(79 days)
This product is intended for in vitro diagnostic use as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert.
Randox Immunoassay Premium Plus Controls are manufactured at three levels, Level 1, Level 2 and Level 3. The materials are supplied as Level 1, Level 2 , Level 3 and a Tri-Level configuration. Each 5 ml vial of lyophilized serum is reconstituted with exactly 5 ml of distilled water at +20 to 25° C.
The base matrix used for the manufacture of Randox Immunoassay Premium Plus Controls is Human Serum with added chemicals.
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 accordinaly.
This document describes the stability studies conducted for the Randox Immunoassay Premium Plus Controls Levels 1, 2, and 3, and the Immunoassay Premium Plus Tri-Level Control. These studies establish the acceptance criteria for various stability conditions and demonstrate the device's performance against these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Study Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Open Vial Stability (General) | Percentage deviation of reconstituted to fresh should be ≤10%. | All analytes (excluding C-Peptide, Thyroglobulin, ACTH, and PTH) in all control levels (1, 2, 3, and Tri-Level) passed the stability test at Day 7 when stored at +2 to +8°C. |
| Open Vial Stability (C-Peptide) | Percentage deviation of reconstituted to fresh should be ≤10%. | C-Peptide in all control levels (1, 2, 3, and Tri-Level) passed the stability test at Day 1 when stored at +2 to +8°C. |
| Open Vial Stability (ACTH, Thyroglobulin, PTH) | Percentage deviation of reconstituted to fresh should be ≤10%. | ACTH, Thyroglobulin, and Parathyroid Hormone (PTH) in all control levels (1, 2, 3, and Tri-Level) passed the stability test at 4 hours when stored at +2 to +8°C. |
| Frozen Stability | Percentage deviation of reconstituted to fresh should be ≤10%. (No claim for ACTH, Aldosterone, C-Peptide) | All analytes (excluding ACTH, Aldosterone, and C-Peptide) in all control levels (1, 2, 3, and Tri-Level) passed the stability test after 4 weeks (28 days) when stored at -18 to -24°C. |
| Accelerated Stability | Percentage deviation to fresh should be ≤10%. | All analytes in all control levels (1, 2, 3, and Tri-Level) passed the accelerated stability test at Week 4 (after storage at elevated temperatures: 28-32 °C, 35-39 °C, and 43-47 °C). This supported a predicted shelf life of 3 years. |
| Real Time Stability | Percentage deviation to controls stored at the routine temperature should be ≤10%. | Current Real Time studies (monitoring controls stored at -75 to -90°C against controls stored at +2 to +8°C at various timepoints) support a 3-year shelf life for all control levels (1, 2, 3, and Tri-Level). The document explicitly states "Current Real Time studies support a 3 year shelf life," implying that the acceptance criteria of ≤10% deviation were met. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For open vial stability, frozen stability, and real-time/accelerated stability, the studies were conducted using a "set" of Immunoassay Premium Plus Controls levels 1, 2 & 3.
- Specific lot numbers were used: 972EC, 974EC, 977EC for the individual levels and combination for the Tri-Level control for open vial and frozen stability.
- For accelerated and real-time stability, lot numbers 852EC/941EC, 854EC/943EC, and 857EC/946EC were used.
- The document does not specify the number of individual vials or replicates tested within each lot for these stability studies.
- Data Provenance: The studies were conducted by Randox Laboratories Limited, based in Crumlin, County Antrim, United Kingdom. The data is prospective, as these are stability studies conducted to support the device's shelf life and claims.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This device is an in vitro diagnostic quality control material, not an imaging or diagnostic algorithm that relies on expert interpretation of images or clinical data. Therefore, the concept of "experts" establishing a ground truth for a test set in the conventional sense (e.g., radiologists, pathologists) does not directly apply here.
For the Value Assignment (Section 9), which can be considered analogous to establishing "ground truth" for the analyte concentrations within the control material:
- Number of Participants: "Each batch of Immunoassay Premium Plus is submitted to a number of external laboratories" and/or by in-house testing. The exact number of external laboratories is not specified.
- Qualifications of Participants: The document does not specify the qualifications of the personnel or laboratories involved in the value assignment process, beyond stating they are "external laboratories" and "in-house testing." However, for diagnostic control materials, these would typically be certified clinical reference laboratories or laboratories adhering to recognized quality standards for analytical testing.
4. Adjudication Method for the Test Set
For Value Assignment (Section 9):
- Method: Statistical analysis, including the mean, SD, and %CV, were calculated from the results obtained by these laboratories. An assigned value is derived from the mean specific value, and an analyte-specific percentage range is applied. This suggests a form of consensus-based adjudication among the participating laboratories, where the mean value plays a central role.
For Stability Studies:
- Method: The adjudication method for stability studies is direct comparison against predefined acceptance criteria (percentage deviation of ≤10% from fresh or routine controls). This is a direct analytical measurement comparison rather than expert consensus on individual results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study (MRMC) is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret cases, and the study aims to quantify the effect of an AI tool on their performance. The Randox Immunoassay Premium Plus Controls are in vitro diagnostic quality control materials, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not applicable.
6. Standalone Performance Study
Yes, the stability studies (open vial, frozen, accelerated, and real-time stability) described are standalone assessments of the device's performance (specifically its stability) under various conditions. These studies rigorously evaluate the control material itself without human intervention in the performance measurement, beyond handling according to instructions. The value assignment also represents a standalone assessment of the control's intended values.
7. Type of Ground Truth Used
- For Stability Studies: The "ground truth" for stability is established through reference measurements against freshly reconstituted or routinely stored control materials. The acceptance criterion is a predefined percentage deviation (≤10%) from these reference measurements.
- For Value Assignment: The "ground truth" for the assigned analyte values is established by a consensus of results obtained from multiple external laboratories and/or in-house testing, applying statistical analysis (mean, SD, %CV).
8. Sample Size for the Training Set
This document does not describe a "training set" in the context of machine learning. The device is a physical in vitro diagnostic control material, not a software algorithm that is "trained" on data. The manufacturing process and quality control procedures ensure the consistency and performance of the product.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no "training set" for this device in the conventional sense. The "ground truth" for the assigned values of the control material (which might be analogous to what a "training set" would establish for an AI model) is established through the consensus of results from multiple laboratories and statistical analysis as described in Section 9 of the document.
{0}------------------------------------------------
MAY 2 2 2014
Image /page/0/Picture/1 description: The image shows the word "RANDOX" in all capital letters. The font is bold and sans-serif. The letters are black against a white background.
510 (k) Summarv Randox Immunoassay Premium Plus Controls Levels 1, 2 and 3, KJYJSZ 2 Immunoassay Premium Plus Tri-Level Control
- 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: May 15, 2014
- 510k NUMBER, DEVICE PROPRIETARY NAME, COMMON NAME, PURPOSE FOR SUBMISSION, REGULATORY CLASSIFCATION, PANEL, PRODUCT CODE AND 21 CFR NUMBER
510k No: K140522
Device Proprietary Name: Randox Immunoassay Premium Plus Controls Levels 1, 2 & 3, Immunoassay Premium Plus Tri-Level Control.
Common Name: Randox Immunoassay Premium Plus Controls Levels 1, 2 & 3, Immunoassay Premium Plus Tri-Level Control.
Purpose for Submission: New Device
Regulatory Classification: Multi-analyte Controls, All kinds (Assayed and Unassayed)
Classification: Class 1. Reserved
Panel: Clinical Chemistry
Product Code: JJY 21 CFR Number: 21 CFR 862.1660
1 | Page
{1}------------------------------------------------
RANDOX
510 (k) Summary Randox Immunoassay Premium Plus Controls Levels 1, 2 and 3, Immunoassay Premium Plus Tri-Level Control
4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS
Predicate Device Proprietary Name: Randox Immunoassay Controls Levels 1, 2 and 3
510 (k) Numbers: K040379
5. INTENDED USE
This product is intended for in vitro diagnostic use as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert.
6. DEVICE DESCRIPTION
Randox Immunoassay Premium Plus Controls are manufactured at three levels, Level 1, Level 2 and Level 3. The materials are supplied as Level 1, Level 2 , Level 3 and a Tri-Level configuration. Each 5 ml vial of lyophilized serum is reconstituted with exactly 5 ml of distilled water at +20 to 25° C.
The base matrix used for the manufacture of Randox Immunoassay Premium Plus Controls is Human Serum with added chemicals.
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 accordinaly.
{2}------------------------------------------------
RAND◎X
510 (k) Summary Randox Immunoassay Premium Plus Controls Levels 1, 2 and 3, Immunoassay Premium Plus Tri-Level Control
7. PREDICATE DEVICE COMPARISON TABLE
TABLE 1: COMPARISON OF RANDOX IMMUNOASSAY PREMIUM PLUS CONTROLS LEVELS 1, 2 AND 3 WITH THE PREDICATE DEVICE
| CHARACTERISTICS | RANDOX IMMUNOASSAY PREMIUMPLUS CONTROLS LEVELS 1, 2 AND 3( New Device ) | RANDOX IMMUNOASSAY CONTROLSLEVELS 1, 2 AND 3K040379( Predicate Device ) |
|---|---|---|
| INTENDED USE | This product is intended for in vitrodiagnostic use as assayed quality controlmaterial to monitor the accuracy andreproducibility of analytes listed in thepackage insert. | The Randox Immunoassay ControlsLevels 1, 2 and 3 are intended for in vitrodiagnostic use in the quality control ofImmunoassays on clinical chemistry andImmunoassay systems. |
| FORMAT | Lyophilised | Lyophilised |
| MATRIX | Human Serum | Human Serum |
| ANALYTES | 49 Analytes25-OH Vitamin D, ACTH, AFP,Aldosterone(Levels 2 & 3 only), Amikacin,Androstenedione, Beta-2 Microglobulin, C-Peptide,CA15-3, CA19-9, CA125, Carbamazepine, CEA,Cortisol, DHEA-S, Digoxin, Ferritin, Folate, Free T3,Free T4, FSH, Gentamicin, GH, IgE, Insulin, LH,Oestradiol, Paracetamol, PTH, Phenytoin, Primodone,Progesterone, Prolactin, PSA Free, PSA Total, SalicylicAcid, SHBG, T-Uptake, Testosterone, Theophylline,Thyroglobulin, TSH, Tobramycin, Total Beta hCG, TotalT3, Total T4, Valproic Acid, Vancomycin, Vitamin B12. | 33 AnalytesAFP, Beta-2 Microglobulin, CA15-3, CA19-9, CA125,Carbamazepine, CEA, Cortisol, DHEA-S, Digoxin,Ferritin, Folate, Free T3, Free T4 FSH, GH, IgE, LH,Oestradiol, 17-OH-Progesterone, Phenytoin,Progesterone, Prolactin, PSA Free, PSA Total,Testosterone, Theophylline, TSH, Tobramycin, TotalBeta hCG, Total T3, Total T4, Valproic Acid, Vitamin B12. |
| STORAGE(Unopened) | 2 to 8 °CUntil expiration date | 2 to 8 °CUntil expiration date |
| OPEN VIAL CLAIM | Reconstituted serum is stable for 7 daysat +2°C to +8°C if kept capped in originalcontainer and free from contamination or4 weeks frozen once at -20°C. C-Peptide is stable for 1 day at+2°C to +8°C. Parathyroid hormone(PTH) and Thyroglobulin should be testedwithin 4 hours of reconstitution, whenstored at +2°C to +8°C or within 2 weekswhen stored at -20°C. ACTH should beassayed within 4 hours of reconstitution,when stored at +2°C to +8°C. | Reconstituted serum is stable for 7 daysat +2°C to +8°C if kept capped in originalcontainer and free from contamination or4 weeks frozen once at -20°C. The PSAin this sera will be stable for 2 days at+2°C to +8°C. |
| SIZE | 12 x 5ml | 10 x 5ml |
| SHELF LIFE | 36 months | 36 months |
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the word "RANDOX" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The word appears to be a logo or brand name.
510 (k) Summary Randox Immunoassay Premium Plus Controls Levels 1, 2 and 3, Immunoassay Premium Plus Tri-Level Control
8. SUMMARY OF STABILITY STUDIES
Open vial stabiltiy
Open vial stability of the Randox Immunoassay Premium Plys Controls levels 1, 2 & 3 was assessed by opening a set of Immunoassay Premium Plus Controls levels 1, 2 & 3 and reconstituting them according to the package insert. Samples were reconstituted and stored at +2 to +8°C for 7 days and tested for the quoted analytes except C-Peptide stable for 1 day, Thyroglobulin, ACTH and Parathyroid hormone (PTH) should be tested within 4 hours of reconstitution.
The acceptance criteria state the percentage deviation of reconstituted to fresh should be ≤10%.
The tables below show the summary of the open vial stability.
Results
Reconstituted Stability Day 7
| Control | Lotnumber | Reconstituted Stability at Day 7 |
|---|---|---|
| Randox Immunoassay Premium PlusControl levels 1 | 972EC | All analytes pass |
| Randox Immunoassay Premium PlusControl levels 2 | 974EC | All analytes pass |
| Randox Immunoassay Premium PlusControl levels 3 | 977EC | All analytes pass |
| Randox Immunoassay Premium PlusTri-Level Control | 972EC,974EC,977EC | All analytes pass |
Reconstituted Stability Day 1 for C-Peptide
| Control | Lotnumber | Reconstituted Stability at Day 1 |
|---|---|---|
| Randox Immunoassay Premium PlusControl levels 1 | 972EC | Pass |
| Randox Immunoassay Premium PlusControl levels 2 | 974EC | Pass |
| Randox Immunoassay Premium PlusControl levels 3 | 977EC | Pass |
| Randox Immunoassay Premium PlusTri-Level Control | 972EC,974EC,977EC | Pass |
{4}------------------------------------------------
RANDOX
510 (k) Summary Randox Immunoassay Premium Plus Controls Levels 1, 2 and 3, Immunoassay Premium Plus Tri-Level Control
Reconstituted Stability 4 Hours for ACTH, Thyroglobulin & Parathyroid Hormone.
| Control | Lot number | Reconstituted Stability at 4 Hours |
|---|---|---|
| Randox ImmunoassayPremium Plus Controllevels 1 | 972EC | All analytes pass |
| Randox ImmunoassayPremium Plus Controllevels 2 | 974EC | All analytes pass |
| Randox ImmunoassayPremium Plus Controllevels 3 | 977EC | All analytes pass |
| Randox ImmunoassayPremium Plus Tri-LevelControl | 972EC, 974EC,977EC | All analytes pass |
The data demonstrates that the Randox Immunoassay Premium Plus Controls levels 1, 2 & 3 are stable for 7 days reconstituted and stored at + 2 - 8ºC. C-Peptide is stable for 1 day at +2℃ to +8℃. Parathyroid hormone (PTH) Thyroglobulin and ACTH should be tested within 4 hours of reconstitution, when stored at +2°C to +8°C
Frozen stabiltiy
Frozen stability of the Randox Immunoassay Premium Plus Controls levels 1, 2 & 3 was assessed by opening a set of Immunoassay Premium Plus Controls levels 1, 2 & 3 and reconstituting them according to the package insert. Samples were reconstituted and stored at -18 to -24°C for 28 days. After this period, the controls were thawed and a fresh vial was tested alongside the stability vials.
The acceptance criteria state the percentage deviation of reconstituted to fresh should be ≤10%. No frozen stability claim is made for ACTH, Aldosterone and C-Peptide.
{5}------------------------------------------------
RANDOX
510 (k) Summary Randox Immunoassay Premium Plus Controls Levels 1, 2 and 3, Immunoassay Premium Plus Tri-Level Control
The table below shows the summary of the Frozen stability
Frozen stability after 4 weeks at -20°C
| Control | Lot number | Reconstituted Stability at Day 7 |
|---|---|---|
| Randox ImmunoassayPremium Plus Controllevels 1 | 972EC | All analytes pass |
| Randox ImmunoassayPremium Plus Controllevels 2 | 974EC | All analytes pass |
| Randox ImmunoassayPremium Plus Controllevels 3 | 977EC | All analytes pass |
| Randox ImmunoassayPremium Plus Tri-LevelControl | 972EC, 974EC,977EC | All analytes pass |
The data demonstrates that the Randox Immunoassay Premium Plus Controls levels 1, 2 & 3 are stable for 28 days reconstituted and stored frozen at -18 to -24°C. No frozen stability claim is made for ACTH. Aldosterone and C-Peptide.
Real Time Testing & Accelerated Stability Testing
Accelerated stability was used to predict the shelf life of control materials. The Randox Immunoassay Premium Plus Controls levels 1, 2 & 3 were stored at elevated temperature for a period of four weeks. Following storage at the elevated temperature (28-32 °C, 35-39 °C and 43-47 °C), the accelerated stability control is then tested alongside a fresh control and the percentage deviation is calculated
The acceptance criteria state the percentage deviation to fresh should be ≤10%.
The shelf life of these products was set at 3 years from the date of manufacture, based on the performance of the accelerated stability testing.
The real time stability of the controls was monitored to verify and validate the predicted or desirable shelf life.
The Randox Immunoassay Premium Plus Controls 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 +2 to +8°C at various timepoints and the percentage deviation is calculated.
The acceptance criteria state the percentage deviation to controls stored at the routine temperature should be ≤10%.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the word "RANDOX" in a bold, sans-serif font. The letters are black against a white background. The "O" in "RANDOX" is stylized with a circle inside of a circle.
510 (k) Summary Randox Immunoassay Premium Plus Controls Levels 1, 2 and 3, Immunoassay Premium Plus Tri-Level Control
Current Real Time studies support a 3 year shelf life.
The table below shows the summary of the accelerated stability and real time testing.
Accelerated stability and Real time testing
| Control | Lotnumber | AcceleratedStability | Real timetesting |
|---|---|---|---|
| Randox ImmunoassayPremium Plus Controllevels 1 | 852EC/941EC | All analytes passat Week 4 | 36 Months |
| Randox ImmunoassayPremium Plus Controllevels 2 | 854EC/943EC | All analytes pass atWeek 4 | 36 Months |
| Randox ImmunoassayPremium Plus Controllevels 3 | 857EC/946EC | All analytes pass atWeek 4 | 36 Months |
| Randox ImmunoassayPremium Plus Tri-LevelControl | 852/941EC,854/943EC,857/946EC | All analytes pass atWeek 4 | 36 Months |
9. SUMMARY OF VALUE ASSIGNMENT
Each batch of Immunoassay Premium Plus is submitted to a number of external laboratories and values are assigned from a consensus of 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 mean specific value and an analyte specific 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.
10. CONCLUSION
Testing results indicate that the proposed device is substantially equivalent to the predicate device.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gf Silver Spring, MD 20993-0002
May 22, 2014
RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG QA/RA MANAGER 55 DIAMOND RD. CRUMLIN, CO. ANTRIM BT29 40Y, UK
Re: K140522
Trade/Device Name: Randox Immunoassay Premium Plus Control Levels 1.2 & 3 Immunoassay Premium Plus Tri-level Control
Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I. Reserved Product Code: JJY Dated: April 01. 2014 Received: April 4, 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 11 (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 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.
{8}------------------------------------------------
Page 2-Dr. Pauline Armstrong
If you desire specific advice for your device on our labeling regulations (2) 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/Resources/orYou/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 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/Industrv/default.htm.
Sincercly yours.
Courtney H. Lias -S
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
{9}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Immunoassay Premium Plus Controls Levels 1, 2 & 3, Immunoassay Premium Plus Tri-Level Control.
Indications for Use (Describe)
This product is intended for in vitro diagnostic use as assayed quality control materials to monitor the accuracy and reproducibility of the analytes listed in the package insert.
This in vitro diagnostic device is intended for prescription use only.
Type of Use (Select one or both, as applicable)
V Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Yung W. Chan -S
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 Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 Sec PRA Statement below.
§ 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.