range 19.0 - 31.6 Lactate: Target 0.38, Range 0.32 - 0.44 Protein Total: Target 0.235, Range 0.188 - 0.282 Sodium: Target 127, Range 121 - 133 |
| Value Assignment (Level 3 - Electrophoresis analytes) | For Albumin: Percentage Range Applied (%) 10% (53.1-64.9). For Alpha-1-globulin, Alpha-2-globulin, Beta-globulin, Gamma-globulin: Percentage Range Applied (%) 25%. | Target values and acceptable ranges are provided for each analyte. The study implies that target values are successfully assigned and fall within these specified ranges. Albumin: Target 59.0, Range 53.1-64.9 Alpha-1-globulin: Target 2.4, Range 1.8-3.0 Alpha-2-globulin: Target 7.4, Range 5.5-9.3 Beta-globulin: Target 6.9, Range 5.2-8.6 Gamma-globulin: Target 24.3, Range 18.23-30.4 |
| Value Assignment (Level 3 - Other analytes) | For Chloride, Glucose (Oxidase/Hexokinase), Lactate, Sodium: %CV 3%, % Recovery error 5%, with specific percentage ranges applied (15% for Glucose/Lactate, 5% for Sodium, 10% for Chloride). For Immunoglobulin G: %CV 10%, % Recovery error 10%, 25% percentage range applied. For Protein Total: %CV 5%, % Recovery error 5%, 20% percentage range applied. | Target values and acceptable ranges are provided. The study implies results for precision (%CV) and recovery error were within these criteria during value assignment. Chloride: Target 110, Range 99-121 Glucose Oxidase: Target 5.81, Range 4.94-6.68 Glucose Hexokinase: Target 5.53, Range 4.70-6.64 Immunoglobulin G: Target 70.3, Range 52.7-87.9 Lactate: Target 3.93, Range 3.34-4.64 Protein Total: Target 0.489, Range 0.391-0.587 Sodium: Target 169, Range 161-177 |
2. Sample Size Used for the Test Set and Data Provenance
- Open Vial Stability: For open vial stability, a "set" of CSF Controls Levels 2 and 3 was used. On day 14, a "fresh sample" was reconstituted and compared. This implies at least two reconstituted vials (one fresh, one 14-day aged) for comparison for each control level, and "replicates" were performed, though the specific number of replicates is not stated.
- Shelf Life (Real-time Stability): For real-time stability, "10 sets of each control" (Level 2 and Level 3) were used. This means 10 vials of Level 2 and 10 vials of Level 3 were stored at ultra-frozen conditions, and another 10 vials of Level 2 and 10 vials of Level 3 were stored at routine temperature (2-8°C).
- Value Assignment: "Several replicates" were used for both electrophoresis measurements and for the remaining analytes, but the exact number of replicates is not specified.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given that it's a submission for a new device manufactured by Randox Laboratories Limited in the United Kingdom, it's highly probable the studies were conducted prospectively by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document describes the establishment of target values for the control material (which serves as the "ground truth" for quality control purposes).
- For electrophoresis analytes, vials were "analyzed at an external site." The number of experts or the specific qualifications of those performing the analysis are not explicitly stated, but it's implied that these are qualified professionals at a specialized laboratory.
- For other analytes, comparison was made against a "master lot." This does not involve human expert interpretation in the same way as, for example, image analysis.
4. Adjudication Method for the Test Set
- Adjudication methods like 2+1 or 3+1 typically apply to studies where human interpretation of results is involved and discrepancies need to be resolved.
- For laboratory control materials, the "ground truth" (target values and acceptable ranges) is established through analytical processes and statistical analysis of multiple replicates. Discrepancies would be resolved by re-running samples, checking instrument calibration, or investigating analytical issues, rather than through expert adjudication in the human-reader sense. The value assignment methods described involve calculating means of "several replicates" and comparing against established criteria, implicitly handling variability through statistical methods rather than human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
- This device is a quality control material for in vitro diagnostic tests, not an algorithm or imaging device that requires human interpretation or comparison of human reader performance. The studies focus on the analytical performance (stability, value assignment) of the control material itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This device is a quality control material, not an algorithm. Therefore, a standalone performance study (in the context of an algorithm's performance independent of human input) is not applicable or described. The performance studies focus on the intrinsic properties and stability of the control material.
7. The Type of Ground Truth Used
- The ground truth for this device (Randox CSF Controls) is its assigned target values and acceptable ranges for various analytes.
- This ground truth is established through:
- Analytical Testing and Expert Consensus (implicit for electrophoresis): For electrophoresis analytes (Albumin, Alpha-1-globulin, etc.), the mean of "several replicates" analyzed at an external site is taken, and percentages of total protein are calculated. This implies the analytical results from a qualified external lab are considered the definitive "ground truth."
- Comparison to a Master Lot and Analytical Testing: For other analytes (Chloride, Glucose, Immunoglobulin G, Lactate, Sodium, Total Protein), the test controls are assessed against a "master lot" using analytical methods. The mean of several replicates and CV are calculated, and recovery of the master lot is measured against predefined acceptance criteria.
8. The Sample Size for the Training Set
- The concept of a "training set" is typically associated with machine learning algorithms.
- For this quality control material, there isn't a "training set" in that sense. The manufacturing process and formulation are developed, and then the stability and value assignment studies (described above) act as validation and characterization. The "master lot" mentioned in value assignment method 2 could be considered a reference or calibration standard that helps establish the "ground truth" for new lots, but it's not a training set for an AI model.
9. How the Ground Truth for the Training Set Was Established
- As there is no "training set" in the context of an algorithm for this device, this question is not fully applicable.
- However, if we interpret "ground truth for the training set" as the basis for establishing the expected values for the control material, it's established through:
- Reference materials and methods: For individual analytes, traceable sources are used, such as "Synthetic Analytical Grade chemical" from commercial suppliers (e.g., SIGMA, EUROPA) or biological materials "derived from Human serum" (e.g., Intergen).
- Comprehensive analytical testing: As described in section 9 "Summary of Value Assignment," extensive laboratory analysis involving "several replicates" and comparison to a master lot or external site analysis is performed to determine the "Target Value" and "Acceptable range" for each analyte.
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K/32/56
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: Pauline Armstrong
Address: Randox Laboratories Limited, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom.
OCT 2 3 2013
Telephone: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 E-mail: Pauline.Armstrong@randox.com
3. 510k NUMBER, DEVICE PROPRIETARY NAME, COMMON NAME, PURPOSE FOR SUBMISSION, REGULATORY CLASSIFCATION, PANEL. PRODUCT CODE AND 21 CFR NUMBER
510k No: K132156
Device Proprietary Name: Randox CSF Controls Levels 2 and 3
Common Name: Randox CSF Controls Levels 2 and 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:
Roche PreciControl PUC (Proteins in Urine/CSF) norm and PreciControl PUC path
510 (k) Number: K040280
5. INTENDED USE
The Randox CSF Controls Levels 2 and Level 3 are intended for in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for Clinical Chemistry systems. This device is intended for prescription use only.
6. DEVICE DESCRIPTION
The Randox CSF controls consist of a buffered aqueous solution with biological materials; they are supplied at 2 levels, level 2 and 3.
Target values and ranges are supplied for the following analytes at both levels: Chloride, Glucose, IgG, Lactic Acid, Sodium, Total Protein (Pyrogallol Red), and % Total Protein quoted for Electrophoresis regions at both levels: Albumin, Alpha-1-Globulin, Alpha-2-Globulin, Beta Globulin and Gamma Globulin.
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7. PREDICATE DEVICE COMPARISON TABLE
:
COMPARISON OF RANDOX CSF CONTROLS LEVELS 2 AND 3 WITH THE PREDICATE DEVICE
| Similarities | ||
|---|---|---|
| CHARACTERISTICS | RANDOX CSF CONTROLS LEVELS 2 and 3 | Roche Precinorm PUCPrecipath PUCK040280 |
| INTENDED USE | Intended for in vitro diagnostic use as assayed quality control material for diagnostic methods using CSF sample on clinical chemistry systems. | Precinorm/path PUC (Proteins in Urine/CSF) is used for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheet |
| STORAGE(Unopened) | Stable until expiry date unopened and stored at 2-8°C. | Same |
| MATRIX | Buffered Aqueous Base with Biological Materials added as required to obtain desired component levels in either the normal or pathological range | Same |
| SIZE | 3ml | Same |
| Differences | ||
|---|---|---|
| CHARACTERISTICS | RANDOX CSF CONTROLSLEVELS 2 and 3 | Roche Precinorm PUC PrecipathPUCK040280 |
| FORMAT | Lyophilised | Liquid |
| OPEN VIAL CLAIM | Stable for 14 days after opening cappedand stored at 2-8°C | Stable for 4 weeks after opening cappedand stored at 2-8°C |
| Constituent Analytes | AlbuminAlpha-1-globulinAlpha-2-globulinBeta-globulinGamma-globulinChlorideGlucoseImmunoglobulin GLactateProtein TotalSodium | AlbuminCreatinineTotal ProteinUrine/CSF Protein |
.
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8. SUMMARY OF STABILITY STUDIES
Open vial stability of the Randox CSF controls levels 2 and 3 was assessed by opening a set of CSF Controls levels 2 and 3 and reconstituting them according to the package insert. The current open vial stability is 14 days. Once reconstituted the material was stored at + 2 - 8°C for 14 days. On day 14 a fresh sample was reconstituted and compared to the reconstituted vial stored at + 2 - 8°C for 14 days. The mean of the replicates and the percentage deviation of the 14 day reconstituted vial to the fresh vial are calculated.
The acceptance criteria state the percentage deviation of reconstituted to fresh should be ± 3%.
The table below shows the summary of the open vial stability. Open vial stability is assessed for Chloride, Glucose, Lactate, Sodium and Protein Total only as albumin, alpha-1, alpha-2, beta and gamma globulin and immunoglobulin G are all calculated as a percentage of the total protein.
Results
| Control | Lot number | Reconstituted Stability |
|---|---|---|
| Randox CSF ControlLevel 2 | 059CF | 14 days |
| Randox CSF ControlLevel 3 | 060CF | 14 days |
The data demonstrates that the Randox CSF controls levels 2 and 3 are stable for 14 days reconstituted and stored at + 2 - 8°C for 14 days.
Shelf life for the Randox CSF controls levels 2 and 3 was assessed by realtime stability studies. Once a new batch of Randox CSF controls levels 2 and 3 are manufactured 10 sets of each control are stored unopened at ultra frozen conditions -75 to 90°C and another 10 are stored unopened at the routinely stored temperature of + 2 - 8°C. The results of the routinely stored are compared to the ultra frozen.
The acceptance criteria states the control recovery for routinely stored compared to ultra-frozen should be within ± 15% deviation.
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The following table shows the summary of real time stabilities.
In some cases the real time stability is assessed for protein total only as albumin, alpha-1, alpha-2, beta and gamma globulin and immunoglobulin G are all calculated as a percentage of the total protein.
Results
| Randox CSF Controls CF1500-CF1501 | |
|---|---|
| Randox CSF Control Level 2 | |
| Lot number | Real-time tested and passed |
| 038CF | 37 months |
| Randox CSF Control Level 3 | |
| Lot number | Real-time tested and passed |
| 035CF | 37 months |
The data demonstrates that the Randox CSF controls levels 2 and 3 are stable for 37 months from the date of manufacture. This meets the current shelf life stability claim of 3 years and exceeds this by 1 month.
9. SUMMARY OF VALUE ASSIGNMENT
Value assignment is used to calculate a target value for the Randox CSF Controls levels 2 and 3. The Randox CSF controls are used to measure various analytes including albumin, alpha-1-globulin, alpha-2-globulin, beta globulin, gamma globulin, chloride, glucose, immunoglobulin G, lactate, total protein and sodium. There are two methods of value assignment applied depending on the analyte being measured.
Value assignment method 1:
Electrophoresis is the method used to assign a target value for albumin, apha-1globulin, alpha-2 globulin, beta-globulin and gamma globulin. Once a new lot of CSF controls are manufactured vials are analyzed at an external site. The mean of several replicates is taken, the total protein value is set at 100% and the fraction of each of the individual proteins calculated as a percentage of the total protein. The calculated % of the total protein is used as the target value for the labeling and a range applied dependent on the protein being measured. Please refer to the following tables.
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Value assignment method 2:
The remaining analytes (chloride, glucose, immunoglobulin G, lactate, and sodium) are assigned a target value and assessed against the master lot. Several replicates of the test controls are assessed and the mean and CV calculated. The recovery of the master lot is also measured.
The acceptance criteria is dependent upon the analyte being assigned. Typically the precision is measured by the CV for the master and test lots and the recovery of the master lot is measured. A target value is assigned and a range applied that is dependent on the analyte being measured. Please refer to the following tables.
| Analyte | Unit | TargetValue | PercentageRangeApplied (%) | Acceptablerange | %CV | % Recovery error |
|---|---|---|---|---|---|---|
| Albumin(electrophoresis) | N/A | 59.9 | 10 | 53.9 - 65.9 | N/A | N/A |
| Alpha-1-globulin(electrophoresis | N/A | 2.0 | 25 | 1.5 – 2.5 | N/A | N/A |
| Alpha-2-globulin(electrophoresis) | N/A | 4.6 | 25 | 3.5 - 5.8 | N/A | N/A |
| Beta-globulin(electrophoresis) | N/A | 5.3 | 25 | 4.0 - 6.6 | N/A | N/A |
| Gamma-globulin | N/A | 28.3 | 25 | 21.2 - 35.4 | N/A | N/A |
| Chloride | mmol/l | 86.8 | 10 | 78.1 - 95.5 | 3 | 5 |
| Glucose Oxidase | mmol/l | 3.11 | 15 | 2.64 - 3.58 | 3 | 5 |
| GlucoseHexokinase | mmol/l | 2.85 | 15 | 2.42 - 3.28 | 3 | 5 |
| Immunoglobulin G | mg/l | 25.3 | 25 | 19.0 - 31.6 | 10 | 10 |
| Lactate | mmol/l | 0.38 | 15 | 0.32 - 0.44 | 3 | 5 |
| Protein Total | g/l | 0.235 | 20 | 0.188 - 0.282 | 5 | 5 |
| Sodium | mmol/l | 127 | 5 | 121 - 133 | 3 | 5 |
RANDOX CSF CONTROL LEVEL 2 VALUE ASSIGNMENT CRITERIA
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| Analyte | Unit | TargetValue | PercentageRangeApplied (%) | Acceptablerange | %CV | % Recoveryerror |
|---|---|---|---|---|---|---|
| Albumin(electrophoresis) | N/A | 59.0 | 10 | 53.1-64.9 | N/A | N/A |
| Alpha-1-globulin(electrophoresis) | N/A | 2.4 | 25 | 1.8-3.0 | N/A | N/A |
| Alpha-2-globulin(electrophoresis) | N/A | 7.4 | 25 | 5.5-9.3 | N/A | N/A |
| Beta-globulin(electrophoresis) | N/A | 6.9 | 25 | 5.2-8.6 | N/A | N/A |
| Gamma-globulin | N/A | 24.3 | 25 | 18.23-30.4 | N/A | N/A |
| Chloride | mmol/l | 110 | 10 | 99-121 | 3 | 5 |
| Glucose Oxidase | mmol/l | 5.81 | 15 | 4.94-6.68 | 3 | 5 |
| GlucoseHexokinase | mmol/l | 5.53 | 15 | 4.70-6.64 | 3 | 5 |
| Immunoglobulin G | mg/l | 70.3 | 25 | 52.7-87.9 | 10 | 10 |
| Lactate | mmol/l | 3.93 | 15 | 3.34-4.64 | 3 | 5 |
| Protein Total | g/l | 0.489 | 20 | 0.391-0.587 | 5 | 5 |
| Sodium | mmol/l | 169 | 5 | 161-177 | 3 | 5 |
RANDOX CSF CONTROL LEVEL 3 VALUE ASSIGNMENT CRITERIA
10. TRACEABILITY
| ANALYTE | SUPPLIER | PRODUCTNUMBER | ORIGIN | SOURCE |
|---|---|---|---|---|
| Glucose | SIGMA | G8270 | Synthetic AnalyticalGrade chemical | Commercial source, added volumetrically |
| Lactic Acid | EUROPA | UBL7016 | Synthetic AnalyticalGrade chemical | Commercial source, added volumetrically |
| Chloride | SIGMA | 59888 | Synthetic AnalyticalGrade chemical | Commercial source, added volumetrically |
| Sodium | SIGMA | 59888/56014 | Synthetic AnalyticalGrade chemical | Commercial source, added volumetrically |
| Albumin, alpha-1-globulin,alpha-2-globulin, beta-globulin, immunoglobulin G,total protein-proteins allderived from Human serum | Intergen | Received undera lot number | Human | Human source |
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/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three swooping lines representing the agency's mission to protect and promote the health and well-being of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2013
RANDOX LABORATORIES, LTD. c/o Dr. Pauline Armstrong 55 Diamond Rd. CRUMLIN, COUNTY ANTRIM BT29 4QY UK
Re: K132156
Trade/Device Name: Randox CSF Controls Levels 2 and 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, reserved Product Code: JJY Dated: September 6, 2013 Received: September 9, 2013
Dear Dr. 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.
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Page 2-Dr. Armstrong
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/ReportalProblem/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.
Carol Benson -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
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Indications for Use .
510(k) Number (if known): K132156
Device Name: Randox CSF Controls Levels 2 and 3
Indication for Use:
The Randox CSF Controls Levels 2 and 3 are intended for in vitro diagnostic use as assayed quality control material to monitor the precision of diagnostic methods using CSF as a sample on clinical chemistry systems.
This in vitro diagnostic device is intended for prescription use only.
Prescription Use f And/Or (21 CFR Part 801 Subpart D)
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)
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Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K132156
§ 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.