Quanta Lite Ribosome P Elisa
FDA 510(k)FDA UDIClass II (US FDA 510(k))
Identity
- Trade Name
- QUANTA Lite® Ribosome P ELISA FDA UDI
- Generic Name
- Ribosomal phosphoprotein antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 1. 1x Ribosome P ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Ribosome P ELISA Low Positive 4. 1x 1.2mL prediluted Ribosome P ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
- Model / Reference
- 708600 FDA UDI
- Description
- 1. 1x Ribosome P ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Ribosome P ELISA Low Positive 4. 1x 1.2mL prediluted Ribosome P ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950506348 FDA UDI
- 510(k) Number
- FDA Product Code
- MQA FDA 510(k)FDA UDI
- GMDN Term
- Ribosomal phosphoprotein antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 866.5100 FDA 510(k)
- Regulation Number
- 866.5100 FDA 510(k)FDA UDI
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The Quanta Lite Ribosome P Elisa is an in vitro diagnostic test used to detect ribosome P antibodies in human serum, utilizing enzyme-linked immunosorbent assay (ELISA) technology. It is classified as an Anti-Ribosomal P Antibodies device. The device is used for semi-quantitative detection of autoantibodies in human serum. The Quanta Lite Ribosome P Elisa is a medical device in the field of Immunology. It is designed for anti-Ribosome P antibody detection, aiding in the diagnosis of diseases such as SLE.
The Quanta Lite Ribosome P Elisa is supplied by Inova Diagnostics, Inc. and has been cleared under the FDA 510(k) premarket notification, with the clearance number K981237. The device is classified as a class 2 device, with the regulation number 866.5100. The Quanta Lite Ribosome P Elisa is intended for use in a laboratory setting, with the device utilizing ELISA technology to detect ribosome P antibodies in human serum.
Frequently asked questions
What is the Quanta Lite Ribosome P ELISA used for?
The Quanta Lite Ribosome P ELISA is an in vitro diagnostic test designed to detect ribosome P antibodies in human serum. These antibodies are associated with autoimmune diseases, particularly systemic lupus erythematosus (SLE). By using enzyme-linked immunosorbent assay (ELISA) technology, the test provides a semi-quantitative measurement of autoantibody levels, helping clinicians diagnose or monitor conditions linked to anti-ribosome P antibodies.
How is the Quanta Lite Ribosome P ELISA supplied, and where is it used?
The Quanta Lite Ribosome P ELISA is supplied by Inova Diagnostics, Inc. and is intended exclusively for use in laboratory settings. The kit includes all necessary reagents and components for performing the ELISA test on human serum samples, ensuring accurate detection of ribosome P antibodies under controlled conditions.
Is the Quanta Lite Ribosome P ELISA single-use or reusable?
The Quanta Lite Ribosome P ELISA is designed for single-use per test run. Each kit is intended for a specific number of tests as outlined in the accompanying instructions, ensuring consistency and reliability in results. Reuse of components is not recommended, as it could compromise accuracy or sterility.
What regulatory clearance does the Quanta Lite Ribosome P ELISA hold?
The Quanta Lite Ribosome P ELISA has been cleared under the FDA’s 510(k) premarket notification process, with clearance number K981237. This classification confirms that the device is substantially equivalent to a legally marketed predicate device and meets regulatory standards for safety and effectiveness in detecting anti-ribosome P antibodies.
How should the Quanta Lite Ribosome P ELISA be stored?
Storage instructions for the Quanta Lite Ribosome P ELISA are detailed in the product documentation provided by Inova Diagnostics. Generally, ELISA kits require refrigeration (typically between 2°C and 8°C) to maintain stability and integrity of the reagents. Avoid freezing, exposure to direct sunlight, or contamination with moisture or chemicals. Always follow the manufacturer’s guidelines to preserve test accuracy.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: QUANTA LITE RIBOSOME P ELISA (K981237) — FDA 510(k) | Innolitics, QUANTA Lite | Werfen North America, QUANTA Lite (R) Ribosome P Reagents | Werfen North America, Quanta Lite Ribosome P Elisa 510 (k) FDA Premarket Notification K981237 ..., QUANTA LITE RIBOSOME P ELISA (K981237) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K981237 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (2)
- FDA 510(k) K981237 24 fields · synced Oct 1, 2026
- FDA UDI 6745947d-599e-400f-b89f-95164b99dcc8 36 fields · synced May 27, 2026