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510(k) Data Aggregation
K Number
K991156Device Name
GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM
Manufacturer
GREAT SMOKIES DIAGNOSTIC LABORATORY
Date Cleared
1999-05-28
(51 days)
Product Code
JOC
Regulation Number
862.1820Why did this record match?
Product Code :
JOC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Great Smokies lactulose/mannitol test for intestinal permeability is intended to measure the ratio of lactulose to mannitol in urine; the measurement is used in the diagnosis of gastrointestinal malabsorption syndrome.
Device Description
The device is a kit consisting of exempt components and accessories (urine specimen transport tubes (one white-capped "before drink" specimen tube and one purple-capped "after drink" specimen tube), a pipette, a small urine collection cup, a large urine collection container, a biohazard bag with absorbent pad, and a drink accessory (5g lactulose, 1g mannitol, 10g glycerine, and 3.84 ml water)). The drink is ingested after an overnight fast, and voided urine is then collected over a period of 6 hours to measure the level of lactulose and level of mannitol in urine and to obtain a ratio; the result is expressed as the percent recovery of an ingested dose of lactulose divided by the percent recovery of an ingested dose of mannitol. The measurement is used in the diagnosis of gastrointestinal malabsorption syndrome (a group of disorders in which there is abnormal absorption of dietary constituents, e.g., excessive absorption of substances or excessive loss from the body of nonabsorbed substances).
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