STC Barbiturates Intercept Micro-Plate EIA, Model 1108I
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K001976 FDA 510(k)
- FDA Product Code
- DIS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3150 FDA 510(k)
- Regulation Number
- 862.3150 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is an enzyme immunoassay (EIA) test system intended for the detection of barbiturates in clinical specimens such as serum, urine, and gastric contents. It is classified under regulation number 862.3150 and product code DIS, with a medical specialty designation in Clinical Toxicology.
The STC Barbiturates Intercept Micro-Plate EIA, Model 1108I received FDA 510(k) clearance (K001976) on December 6, 2000, and was found substantially equivalent to a predicate device. It is manufactured by OraSure Technologies, Inc., and is intended for use in laboratory settings for toxicology screening.
Frequently asked questions
What is the STC Barbiturates Intercept Micro-Plate EIA, Model 1108I used for?
This device is an enzyme immunoassay (EIA) test system intended for the detection of barbiturates in clinical specimens such as serum, urine, and gastric contents, as stated in the device description. It is designed for use in laboratory settings for toxicology screening, specifically within the medical specialty of Clinical Toxicology.
How is the STC Barbiturates Intercept Micro-Plate EIA, Model 1108I supplied or configured for use?
The device is supplied as a micro-plate based enzyme immunoassay (EIA) test system, Model 1108I, manufactured by OraSure Technologies, Inc. It is intended for laboratory use and requires appropriate instrumentation and reagents to perform the assay, though specific kit components are not detailed in the provided data.
Is the STC Barbiturates Intercept Micro-Plate EIA, Model 1108I intended for single-use or reusable applications?
As an enzyme immunoassay test system utilizing a micro-plate format, the STC Barbiturates Intercept Micro-Plate EIA, Model 1108I is designed for single-use testing runs. The micro-plates are typically discarded after use to prevent cross-contamination, which is standard practice for such immunoassay systems in clinical toxicology laboratories.
What regulatory pathway was used for the STC Barbiturates Intercept Micro-Plate EIA, Model 1108I?
The device received FDA 510(k) clearance under submission number K001976 on December 6, 2000, and was found substantially equivalent to a predicate device. This traditional 510(k) pathway is indicated by the clearance_type field and the decision_code SESE (Substantially Equivalent, Same Equipment).
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: Stc Barbiturates Intercept Micro-plate Eia, Model 1108i (K001976) — Fda ..., PDF K001976 Stc Barbiturates Intercept Micro-plate Eia, Model 1108i, STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K001976 | Class II | Active |
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Manufacturer
- Manufacturer
- OraSure Technologies, Inc.
Sources (1)
- FDA 510(k) K001976 24 fields · synced Sep 21, 2026