(31 days)
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No
The summary describes a quality control material for clinical chemistry analyzers and does not mention any AI or ML components or functionalities.
No.
The device is an in vitro diagnostic quality control material used for the quantitative determination of aldolase, not for treatment or diagnosis of a disease in a patient.
No
Explanation: This device is a quality control material intended for use in the quantitative determination of aldolase on clinical chemistry analyzers. It is used to ensure the accuracy of diagnostic tests, not to diagnose a condition itself.
No
The device is a quality control material for in vitro diagnostic use, supplied in lyophilized form and requiring reconstitution. It is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the controls are "intended for in vitro diagnostic use as assayed quality control materials for the quantitative determination of aldolase on the clinical chemistry analyzers indicated in the package insert." This directly aligns with the definition of an IVD, which are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description mentions the controls are prepared from human serum and are used with clinical chemistry analyzers, which are common tools in in vitro diagnostic testing.
- Prescription Use Only: The "Prescription use only" statement further indicates that this device is intended for use in a clinical setting under the direction of a healthcare professional, which is typical for IVDs.
- Performance Studies: The inclusion of stability studies and value assignment studies, including metrics like CV%, are standard practices for demonstrating the performance and reliability of IVD devices.
- Predicate Device: The mention of a predicate device (K000875; BIO-RAD OCS Assayed Control) which is also an IVD, strongly suggests that this device falls into the same category.
Therefore, based on the provided information, the Randox Aldolase Control Level 2 and Aldolase Control Level 3 are clearly intended and function as In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Randox Aldolase Control Level 2 and Aldolase Control Level 3 are intended for in vitro diagnostic use as assayed quality control materials for the quantitative determination of aldolase on the clinical chemistry analyzers indicated in the package insert. This device is for prescription use only.
Product codes
JJX
Device Description
Randox Aldolase Control is manufactured at two levels, Level 3. Each control is prepared from human serum with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilized form in 3x1 mL vials and require reconstitution with 1 mL of distilled water.
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
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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
The reconstituted stability of Aldolase was determined by reconstituting vials of Aldolase Controls and storing them at +20C to +80C for 5 days.
Unopened: Store refrigerated (+2℃ to +8℃). Stable to the expiration date printed on individual vials. The Aldolase Controls have been assigned a shelf life of 24 months. This has been tested using real time studies, three batches of the Aldolase controls have been stored at +2℃ to +8℃ for a period of at least 24 months and all three batches have passed real time stability testing.
An assigned value is calculated for each new batch of Randox Aldolase 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 controls are assessed on two or more systems and the mean and CV calculated. The recovery of the master lot is also measured. In the instructions for use there are system specific values quoted and a consensus mean. A range is also provided by taking +/- 25% of the assigned system specific values and the consensus mean. The acceptance criteria states the precision measured by the CV should be less than or equal to 3%, unless the concentration of aldolase in
§ 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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510(k) Summary
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
JUL 1 8 2013
Name: Dr. Clodagh Finnegan clodagh.finnegan@randox.com
Address: Randox Laboratories Limited 55 Diamond Road, Crumlin County Antrim BT294OY. United Kingdom
Telephone: +44(0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 E-mail: marketing@randox.com
3. 510(k) NUMBER, DEVICE PROPRIETARY NAME, COMMON NAME, PURPOSE FOR SUBMISSION, REGULATORY CLASSIFICATION, PANEL, PRODUCT CODE AND 21 CFR NUMBER
510k Number: K131776
Device Proprietary Name: Adolase Control Level 2 and Adolase Control Level 3
ﺮ ﺩ
Common Name: Aldolase Controls
Purpose for Submission: New Device
Regulatory Classification: Single Specified Analyte Controls, (assayed and unassayed); Class I, reserved
Panel: Clinical Chemistry
Product Code: JJX
21 CFR Number: 21 CFR 862.1660
4. PREDICATE DEVICE PROPRIETARY NAME AND 510(k) NUMBER
BIO-RAD OCS Assayed Control 510(k) Number: K000875
5. INTENDED USE
The Randox Aldolase Control Level 2 and Aldolase Control Level 3 are intended for in vitro diagnostic use as assayed quality control materials for the quantitative determination of aldolase on the clinical chemistry analyzers indicated in the package insert. This device is for prescription use only.
6. DEVICE DISCRIPTION
Randox Aldolase Control is manufactured at two levels, Level 3. Each control is prepared from human serum with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilized form in 3x1 mL vials and require reconstitution with 1 mL of distilled water.
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7. PREDICATE DEVICE COMPARISON TABLE
Comparison of Randox Aldolase Controls Level 2 and 3 with the Predicate Device
| Similarities and Differences | ||
|---|---|---|
| CHARACTERISTICS | RANDOX ALDOLASE CONTROLS LEVEL 2 AND 3 | |
| (New Device) | BIO-RAD | |
| QCS Assayed Control (K000875) | ||
| (Predicate Device) | ||
| INTENDED USE | The Randox Aldolase Control Level 2 and | |
| Aldolase Control Level 3 are intended for in | ||
| vitro diagnostic use as assayed quality control | ||
| materials for the quantitative determination | ||
| of aldolase on the clinical chemistry analyzers | ||
| indicated in the package insert. This device is | ||
| for prescription use only. | An assayed quality control serum to monitor | |
| the precision of laboratory testing procedures | ||
| for the numerous analytes listed in the | ||
| package insert | ||
| FORMAT | Lyophilised | Lyophilised |
| MATRIX | Human Serum | Human Serum |
| STORAGE | ||
| (Unopened) | 2 to 8 °C | |
| Until expiration date | 2 to 8 °C | |
| Until expiration date | ||
| OPEN VIAL CLAIM | 5 days when stored at 2 to 8 °C after | |
| reconstitution | Analyze Aldolase as soon as possible after | |
| reconstitution due to rapid decrease in activity | ||
| with time | ||
| SIZE | 1ml | 5ml |
| Shelf life | 24 months when stored at 2 to 8°C | 48 months when stored at 2 to 8°C |
8. SUMMARY OF STABILTY STUDIES
Opened: Store refrigerated (+2℃ to +8℃), Reconstituted Aldolase is stable for 5 days at +2℃ to +8℃
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if kept capped in the original container and free from contamination. Only the required amount of product should be removed. After use, any residual product should not be returned to the original vial.
The reconstituted stability of Aldolase was determined by reconstituting vials of Aldolase Controls and storing them at +20C to +80C for 5 days.
Unopened: Store refrigerated (+2℃ to +8℃). Stable to the expiration date printed on individual vials. The Aldolase Controls have been assigned a shelf life of 24 months. This has been tested using real time studies, three batches of the Aldolase controls have been stored at +2℃ to +8℃ for a period of at least 24 months and all three batches have passed real time stability testing.
9. SUMMARY OF VALUE ASSIGNMENT
An assigned value is calculated for each new batch of Randox Aldolase 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 controls are assessed on two or more systems and the mean and CV calculated. The recovery of the master lot is also measured. In the instructions for use there are system specific values quoted and a consensus mean. A range is also provided by taking +/- 25% of the assigned system specific values and the consensus mean. The acceptance criteria states the precision measured by the CV should be less than or equal to 3%, unless the concentration of aldolase in Prescription Use 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)
Ruth A. Chesler -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K131776 510(k)_