(27 days)
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No
The document describes a quality control material for laboratory testing and does not mention any AI or ML components.
No
The device is described as an "in vitro diagnostic device" and a "quality control material" for determining albumin in human urine. It is used for diagnosis and monitoring, not for treating or preventing disease.
No
Explanation: The document explicitly states that the Randox Microalbumin Liquid Controls are "designed for use as assayed quality control materials." Control materials are used to monitor the performance of a diagnostic test, not to diagnose a patient directly. While they are part of a diagnostic process, they are not the diagnostic device itself. The text also refers to it as an "in vitro diagnostic device," but in the context of its function as a control material, it supports diagnosis rather than performing it.
No
The device is a liquid control material for in vitro diagnostic testing, not a software-only medical device. It is a physical substance used for quality control.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states, "This in vitro diagnostic device is intended for prescription use only and can only be used by professionals." This is a clear declaration of its intended use as an IVD.
- Device Description: The description mentions it's used for the "quantitative determination of albumin in human urine," which is a laboratory test performed on a biological sample (urine) outside of the body to provide information about a person's health. This aligns with the definition of an in vitro diagnostic.
- Predicate Device: The mention of a predicate device (K072835; LIQUICHEK™ Microalbumin Control Levels 1 and 2) which is also a control material for microalbumin testing, further supports its classification as an IVD. Predicate devices are typically other legally marketed IVDs.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Summary of Value Assignment
Sample Size: 10 reps were run on the following analysers
Key Results:
Target values and acceptable manufacturing ranges were established:
- For MA041 (Level 1): Target Value 30 mg/L, Acceptable Manufacturing Range 20 - 40 mg/L, %CV ≤ 5, % RECOVERY ERROR ≤ 5
- For MA042 (Level 2): Target Value 150 mg/L, Acceptable Manufacturing Range 130 – 170 mg/L, %CV ≤ 5, % RECOVERY ERROR ≤ 5
Testing results indicate that the proposed device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- %CV
- % RECOVERY ERROR
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.
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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).
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§ 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.
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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 MICROALBUMIN
CONTROL LEVEL 1 AND
CONTROL LEVEL 2 | LIQUICHEK™ MICROALBUMIN
CONTROL LEVELS 1 AND 2
K072835 | |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| INTENDED USE | Randox Microalbumin Control Levels 1
and 2 are designed for in vitro diagnostic
use as assayed quality control materials
for the guantitative determination of
albumin in human urine. | Liquichek Microalbumin Control is
intended for use as assayed quality
control urine to monitor the precision of
laboratory testing procedures for the
analytes Microalbumin and Creatinine. | |
| SIZE | Microalbumin Liquid Controls
6x1mls | Level 1 12x10mls
Level 2 12x10mls
Bilevel Mini Pak 2x10mls | |
| FORMAT | Liquid | Liquid | |
| MATRIX | Prepared from Human Serum | · Prepared from Human Urine | |
| STORAGE
(Unopened) | The Microalbumin Liquid Controls are
supplied ready for use and are stable up
to the expiry date when capped and
stored at +2 to +8°C. | The Liquichek Microalbumin controls
are supplied ready for use and are
stable up to the expiry date when
capped and stored at +2 to +8°C. | |
| ANALYTES | Microalbumin | Microalbumin | |
| | | Creatinine | |
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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.
| PRODUCT
NUMBER(S) | TARGET VALUE | ACCEPTABLE
MANUFACTURING
RANGE | %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 | PRODUCT
NUMBER | 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