(27 days)
The Randox Microalbumin Liquid Controls are designed for use as assayed quality control materials for the quantitative determination of albumin in human urine. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.
Randox Microalbumin Controls are manufactured at two levels, Level 1 and Level 2. They are single analyte controls made with human serum. The analyte concentrations in each control have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.
Acceptance Criteria and Device Performance Study for Randox Microalbumin Control Level 1 and Level 2 (Liquid)
1. Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Level 1 (MA041) | ||
| Target Value | 30 mg/L | 30 mg/L (based on average of various analyzers) |
| Manufacturing Range | 20 - 40 mg/L | 20 - 40 mg/L |
| %CV | ≤ 5 | Not explicitly stated, but implies ≤ 5 as passing |
| % Recovery Error | ≤ 5 | Not explicitly stated, but implies ≤ 5 as passing |
| Level 2 (MA042) | ||
| Target Value | 150 mg/L | 150 mg/L (based on average of various analyzers) |
| Manufacturing Range | 130 – 170 mg/L | 130 – 170 mg/L |
| %CV | ≤ 5 | Not explicitly stated, but implies ≤ 5 as passing |
| % Recovery Error | ≤ 5 | Not explicitly stated, but implies ≤ 5 as passing |
Note: The reported device performance for %CV and % Recovery Error is inferred from the statement "The CV% and % recovery error result should fall within the range shown below," indicating that the study results met these criteria. Specific numerical values for the reported performance were not provided in the document beyond meeting the acceptable range.
2. Sample Size and Data Provenance for Test Set
- Sample Size: 10 replicates were run for each control level (Level 1 and Level 2) on each of the following analyzers: Hitachi 717, Cobas Mira, RX Daytona, and Dimension.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It implies prospective testing conducted by Randox Laboratories.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
The document states: "The analyte concentrations in each control have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories."
- Number of Experts: A "panel of experts" (specific number not given).
- Qualifications of Experts: Not explicitly stated, but their role suggests expertise in clinical chemistry, laboratory medicine, or related fields relevant to albumin measurement in urine and quality control.
4. Adjudication Method for Test Set
The adjudication method is not explicitly stated. The "Target Value" for each control level was assigned based on "the average of all the results from the various analysers," and a range of +/- 20% was then applied to this average to define the "Acceptable Manufacturing Range." This suggests a statistical averaging approach rather than a specific expert adjudication method like 2+1 or 3+1 for individual results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a quality control material, not an AI-powered diagnostic device, so a study comparing human readers with and without AI assistance is not applicable.
6. Standalone Performance Study
Yes, a standalone study was performed. The "Summary of Value Assignment" describes the testing of the control material on various analyzers (Hitachi 717, Cobas Mira, RX Daytona, and Dimension) to determine a target value and confirm the acceptable manufacturing range, %CV, and % Recovery Error. This represents the performance of the control material itself, without human interpretation as part of the primary outcome.
7. Type of Ground Truth Used (Test Set)
The ground truth used for the test set (value assignment) appears to be derived from the average of quantitative measurements obtained from multiple established laboratory analyzers. This effectively serves as a consensus-based quantitative ground truth established through instrument performance on the control samples. Additionally, a "panel of experts" reviewed the assigned concentrations for clinical relevance.
8. Sample Size for Training Set
The document does not describe a distinct training set in the context of an algorithm or AI model development. This device is a chemical control material, not an AI diagnostic algorithm. Therefore, "training set" as understood in AI/ML is not applicable here. The "value assignment" phase is more akin to a calibration or characterization study.
9. How Ground Truth for Training Set Was Established
As noted above, there is no distinct "training set" in the context of AI. For the value assignment (which can be considered analogous to establishing the 'correct' values for the control material), the ground truth was established by:
- Running 10 replicates of the control material on four different widely-used laboratory analyzers (Hitachi 717, Cobas Mira, RX Daytona, and Dimension).
- Calculating the average of all results from these various analyzers to assign the "Target Value."
- Reviewing these concentrations by a "panel of experts" to ensure clinical relevance.
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1. SAFETY AND EFFECTIVENESS AS REQUIRED BY 21 CFR 807.92
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirement 21 CFR 807.92.
JUL 1 1 2012
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. DEVICE PROPRIETARY NAME, COMMON NAME, PRODUCT CODE CLASSIFICATION AND 21 CFR NUMBER
Device Proprietary Name: Randox Microalbumin Control Level 1 and Level 2 (Liquid)
Common Names: Microalbumin Control Level 1 and Level 2
Product Code: JJX
Classification: Single (Specified) Analyte Controls (Assayed and Unassayed) Class I. reserved
21 CFR Number: 21 CRF 862.1660
4. PREDICATE DEVICE PROPRIETARY NAME AND 510 (k) NUMBER
Predicate Device Proprietary Name: LIQUICHEK™ Microalbumin Control Levels 1 and 2
510 (k) Number: K072835
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5. INTENDED USE
The Randox Microalbumin controls are designed for in vitro diagnostic use as assayed quality control materials for the quantitative determination of albumin in human urine.
6. DEVICE DESCRIPTION
Randox Microalbumin Controls are manufactured at two levels, Level 1 and Level They are single analyte controls made with human serum. The analyte 2. concentrations in each control have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.
PREDICATE DEVICE COMPARISON TABLE 7.
| CHARACTERISTICS | RANDOX MICROALBUMINCONTROL LEVEL 1 ANDCONTROL LEVEL 2 | LIQUICHEK™ MICROALBUMINCONTROL LEVELS 1 AND 2K072835 | |
|---|---|---|---|
| INTENDED USE | Randox Microalbumin Control Levels 1and 2 are designed for in vitro diagnosticuse as assayed quality control materialsfor the guantitative determination ofalbumin in human urine. | Liquichek Microalbumin Control isintended for use as assayed qualitycontrol urine to monitor the precision oflaboratory testing procedures for theanalytes Microalbumin and Creatinine. | |
| SIZE | Microalbumin Liquid Controls6x1mls | Level 1 12x10mlsLevel 2 12x10mlsBilevel Mini Pak 2x10mls | |
| FORMAT | Liquid | Liquid | |
| MATRIX | Prepared from Human Serum | · Prepared from Human Urine | |
| STORAGE(Unopened) | The Microalbumin Liquid Controls aresupplied ready for use and are stable upto the expiry date when capped andstored at +2 to +8°C. | The Liquichek Microalbumin controlsare supplied ready for use and arestable up to the expiry date whencapped and stored at +2 to +8°C. | |
| ANALYTES | Microalbumin | Microalbumin | |
| Creatinine |
3
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8. SUMMARY OF STABILITY STUDIES
OPENED: Store refrigerated (+2°C to +8°C). Microalbumin is stable for 28days if kept capped in the original container and free from contamination. Only the required amount of product should be removed.
UNOPENED: Store refrigerated (2°C to +8°C). Stable to the expiration date printed on the individual vials.
9. SUMMARY OF VALUE ASSIGNMENT
10 reps were run on the following analysers, Hitachi 717, Cobas Mira, RX Daytona and Dimension. One lot of previous control material was assessed to validate the run. A target was assigned based on the average of all the results from the various analysers and a range of +/- 20% was applied.
The CV% and % recovery error result should fall within the range shown below.
| PRODUCTNUMBER(S) | TARGET VALUE | ACCEPTABLEMANUFACTURINGRANGE | %CV | % RECOVERY ERROR |
|---|---|---|---|---|
| MA041 (Level 1) | 30 mg/L | 20 - 40 mg/L | ≤ 5 | ≤ 5 |
| MA042 (Level 2) | 150 mg/L | 130 – 170 mg/L | ≤ 5 | ≤ 5 |
10. TRACEABILITY
| ANALYTE | SUPPLIER | PRODUCTNUMBER | ORIGIN | SOURCE |
|---|---|---|---|---|
| Microalbumin | Sigma | A-8763 | Human | Human Serum |
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/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.
10903 New Hampshire Avenue Silver Spring, MD 20993
Randox Laboratories c/o Pauline Armstrong 55 Diamond Rd. Crumlin, County Antrim United Kingdom BT29 4QY
JUL 1 1 2012
K121746 Re:
K121740
Trade Name: Randox Microalbumin Control Level 1 and Level 2 (Liquid) Regulation Number: 21 CFR §862.1660 Regulation Name: Single (Specified) Analyte Controls (Assayed) Regulatory Class: Class I, reserved Product Codes: JJX Dated: June 14, 2012 Received: June 14, 2012
Dear Ms. Armstrong:
We have reviewed your Section 510(k) premarket notification of intent to market the device We liave reviewed your Section 310(4) procession is substantially equivalent (for the referenced above and have determined the device to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate collinered prof to thay 20, 1978, and sized in accordance with the provisions of Amendments, of to Gevices that have book formsther do not require approval of a premarket the Federal Food, Drug, and Cosment . Fer (recre, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the Act. The gentiral of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (sec adove) into controls. Existing major regulations affecting (PMA), it may of Subject to Such additional Connects ------------------------------------------------------------------------------------------------------------------------your device can be found in Title 21, Code of Peacharter (1 - 1)
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 Please be advised that FDA S Issualice of a substantes with other requirements
mean that FDA has made a determination that your device Fodorol ageacies mean that FDA Illas made a decemination hatt 700atministered by other Federal agencies.
of the Act or any Federal statutes and regulations and mot limited to: registration of the Act of any rederal stants and roginatents, including, but not limited to: registration
You must comply with all the Act of a created and 800; medical device You must comply with an the Act Siequationship.
and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and oc and listing (21 CFR Fall 807), labeling (27 OF R-10 (21 CFR 803); and good
reporting (reporting of medical device-related adverse (QS) requation reporting (reporting of medical device-related daverse oversion (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you deen o openio an Noro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's CI K Fat 607.97). Por queetions rogas (08 p ) Division of Postmarket Surveillance at (301) 01160 of Bur remains and regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
OFF : art 009), preace aroblem/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 Tou may other baner gefarers, International and Consumer Assistance at its to!!-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Randox Microalbumin Control Level 1-and Control Level 2
Indication for Use:
The Randox Microalbumin Liquid Controls are designed for use as assayed quality control materials for the quantitative determination of albumin in human urine.
This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.
V Prescription Use _ (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 Diagnostic Devices (OIVD)
Division Sign-Off Division bign of In Vitro Diagnostic Device Evaluation and Safety
510(k) 1411746
§ 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.