(27 days)
No
The device description and performance studies focus on chemical calibrators and controls for drug testing, with no mention of AI or ML algorithms.
No
This device is an in vitro diagnostic (IVD) device used for calibrating and controlling analytical instruments for drug testing in human urine, not for treating a disease or condition.
Yes
Explanation: The device is explicitly stated as "This in vitro diagnostic device" in both the "Intended Use / Indications for Use" and "Device Description" sections.
No
The device is a set of liquid calibrators and controls, which are physical substances used in laboratory testing, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "This in vitro diagnostic device is intended for prescription use only."
- Device Description: The "Device Description" section also states: "Randox Benzodiazepine Calibrators and Controls have been designed for in vitro diagnostic use only."
- Intended Use: The device is intended for use in the calibration and quality control of Benzodiazepine assays on specific analysers (RX series) using human urine samples. This is a typical application for in vitro diagnostics, which are used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Predicate Device: The mention of a predicate device (K051088; Lin-Zhi International, Inc, LZI Multiple Analyte Urine Drugs of Abuse Calibrators and Controls) which is also an IVD, further supports the classification of this device as an IVD.
N/A
Intended Use / Indications for Use
Randox Benzodiazepine Calibrator Set
The Randox Benzodiazepine Calibrator set consists of liquid calibrators containing Oxazepam. There are 5 levels of calibrator. They have been developed for use in the calibration of the RX series analysers in human urine, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.
Randox Benzodiazepine Controls Level 1 & 2
The Randox Benzodiazepine Controls are liquid controls containing Oxazepam. There are 2 levels of controls. They have been developed for use in the quality control and validation of Benzodiazepine assay on the RX series analysers in human urine, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
DLJ, LAS
Device Description
The Benzodiazepine Calibrator Set contains 5 levels of calibrator containing the specific drug Oxazepam. The Calibrators are spiked at 4 different levels which assess below, at and above the cutoff of 200 ng/ml.
The Benzodiazepine Controls are manufactured at two levels, one below the cutoff and one above the cutoff of 200 ng/ml.
The base matrix used for the manufacture of Randox Benzodiazepine Calibrators and Controls is Drug Free Human Urine.
The Benzodiazepine Calibrators and Controls contain the specific drug Oxazepam. The Oxazepam is supplied by Cerilliant Corporation the accuracy of which is ensured by purity determinations (GC/FID, HPLC and NMR) and gravimetric preparation using balances calibrated with NIST traceable weights.
Randox Benzodiazepine Calibrators and Controls have been designed for in vitro diagnostic use only. They should not be pipetted by mouth and the normal precautions for handling laboratory reagents should be applied. Randox Benzodiazepine Calibrators and Controls contain sodium azide at 0.05%.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription use only.
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)
Open vial stability of the Benzodiazepine Calibrators and Controls level 1 and 2 were assessed by opening a set of calibrators and controls, replacing the caps and storing at +2℃ to +8℃ for 28 days. At day 7, 21 and 28 an aliquot was removed for assessment. The recovery of each calibrator and control was compared to a freshly opened set of calibrators and controls at day 7, 21 and 28. The acceptance criteria was the percentage deviation of the fresh vial compared to the open vial at each time point should be less than or equal to 10%. The data demonstrates that the Benzodiazeoine Calibrators and Controls for three batches are stable for 28 days when opened, recapped and stored at +2°C to +8ºC.
Shelf life for Benzodiazepine Calibrators was assessed by real time stability studies and accelerated stability studies. Once a new batch of calibrators are manufactured, 5 calibrator sets are set aside and stored at +2℃ to +8℃. After 1. 3, 6, 9 and 12 months as set of calibrators are assessed and compared to day 0 calibrators. The acceptance criteria states the calibration absorbance achieved at each time point should be 100% ±10% when compared to the fresh assessment. The data demonstrates that the Benzodiazepine calibrators were stable for 12 months at +2℃ to +8℃ when stored unopened.
Accelerated stability studies were used to predict the shelf life of the Benzodiazepine calibrator set. Six sets of Benzodiazepine calibrators were stored at +37°C for 1, 3, 5, 7, 10 and 12 days. At each time point the calibration absorbance's achieved are compared to those achieved at Day 0. Storage at +37℃ for 5 days is equivalent to 12 months shelf life. The data demonstrates that the Benzodiazepine calibrators are stable for at least 12 months at +2ºC to +8ºC when stored unopened.
Following Real time stability testing for Benzodiazepine Controls, 5 sets are set aside and stored at +2°C to +8℃. At 3. 4. 6. 9 and 12 months a set of controls are assessed. The acceptance criteria for Benzodiazepine control 1 states the concentration should be less than the cutoff of 200 ng/ml and for Benzodiazepine control 2 the concentration should be greater than the cutoff of 200ng/ml. The data demonstrates that the Benzodiazepine Controls are stable for at least 12 months at +2ºC to +8ºC when stored unopened.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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).
Not Found
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
1. SAFETY AND EFFECTIVENESS AS REQUIRED BY 21 CFR 807.92 STATEMENT
AUG 8 2013
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 Clodagh Finnegan clodagh.finnegan@randox.com 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: Randox Benzodiazepine Calibrator Set and Randox Benzodiazepine Controls Level 1 and 2
Common Name:
Benzodiazepine Calibrators Set (Levels 0, 1, 2, 3 and 4) Benzodiazepine Controls Levels 1 and 2
Purpose for Submission: New Device
Regulatory Classification:
Calibrators Drug Specific Clinical Toxicology Control Material
Panel: Toxicology
Product Code: DLJ & LAS
21 CFR Number: 21 CFR 862.3200 & 21CFR 862.3280
1
4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS
Predicate Device Proprietary Name:
Lin-Zhi International, Inc, LZI Multiple Analyte Urine Drugs of Abuse Calibrators and Controls
510 (k) Number: K051088
5. INTENDED USE
Randox Benzodiazepine Calibrator Set
The Randox Benzodiazepine Calibrator set consists of liquid calibrators containing Oxazepam. There are 5 levels of calibrator. They have been developed for use in the calibration of the RX series analysers in human urine, which includes the RX Davtona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.
Randox Benzodiazepine Controls Level 1 & 2
The Randox Benzodiazepine Controls are liguid controls containing Oxazepam. There are 2 levels of controls. They have been developed for use in the quality control and validation of Benzodiazepine assay on the RX series analysers in human urine, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.
6. DEVICE DESCRIPTION
The Benzodiazepine Calibrator Set contains 5 levels of calibrator containing the specific drug Oxazepam. The Calibrators are spiked at 4 different levels which assess below, at and above the cutoff of 200 ng/ml.
The Benzodiazepine Controls are manufactured at two levels, one below the cutoff and one above the cutoff of 200 ng/ml.
The base matrix used for the manufacture of Randox Benzodiazepine Calibrators and Controls is Drug Free Human Urine.
The Benzodiazepine Calibrators and Controls contain the specific drug Oxazepam. The Oxazepam is supplied by Cerilliant Corporation the accuracy of which is ensured by purity determinations (GC/FID, HPLC and NMR) and gravimetric preparation using balances calibrated with NIST traceable weights.
Randox Benzodiazepine Calibrators and Controls have been designed for in vitro diagnostic use only. They should not be pipetted by mouth and the normal precautions for handling laboratory reagents should be applied. Randox Benzodiazepine Calibrators and Controls contain sodium azide at 0.05%.
2
7. PREDICATE DEVICE COMPARISON TABLE
Oxazepam
DRUGS
| Similarities | ||
|---|---|---|
| CHARACTERISTICS | RANDOX BENZODIAZEPINE | |
| CALIBRATORS AND CONTROLS | LIN-ZHI DRUG MIXTURE | |
| CALIBRATOR AND | ||
| CONTROLS K051088 | ||
| FORMAT | Liquid calibrators and controls | Same |
| MATRIX | Urine matrix for calibrators and controls | Same |
| Differences | ||
| CHARACTERISTICS | RANDOX BENZODIAZEPINE | |
| CALIBRATORS AND CONTROLS | LIN-ZHI DRUG MIXTURE | |
| CALIBRATOR AND | ||
| CONTROLS K051088 | ||
| INTENDED USE | The Randox Benzodiazepine Calibrator set | |
| consists of liquid calibrators containing Oxazepam. | ||
| There are 5 levels of calibrator. They have been | ||
| developed for use in the calibration of the RX series | ||
| analysers in human urine, which includes the RX | ||
| Daytona and the RX Imola. This in vitro diagnostic | ||
| device is intended for prescription use only. |
The Randox Benzodiazepine Controls are liquid
controls containing Oxazepam. There are 2 levels of
controls. They have been developed for use in the
quality control and validation of Benzodiazepine
assay on the RX series analysers in human urine,
which includes the RX Daytona and the RX Imola.
This in vitro diagnostic device is intended for
prescription use only. | Intended for in vitro diagnostic
use for the calibration and
validation of LZI DAU enzyme
immunoassays to detect
methamphetamine, opiate,
phencyclidine, benzoylecgonine,
barbiturates, methadone, and
propoxyphene in human urine |
| LEVELS | Calibrators: there are a total of 5 levels, including
negative
Controls: there are two levels | Total of 7 levels, including
negative |
| STORAGE
(Unopened) | Calibrators and Controls: when not in use bottles
should be capped at all times and refrigerated at
2-8°C until expiration date. | Calibrators and Controls when
not in use bottles should be
capped at all times and
refrigerated at 2-8°C. |
| OPEN VIAL CLAIM | Calibrators and Controls are stable for 28 days
after opening capped and stored at 2-8°C | Unknown |
| | Calibrators and Controls:
Benzodiazepine | Multianalyte
Methamphetamine, Opiate |
Phencyclidine, Benzolecgonine Benzodiazepines, Barbiturates Methadone, Propoxyphene
3
8. SUMMARY OF STABILITY STUDIES
Open vial stability of the Benzodiazepine Calibrators and Controls level 1 and 2 were assessed by opening a set of calibrators and controls, replacing the caps and storing at +2℃ to +8℃ for 28 days. At day 7, 21 and 28 an aliquot was removed for assessment. The recovery of each calibrator and control was compared to a freshly opened set of calibrators and controls at day 7, 21 and 28. The acceptance criteria was the percentage deviation of the fresh vial compared to the open vial at each time point should be less than or equal to 10%. Table 1 below shows a summary of the open vial stability for Benzodiazepine calibrators and controls. The instrument used for this assessment was the Randox Imola (K052914). The assay used was the Benzodiazepine Assay (K092274).
| Table 1 | ||||
|---|---|---|---|---|
| Batch Lot | Material | Time point | ||
| Day 7 | Day 21 | Day 28 | ||
| 242516 | Calibrators 1-4 | Pass | Pass | Pass |
| 51110 | Calibrators 1-4 | Pass | Pass | Pass |
| 61110 | Calibrators 1-4 | Pass | Pass | Pass |
| 250-251DA | Controls 1-2 | Pass | Pass | Pass |
| 51110 | Controls 1-2 | Pass | Pass | Pass |
| 61110 | Controls 1-2 | Pass | Pass | Pass |
The data demonstrates that the Benzodiazeoine Calibrators and Controls for three batches are stable for 28 days when opened, recapped and stored at +2°C to +8ºC.
Shelf life for Benzodiazepine Calibrators was assessed by real time stability studies and accelerated stability studies. Once a new batch of calibrators are manufactured, 5 calibrator sets are set aside and stored at +2℃ to +8℃. After 1. 3, 6, 9 and 12 months as set of calibrators are assessed and compared to day 0 calibrators. The acceptance criteria states the calibration absorbance achieved at each time point should be 100% ±10% when compared to the fresh assessment. The instrument used for this assessment was the Randox Imola (K052914). The assay used was the Benzodiazepine Assay (K092274).
| 1 | able | C |
|---|---|---|
| Batch Lot | Material | Time point in months | ||||
|---|---|---|---|---|---|---|
| 1 | 3 | 6 | 9 | 12 | ||
| 023- | ||||||
| 027DA | Calibrators | |||||
| 1-4 | Pass | Pass | Pass | Pass | Pass |
The data demonstrates in table 2 that the Benzodiazepine calibrators were stable for 12 months at +2℃ to +8℃ when stored unopened.
4
Accelerated stability studies were used to predict the shelf life of the Benzodiazepine calibrator set. Six sets of Benzodiazepine calibrators were stored at +37°C for 1, 3, 5, 7, 10 and 12 days. At each time point the calibration absorbance's achieved are compared to those achieved at Day 0. Storage at +37℃ for 5 days is equivalent to 12 months shelf life.
Table 3
| Batch Lot | Material | Time point in Days | |||||
|---|---|---|---|---|---|---|---|
| 1 | 3 | 5 | 7 | 10 | 12 | ||
| 023-027DA | Calibrators 1-4 | Pass | Pass | Pass | Pass | Pass | Pass |
The data demonstrates in table 3 that the Benzodiazepine calibrators are stable for at least 12 months at +2ºC to +8ºC when stored unopened.
time stability testing for Benzodiazepine Controls. Following Real the manufacture of Benzodiazepine controls 5 sets are set aside and stored at +2°C to +8℃. At 3. 4. 6. 9 and 12 months a set of controls are assessed. The acceptance criteria for Benzodiazepine control 1 states the concentration should be less than the cutoff of 200 ng/ml and for Benzodiazepine control 2 the concentration should be greater than the cutoff of 200ng/ml.
| Batch Lot | Material | Time point in Months | ||||
|---|---|---|---|---|---|---|
| 3 | 4 | 6 | 9 | 12 | ||
| 482DA | Controls 1-2 | Pass | Pass | Pass | Pass | Pass |
| 483DA | Controls 1-2 | Pass | Pass | Pass | Pass | Pass |
The data demonstrates that the Benzodiazepine Controls are stable for at least 12 months at +2ºC to +8ºC when stored unopened.
9. SUMMARY OF VALUE ASSIGNMENT
A concentration is calculated for each new batch of Randox Benzodiazepine Calibrators and Controls by nest testing. Nest testing involves assessment of the new lot of controls against a master lot of controls or calibrators. Ten replicates of the test calibrators/controls are assessed and the mean and CV calculated. The recovery of the master lot is also measured. The acceptance criteria states the precision measured by the CV should be less than or equal to 15%. The recovery error of the master lot is also measured and should be ± 10% for all calibrator and control levels. The instrument used for this assessment was the Randox Imola (K052914). The assay used was the Benzodiazepine Assay (K092274).
5
Please see summary table below.
| Calibrator / Control Level | Lot # | Concentration of Oxazepam (ng/ml) |
|---|---|---|
| Calibrator Level 1 | 584DA | 100 |
| Calibrator Level 2 | 585DA | 200 |
| Calibrator Level 3 | 586DA | 300 |
| Calibrator Level 4 | 587DA | 1000 |
| Control Level 1 | 596DA | 150 |
| Control Level 2 | 597DA | 250 |
10. TRACEABILITY
The Benzodiazepine Calibrators and Controls are prepared using drug free human urine as the base material. Oxazepam is spiked into the calibrators and controls at various concentrations. The Oxazepam is supplied by Cerillant Corporation the accuracy of which is ensured by purity determinations (GC/FID, HPLC and NMR) and gravimetric preparation using balances calibrated with NIST traceable weights.
11. CONCLUSION
Testing results indicate that the proposed device is substantially equivalent to the predicate devices.
6
EPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains an image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle.
Public Health Service
Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G6 Silver Spring, MD 20993-0002
August 8, 2013
Randox Laboratories Limited C/O Dr. Pauline Armstrong 55 Diamond Road, Crumlin County Antrim, BT29 4QY UNITED KINGDOM
Re: K132090
Trade/Device Name: Randox Benzodiazepine Calibrator Set Randox Benzodiazepine Controls Level 1 and 2 Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: II Product Code: DLJ, LAS Dated: July 3, 2013 Received: July 15, 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, I isting 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 CER Port 807), labeline (21) Connements, including, but not limited to: 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 (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
7
Page 2-Dr. Armstrong
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please the Colliness. It a gov/AboutFDA/CentersOffices/CDRH/CDRHORTics://cm115809.html 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
l1110//WWW.Ida.gov/MedicalDevices/Safetv/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 tollit the 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 C. 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
8
Indications for Use
510(k) Number (if known): K132090
Device Name: Randox Benzodiazepine Calibrator Set Randox Benzodiazepine Controls Level 1 and 2
Indications for Use:
Randox Benzodiazepine Calibrator Set
The Randox Benzodiazepine Calibrator set consists of liquid calibrators containing Oxazepam. There are 5 levels of calibrator. They have been developed for use in the calibration of the RX series analysers in human urine, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.
Randox Benzodiazepine Controls Level 1 &2
The Randox Benzodiazepine Controls are liquid controls containing Oxazepam. There are 2 levels of controls. They have been developed for use in the quality control and validation of Benzodiazepine assay on the RX series analysers in humar winro, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.
Prescription Use X (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)
Denise Johnson-lyles -S 2013.08.08 07:32:10 -04'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K132090