Page 2 of 5 A test line of color intensity greater than or equal to the comparator line indicates diminished ovarian reserve I Substa ntial Equivalence Information 1 Predicate d e vice names ID: 955351
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Page 2 of 5 observing for the formation of colored lines after 30 minutes. A test line of color intensity greater than or equal to the comparator line indicates diminished ovarian reserve. I. Substa ntial Equivalence Information: 1. Predicate d e vice name(s) : Abbott AxSYM FSH 2. Predicate K number(s): K935612 3. Comparison with predicate: Similarities Item Device Predicate Intended Use Test Principle Measurement of FSH Two - site immunometric assay Measurement of FSH Two - site immunometric assay D ifferences Item Device Predicate Intended Use Type of Test Sample Label (Detection) Support for Capture Antibody Interpolation of Result Detection Limit Over - the - counter use Qualitative Urine Colloidal gold Nitrocellulose strip Visually comp are test line to the reference line 10 IU/L Clinical laboratory use Quantitative Serum or p
lasma Alkaline phosphatase Microparticles Automated data reduction comparing test signal with stored calibration data 0.37 IU/L J. Standard/Guidance Documen t R eferenced (if applicable): None Referenced K. Test Principle: The test is a lateral flow immunochromatographic assay . FSH in the urine reacts with the conjugated and immobilized antibodies, forming a sandwich. L. Performance Charact eristics (if/when applicab le): 1. Analytical p erformance: a. Precision/Reproducibility : Seven control pools in the range of 2.9 ± , 8 / ) 6 + , 6 \f Z H U H P H D V X U H G R Q V H S D U D W H G D \ V E \ W K H V D P H R S H U D W R U X V L Q J W K H V D P H E D W F K R I G H Y L F H V 7 H V W U H S U R G X F L E L O L W \ Z D V \b E D V H G R Q Page 4 of 5 Potentially in terfering bacteria (repre
senting a gross level of bacterial infection) were spiked into five urine specimens containing FSH at concentrations below the test cut - off and five specimens above the cut - off. No interference was observed for the Gram negative or Gram positive bacteria. pH was evaluated for interference by testing five urine specimens containing FSH at concentrations below the test cut - off and five specimens above the cut - off with and without adjustments made to the pH. No interference was observ ed over the pH range of 5.2 ± f. Assay cut - off: See Detection limit above. 2. Comparison studies: a. Method comparison with predicate device : The objective of this study was to demonstrate equivalence between results from the two test methods. Specimens from various times Z L W K L Q W K H V X E M H F W V ¶ P H Q V W U X D O F \ F O H V Z H U H X V H G 7 K H G D W D
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
V L W H X V L Q J W K U H H E D W F K H V R I S U R G X F W 5 H V X O W V I U R P V H Y H Q S D U W L F L S D Q W V Z H U H F R Q V L G H U H G H T X L Y R F D O D Q G Z H U H H [ F O X G H G I U R P W K H D Q D O \ V L V 7 K H U H V X O W V I U R P W K H U H P D L Q L Q J R Q H K X Q G U H G I R U W \ W K U H H \f V X E M H F W V V K R Z H G D S H U F H Q W D F F X U D F \ D J D L Q V W W K H S U H G L F D W H P H W K R G R I \b b. Matrix comparison: Not applicable 3. Clinical studies: a. Clinical sensitivity: Not applicable b. Clinical specificity: Not applicable c. Other clinical supportive data (when a and b are not applicable): Not applicable 4. Clinical c ut - off : Not applicable 5. Expected values/Reference range: The expected value of day 3 urine FSH has been established in the literatur