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510(k) Data Aggregation
K Number
K964015Device Name
INDICARD TEST
Manufacturer
LITMUS CONCEPTS, INC.
Date Cleared
1997-06-19
(255 days)
Product Code
MJM
Regulation Number
866.2660Why did this record match?
Applicant Name (Manufacturer) :
LITMUS CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Indicard™ test is an enzyme activity test for use in the detection of Gardnerella vaginalis Proline IminoPeptidase (PIP) activity in vaginal fluid specimens from patients suspected of having vaginosis.
The Indicard™ test is indicated for professional use only and may be used at point of care. It is not intended for home use.
Device Description
The Indicard™ test is an enzyme activity test.
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K Number
K962718Device Name
FEMEXAM TESTCARD
Manufacturer
LITMUS CONCEPTS, INC.
Date Cleared
1997-02-07
(210 days)
Product Code
CEN
Regulation Number
862.1550Why did this record match?
Applicant Name (Manufacturer) :
LITMUS CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FemExam® TestCard™ contains two qualitative, colorimetric tests for use in the characterization of a vaginal fluid sample: (1) a pH test that differentiates vaginal fluid pH less than pH 4.7 from vaginal fluid pH equal to or greater than pH 4.7; and (2) a test that detects alkali volatilizable amines in vaginal fluid.
Device Description
The FemExam® TestCard™ contains two qualitative, colorimetric tests: a pH test and an amine test. The pH test uses nitrazine yellow to produce a visual color change within two minutes of specimen application, indicating pH less than or greater than 4.7. It includes a positive procedural control and a negative background control. The amine test uses bromocresol green (BCG) and sodium aluminate to produce a visual color change within two minutes of specimen application, indicating the presence of alkali volatilizable amines. It also includes a positive procedural control and a negative background control.
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