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510(k) Data Aggregation
K Number
K022538Device Name
IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
Manufacturer
DIAGNOSTIC CHEMICALS, LTD. (USA)
Date Cleared
2002-08-23
(22 days)
Product Code
JIR
Regulation Number
862.1645Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOSTIC CHEMICALS, LTD. (USA)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For IN VITRO diagnostic use.
There are several kidney disease conditions that can produce high levels of albumin in urine (1). Determining albumin in the urine at the low levels measured by this test is helpful for early detection and treatment of patients at risk for renal (kidney) disease. Low but elevated urinary albumin levels, or microalbuminuria, refers to a level of the human protein albumin in urine above about 18 mg/L. Levels above 18 mg/L are not normally found in healthy individuals. These low but significant levels are not detectable with older dipstick assays. The ImmunoDip™ Urinary Albumin Test classifies samples as positive based on their being above or below a level of 18 mg/L.
Conditions in which elevated levels of albumin in urine may be present include: Type 1 and Type 2 diabetes (2-8); hypertension (9, 10); and renal disease found in pregnancy (11). There are other less common causes as well. Diabetes is the largest single cause. One study found 45% of the insulin-dependent diabetics develop serious kidney disease (3). Testing for elevated levels of albumin in urine helps to identify those diabetics who are prone to kidney disease. Scientific studies indicate that proper control of blood glucose (blood sugar) levels and blood pressure help slow or prevent kidney damage (1, 9).
Device Description
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K Number
K974874Device Name
BILIRUBIN-SL (TOTAL) ASSAY
Manufacturer
DIAGNOSTIC CHEMICALS, LTD. (USA)
Date Cleared
1998-02-12
(45 days)
Product Code
CIG
Regulation Number
862.1110Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOSTIC CHEMICALS, LTD. (USA)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the quantitative determination of Total Bilirubin in serum. For IN VITRO diagnostic use.
Device Description
Traditional methods of measuring bilirubin are based on the reaction of bilirubin with a diazo reagent to form the colored compound: azo-bilirubin. The diazo reaction can be accelerated by the addition of various chemicals. For example, Malloy-Evelyn (1) used ethanol, Jendrassik-Grof (2) used caffeine, and Walters-Gerarde (3) used DMSO. Modifications of these methods included the addition of surfactants as solubilizing agents (4). In this method, a 2,4-dichlorophenyl diazonium salt is used as the diazo reagent and the reaction is facilitated by the use of a surfactant.
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