(255 days)
No
The summary describes a reagent kit for a laboratory analyzer and focuses on standard analytical performance metrics. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic (IVD) kit used for the quantitative measurement of albumin to aid in the diagnosis of kidney and intestinal diseases. It does not provide any therapeutic intervention.
Yes
The device is described as "intended for the quantitative in vitro measurement of albumin in CSF, urine and serum... to aid in the diagnosis of kidney and intestinal diseases." This directly indicates its use in diagnosing medical conditions.
No
The device description explicitly states it is comprised of reagents (Antiserum, Calibrator and Controls, Reaction Buffer) and is used with an analyzer. This indicates it is a physical kit and not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The statement explicitly says "intended for the quantitative in vitro measurement of albumin in CSF, urine and serum... to aid in the diagnosis of kidney and intestinal diseases." The phrase "in vitro" is the key indicator that the test is performed outside of the living body, which is the definition of an in vitro diagnostic.
- Device Description: It describes reagents (Antiserum, Calibrator, Controls, Reaction Buffer) used to perform a test on biological samples (CSF, urine, serum). This is typical of IVD kits.
- Anatomical Site: It specifies the biological samples being tested (CSF, urine, and serum), which are collected from the body but tested in vitro.
- Intended User/Care Setting: It indicates the test is performed in a "Clinical Laboratory," which is where IVD tests are typically conducted.
- Summary of Performance Studies: The studies described (Precision, Linearity, Detection Limit, Analytical Specificity, Antigen Excess Effects, Method Comparison) are standard performance evaluations for IVD devices.
- Predicate Device(s): The listed predicate devices are also IVD reagents (Antiserum, Protein Standard, Protein Control).
All of these factors strongly indicate that the Optilite Low Level Albumin Kit is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Optilite Low Level Albumin Kit is intended for the quantitative in vitro measurement of albumin in CSF, urine and serum using the Binding Site Optilite analyser to aid in the diagnosis of kidney and intestinal diseases. This test should be used in conjunction with other laboratory and clinical findings.
Product codes
DCF
Device Description
The Optilite Low Level Albumin Kit is comprised of the following reagents:
Antiserum: Supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 1mM ethylenediamine-tetraacetic acid (EDTA) and 0.01% benzamidine..
Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide. 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material.
Reaction Buffer: Containing 0.099% sodium azide as a preservative.
Note - In Optilite kits, the antiserum reagent and reaction buffer are supplied in a single wedge with a chamber for each fluid. They are therefore labelled as a single component Optilite LLAlb Reagent. The Antigen Excess Control does not have an assigned value.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
- Analytical performance:
- Precision/Reproducibility: Studies based on CLSI EP5-A2. 5 sample preparations for each matrix were tested in 2 runs per day (each of the 2 runs in duplicate) over 21 days using 3 analysers. Results met acceptance criteria for total precision (%CV
§ 866.5040 Albumin immunological test system.
(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(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 § 866.9.
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Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure, possibly suggesting care and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2016
The Binding Site Ltd. Mr. Jon Lauder Regulatory Affairs Officer 8 Calthorpe Road, Edgbaston, Birmingham, West Midlands, B15 1QT UK
Re: K153560
Trade/Device Name: Optilite® Low Level Albumin Kit Regulation Number: 21 CFR 866.5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Code: DCF Dated: July 22, 2016 Received: July 26, 2016
Dear Mr. Lauder:
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 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 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 (reporting of
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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/Resourcesfor You/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/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 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/Industry/default.htm.
Sincerely.
Kelly Oli ier -S
For
Leonthena Carrington, MBA, MS, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Optilite Low Level Albumin Kit
Indications for Use (Describe)
The Optilite Low Level Albumin Kit is intended for the quantitative in vitro measurement of albumin in CSF, urine and serum using the Binding Site Optilite analyser to aid in the diagnosis of kidney and intestinal diseases. This test should be used in conjunction with other laboratory and clinical findings.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Optilite Low Level Albumin Kit
510(k) SUMMARY
A. 510(k) Number:
B. Purpose for Submission:
New device
C. Measurand:
Albumin
D. Type of Test:
Quantitative immunoturbidimetry
E. Applicant:
The Binding Site
F. Proprietary and Established Names:
Optilite® Low Level Albumin Kit
G. Regulatory Information:
-
- Regulation section:
21 CFR 866.5040, Albumin immunological test system
- Regulation section:
-
- Classification:
Class II
- Classification:
-
- Product code:
DCF - Albumin antigen, antiserum, control
- Product code:
-
- Panel:
lmmunology (82)
- Panel:
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H. Intended use:
1. Intended use(s):
The Optilite Low Level Albumin Kit is intended for the quantitative in vitro measurement of albumin in CSF, urine and serum using the Binding Site Optilite analyser to aid in the diagnosis of kidney and intestinal diseases. This test should be used in conjunction with other laboratory and clinical findings.
2. Indication(s) for use:
Same as Intended use.
3. Special conditions for use statement(s):
Prescription use only
-
- Special instrument requirements:
Optilite Analyser (Indiko) (K110035)
- Special instrument requirements:
l. Device Description:
The Optilite Low Level Albumin Kit is comprised of the following reagents:
Antiserum: Supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 1mM ethylenediamine-tetraacetic acid (EDTA) and 0.01% benzamidine..
Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide. 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material.
Reaction Buffer: Containing 0.099% sodium azide as a preservative.
Note - In Optilite kits, the antiserum reagent and reaction buffer are supplied in a single wedge with a chamber for each fluid. They are therefore labelled as a single component Optilite LLAlb Reagent. The Antigen Excess Control does not have an assigned value.
J. Substantial equivalence information:
1. Predicate device name(s) and 510(k) number(s):
N Antiserum to Human Albumin K972929 N Protein Standard SL K964062 NT Protein Control SL K964065
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2. Comparison with predicate:
| Similarities | ||
|---|---|---|
| Item | Test device | Predicate |
| Assay type | Quantitative | same |
| Adult | ||
| Reference | ||
| Interval | Serum: 35000 - 52000mg/L | |
| Urine: |