GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE
Device Facts
| Record ID | K043144 |
|---|---|
| Device Name | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE |
| Applicant | Gen-Probe, Inc. |
| Product Code | LSL · Microbiology |
| Decision Date | Mar 14, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3390 |
| Device Class | Class 2 |
Intended Use
The APTIMA assay for Neisseria gonorrhoeae is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA from Neisseria gonorrhoeae (GC) to aid the diagnosis of gonococcal urogenital disease. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected endocervical and vaginal swab specimens; and patient-collected vaginal swab specimens* and female and male urine specimens. *Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The vaginal swab specimen collection kit is not for home use.
Device Story
In vitro diagnostic device for qualitative detection of Neisseria gonorrhoeae rRNA in clinical specimens; utilizes target capture, transcription-mediated amplification (TMA), and chemiluminescent detection. Process: specimen transport solution releases rRNA; capture oligomer binds target rRNA; magnetic particles isolate target; enzymatic amplification (TMA) replicates 119 bp 16S rRNA region; acridinium ester-labeled DNA probe hybridizes to amplicon; luminometer measures light output as Relative Light Units (RLU). Performed in clinical laboratories using Gen-Probe Leader HC+ luminometer and Target Capture System (DTS-400). Software controls detection, interpretation, and reporting. Results aid diagnosis of gonococcal urogenital disease; clinicians use output to guide patient management.
Clinical Evidence
Prospective, single-arm, multi-center study (N=2,851) across 10 sites. Evaluated sensitivity and specificity for endocervical, vaginal, urethral, and urine specimens. Sensitivity ranged from 90.0% to 100%; specificity ranged from 97.0% to 99.8%. Study identified an equivocal RLU range (100k-2M) where false positives were more frequent, leading to labeling adjustments.
Technological Characteristics
Nucleic acid amplification (TMA) and chemiluminescent detection. Materials: polypropylene/polystyrene reaction tubes, magnetic microparticles. Energy: electrical (luminometer/workstation). Connectivity: RS-232 serial output. Software: Aptima Assay software for instrument control and result interpretation. Sterilization: N/A (reagents).
Indications for Use
Indicated for detection of gonococci in male urethral, female swab (endocervical and vaginal), and urine specimens as laboratory evidence of gonococcal urogenital infection. Not indicated for testing urethral swab specimens from asymptomatic males.
Regulatory Classification
Identification
Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identify Neisseria spp. from cultured isolates. Additionally, some of these reagents consist of Neisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence of Neisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.
Predicate Devices
- Gen-Probe Aptima Combo 2 Assay (k003395)
Related Devices
- K231329 — Aptima Neisseria gonorrhoeae Assay · Hologic, Inc. · Jan 26, 2024
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ONLY TEMPLATE
A. 510(k) Number: k043144
B. Purpose for Submission: New device clearance
C. Analyte: Neisseria gonorrhoeae rRNA (119 bp region within 16S rRNA)
D. Type of Test:
Nucleic acid (rRNA) amplification with chemiluminescent detection; the test system also incorporates an initial target capture step to separate target nucleic acid from specimen. Results are qualitative based on level of photon signals (RLU) released.
E. Applicant: Gen-Probe, Inc
F. Proprietary and Established Names:
APTIMA Assay for Neisseria gonorrhoeae; nucleic acid (RNA) amplification for N. gonorrhoeae
G. Regulatory Information:
1. Regulation section: 21 CFR Part 866
2. Classification: II
3. Product Code: LSL, DNA reagents, Neisseria
4. Panel: 83 Microbiology
H. Intended Use:
1. Intended use(s):
The APTIMA assay for Neisseria gonorrhoeae is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA from Neisseria gonorrhoeae (GC) to aid the diagnosis of gonococcal urogenital disease. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected endocervical and vaginal swab specimens; and patient-collected vaginal swab specimens* and female and male urine specimens. *Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The vaginal swab specimen collection kit is not for home use.
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2. **Indication(s) for use**: detect gonococci in male urethral and female swab (endocervical and vaginal) and urine specimens as laboratory evidence of gonococcal urogenital infection. It is not indicated for testing urethral swab specimens from asymptomatic males.
3. **Special condition for use statement(s)**:
The device is for prescription use only; vaginal swab specimens are not for home use.
4. **Special instrument Requirements**:
Gen-Probe Leader HC+ luminometer, Gen-Probe Target Capture System (a customized workstation designed to handle TTU (ten tube unit) racks during magnetic separation and washing of the magnetic beads; this apparatus is alternately called DTS-400)
I. **Device Description**:
The Aptima Assay for *Neisseria gonorrhoeae* (AGC) is an in vitro diagnostic device that detects rRNA from *N. gonorrhoeae* directly in clinical specimens. The test system components are similar and in most cases the same as components used with the predicate Aptima Combo 2. Swab or urine specimens are collected and transferred into specimen transport tubes provided by the manufacturer. The transport solution contains a detergent to release the rRNA target from bacterial cells and protect it from degradation during storage. During the testing procedure, a capture oligomer isolates target rRNA (a 16S region) from the urine and swab samples by the use of a method called target capture. The capture oligomer contains a sequence complementary to a specific region of the target rRNA as well as a string of deoxyadenosine residues. The sequence specific region of the capture oligomer binds to a specific region of the target RNA. The capture oligomer:target complex is then separated out of solution by decreasing the temperature of the reaction to room temperature. This temperature reduction allows hybridization to occur between the deoxyadenosine region on the capture oligomer and the polydeoxythymidine molecules that are covalently attached to the magnetic particles. The microparticles, including the captured target molecules bound to them, are pulled to the side of the reaction vessel using magnets allowing the supernatant to be aspirated. The particles are washed to remove residual specimen matrix that may contain amplification reaction inhibitors and other potential interferents.
During the next procedural phase, complementary oligonucleotide primers anneal with and allow enzymatic amplification of the target nucleic acid strands. The Gen-Probe TMA reaction replicates a specific region of the 16S rRNA (119 bp region) from *N. gonorrhoeae* via DNA intermediates. Detection of the rRNA amplification product sequences (amplicon) is achieved using nucleic acid hybridization. A single-stranded chemiluminescent DNA probe, which is complementary to a region of the target amplicon, is labeled with an acridinium
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ester molecule. The labeled DNA probe combines with amplicon to form stable RNA:DNA hybrids. The Selection Reagent differentiates hybridized from unhybridized probe, eliminating the generation of signal from unhybridized probe. During the detection step, light emitted from the labeled RNA:DNA hybrids is measured as photon signals in a luminometer, that are reported as Relative Light Units (RLU).
The assay system includes specific reagents for the AGC assay (Amplification Reagent, Probe Reagent, Target Capture Reagent B, Probe Reconstitution Reagent, Target capture reagent, and rRNA positive and negative controls) along with component reagents used in other Aptima Assays (Enzyme Reagent, Selection Reagent, Detection reagents, etc.).
The system is performed using required equipment including pipettors, vortex mixers, water baths, Leader® HC+ Luminometer and the Target Capture System (a workstation designed to handle TTU racks during magnetic separation and washing of the magnetic beads; this setup is alternately called DTS-400). The Leader and TCS instruments/equipment are manufactured to GenProbe's specifications. Aptima Assay software installed on the Leader HC Control Unit controls sample detection, interpretation and reporting of assay results.
## J. Substantial Equivalence Information:
Predicate device name(s): Gen-Probe™ Aptima Combo 2 Assay (Chlamydia trachomatis and Neisseria Gonorrhoeae)
1. Predicate K number(s): k003395
2. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Target Nucleic acid | 16S RNA | 16S RNA |
| Target Capture | Capture oligomer has same GC binding region | |
| Positive Control | APTIMA Positive Control, GC/Negative Control, CT: 250 fg/400 μL N. gonorrhoeae rRNA and nonspecific nucleic acid, calf thymus DNA. | |
| Negative Control | APTIMA Positive Control-CT/Negative Control-GC, 5 fg/400 μL C. trachomatis rRNA and nonspecific nucleic acid, calf thymus DNA | |
| Amplification | Enzymes: reverse transcriptase and T7 RNA Polymerase | |
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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Other Reagents | Enzyme , Enzyme Reconstitution, Selection, Wash, Oil Deactivation Fluid Buffer, Auto Detect | |
| Collection & Transport Materials | APTIMA Assay Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens; APTIMA Assay Urine Specimen Collection Kit for Male and Female Urine Specimens; or APTIMA Vaginal Swab Specimen Collection Kit | |
| Instrumentation | LEADER HC+ Luminometer and Target Capture System | |
| Other Equipment | Vortexers, water baths, Pipettors, Reconstitution collars and sealing cards | |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Primer | 27-base DNA oligonucleotide | 28 base oligonucleotide |
| Promotor Primer | 64-nucleotide DNA polymer | 53 nucleotide polymer |
| Helper Probes | 36- and 40-nucleotide | Single 39-nucleotide |
| Detection probe | 20-nucleotide DNA | 24-nucleotide |
| Amplification Reagent | Amplification Reagent, GC | Combo 2 Amplification Reagent |
| Amplicon | 119 nucleotide RNA strand | 109 nucleotide RNA strand |
| Detection Method | Single Kinetic | Dual Kinetic |
| Probe Label | N-methyl acridinium ester | N-methyl 2'-methyl acridinium ester |
| Amplification Reconstitution Solution and Probe Reagent | GC | Combo 2 |
| Detection kinetics | Single algorithm | Dual algorithm |
| Software | APTIMA Assay Software with APTIMA Assay Protocol Disk | APTIMA Assay Software with APTIMA Combo 2 Protocol Disk |
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# K. Standard/Guidance Document Referenced (if applicable): NA
# L. Test Principle:
The APTIMA GC Assay combines nucleic acid (rRNA) amplification (Transcription-Mediated Amplification or TMA) with chemiluminescent detection (Hybridization Protection Assay or HPA). The test system also incorporates an initial target capture step to separate target nucleic acid from specimen.
# M. Performance Characteristics (if/when applicable):
# 1. Analytical performance:
a. Precision: Several concentrations of GC rRNA were tested repeatedly under varied conditions. This testing was done at 2 external laboratories and at the manufacturer's facility. Reproducibility for samples with organism in matrix was not assessed. The labeling includes a warning that reproducibility when testing swab and urine specimens containing target organism has not been determined.
b. Linearity/assay reportable range: RLU output values range from 0 to 12 million RLU. With analytical samples tested, highest RLU values were $\sim 7$ million. The luminometer counts the number of photons each 20 msec time interval over a 2 sec total read time,
resulting in a kinetic profile of the chemiluminescent reaction. The
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light output in each interval is reported as relative light units (RLU), which is directly proportional to the number of photons counted.
c. Traceability, Stability, Expected Values (controls, calibrators, or method) The positive control is rRNA prepared from a broth growth of Neisseria gonorrhoeae, ATCC #19424 Type Strain, and purified by sucrose gradient and chloroform-ethanol extraction. The positive control and a 1:5 dilution were used to assess assay parameters. Testing done for critical parameters in the capture, amplification, and detection stages of the AGC are shown below.
a. Capture Stage Parameters
| Step | Condition | 50 fg GC | | 250 fg GC | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | Avg RLU | Result, % Pos | Avg RLU | Result, % Pos | |
| Temp | A-T Binding | 7 °C | 3,055,000 | 100% | 4,680,000 | 100% |
| | | RT | 3,392,000 | 100% | 4,808,000 | 100% |
| | | 42 °C | 4,988,000 | 100% | 4,646,000 | 100% |
| | Target Capture | 50 °C | 2,021,000 | 100% | 3,688,000 | 100% |
| | | 55 °C | 3,281,000 | 100% | 4,359,000 | 100% |
| | | 62 °C | 3,128,000 | 100% | 4,568,000 | 100% |
| | | 95 °C | 1,029,000 | 100% | 2,964,000 | 100% |
| Time | A-T Binding | 0 min | 4,124,000 | 100% | 4,872,000 | 100% |
| | | 15 min | 4,199,000 | 100% | 4,641,000 | 100% |
| | | 30 min | 4,008,000 | 100% | 5,256,000 | 100% |
| | | 60 min | 3,698,000 | 100% | 5,098,000 | 100% |
| | Magnetic Separation | 1 min | 3,514,000 | 100% | 5,403,000 | 100% |
| | | 5 min | 3,631,000 | 100% | 5,246,000 | 100% |
| | | 9 min | 3,178,000 | 100% | 5,180,000 | 100% |
| | Target Capture | 0 min | 78,000 | 20% | 475,000 | 100% |
| | | 15 min | 2,636,000 | 100% | 4,789,000 | 100% |
| | | 30 min | 3,976,000 | 100% | 4,898,000 | 100% |
| | | 60 min | 3,899,000 | 100% | 4,771,000 | 100% |
| Volume | Control | 200 μl | 2,146,000 | 100% | 4,341,000 | 100% |
| | | 300 μl | 3,448,000 | 100% | 5,178,000 | 100% |
| | | 400 μl | 4,238,000 | 100% | 5,456,000 | 100% |
| | | 600 μl | 4,763,000 | 100% | 5,607,000 | 100% |
| | | 800 μl | 5,057,000 | 100% | 5,706,000 | 100% |
| | TCR | 0 μl | 2,770,000 | 80% | 376,000 | 40% |
| | | 50 μl | 5,033,000 | 100% | 6,079,000 | 100% |
| | | 100 μl | 4,238,000 | 100% | 5,456,000 | 100% |
| | | 150 μl | 2,906,000 | 100% | 4,394,000 | 100% |
| | | 200 μl | 1,886,000 | 100% | 3,657,000 | 100% |
| | Wash Solution | 0 ml | 2,828,000 | 100% | 3,511,000 | 80% |
| | | 0.5 ml | 3,208,000 | 100% | 4,844,000 | 100% |
| | | 1 ml | 3,338,000 | 100% | 5,054,000 | 100% |
| | | 2 ml | 2,736,000 | 100% | 4,634,000 | 100% |
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b. Amplification stage parameters
| Step | Condition | 50 fg GC | | 250 fg GC | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | Avg RLU | Result, % Pos | Avg RLU | Result, % Pos | |
| Temp | Amplification | 37°C | 3,064,000 | 100% | 4,954,000 | 100% |
| | | 42°C | 3,857,000 | 100% | 5,298,000 | 100% |
| | | 44°C | 230,000 | 100% | 339,000 | 100% |
| | Primer Binding | RT | 1,370,000 | 100% | 3,462,000 | 100% |
| | | 62 °C | 3,933,000 | 100% | 5,413,000 | 100% |
| | | 75 °C | 4,216,000 | 100% | 5,386,000 | 100% |
| | | 95 °C | 3,397,000 | 100% | 5,332,000 | 100% |
| Time | Amplification | 30 min | 1,977,000 | 100% | 3,929,000 | 100% |
| | | 60 min | 2,822,000 | 100% | 4,339,000 | 100% |
| | | 90 min | 3,010,000 | 100% | 4,561,000 | 100% |
| | Pre-Enzyme Incubation | 0 min | 2,872,000 | 100% | 4,609,000 | 100% |
| | | 5 min | 2,579,000 | 100% | 4,450,000 | 100% |
| | | 15 min | 2,452,000 | 100% | 4,790,000 | 100% |
| | Primer Binding | 0 min | 746,000 | 100% | 2,422,000 | 100% |
| | | 10 min | 3,204,000 | 100% | 4,793,000 | 100% |
| | | 30 min | 3,177,000 | 100% | 4,773,000 | 100% |
| Volume | Amplification Reagent | 25 μl | 2,965,000 | 100% | 4,761,000 | 100% |
| | | 75 μl | 3,764,000 | 100% | 5,412,000 | 100% |
| | | 100 μl | 4,298,000 | 100% | 5,182,000 | 100% |
| | | 125 μl | 3,839,000 | 100% | 5,078,000 | 100% |
| | Enzyme Reagent | 10 μl | 2,018,000 | 100% | 4,484,000 | 100% |
| | | 15 μl | 3,478,000 | 100% | 4,931,000 | 100% |
| | | 25 μl | 4,238,000 | 100% | 5,456,000 | 100% |
| | | 35 μl | 4,221,000 | 100% | 5,424,000 | 100% |
| | | 40 μl | 3,990,000 | 100% | 5,490,000 | 100% |
| | Oil Reagent | 0 μl | 4,099,000 | 100% | 5,306,000 | 100% |
| | | 200 μl | 3,947,000 | 100% | 5,707,000 | 100% |
| | | 400 μl | 3,853,000 | 100% | 5,061,000 | 100% |
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c. Detection stage parameters.
| Step | Condition | 50 fg GC | | 250 fg GC | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | Avg RLU | Result, % Pos | Avg RLU | Result, % Pos | |
| Temp | Hybridization & Selection | 60 °C | 4,160,000 | 100% | 5,273,000 | 100% |
| | | 61 °C | 4,738,000 | 100% | 5,930,000 | 100% |
| | | 62 °C | 4,015,000 | 100% | 5,514,000 | 100% |
| | | 63 °C | 4,039,000 | 100% | 5,354,000 | 100% |
| | | 64 °C | 2,937,000 | 100% | 4,262,000 | 100% |
| | Pre-Selection Incubation | 7 °C | 3,783,000 | 100% | 5,218,000 | 100% |
| | | RT | 3,854,000 | 100% | 4,992,000 | 100% |
| | | 42 °C | 3,794,000 | 100% | 4,961,000 | 100% |
| | Pre-Detection Incubation | 7 °C | 3,472,000 | 100% | 5,122,000 | 100% |
| | | RT | 3,854,000 | 100% | 4,992,000 | 100% |
| | | 60 °C | 2,292,000 | 100% | 3,398,000 | 100% |
| Time | Hybridization | 5 min | 2,165,000 | 100% | 4,540,000 | 100% |
| | | 20 min | 2,481,000 | 100% | 4,522,000 | 100% |
| | | 30 min | 2,788,000 | 100% | 4,638,000 | 100% |
| | Pre-Selection Incubation | 0 min | 2,709,000 | 100% | 3,720,000 | 100% |
| | | 5 min | 2,889,000 | 100% | 4,617,000 | 100% |
| | | 15 min | 2,792,000 | 100% | 4,702,000 | 100% |
| | Pre-Detection Incubation | 8 min | 3,462,000 | 100% | 5,259,000 | 100% |
| | | 15 min | 3,395,000 | 100% | 5,186,000 | 100% |
| | | 19 min | 3,110,000 | 100% | 4,935,000 | 100% |
| | Selection | 5 min | 3,841,000 | 100% | 6,390,000 | 100% |
| | | 7 min | 3,484,000 | 100% | 5,879,000 | 100% |
| | | 8 min | 3,941,000 | 100% | 5,981,000 | 100% |
| | | 10 min | 4,284,000 | 100% | 5,283,000 | 100% |
| | | 15 min | 2,653,000 | 100% | 4,343,000 | 100% |
| Volume | Probe Reagent | 50 μl | 2,579,000 | 100% | 2,991,000 | 100% |
| | | 100 μl | 3,947,000 | 100% | 5,707,000 | 100% |
| | | 150 μl | 4,966,000 | 100% | 7,031,000 | 100% |
| | | 200 μl | 5,973,000 | 100% | 8,481,000 | 100% |
| | Selection Reagent | 100 μl | 4,283,000 | 100% | 5,616,000 | 100% |
| | | 200 μl | 4,167,000 | 100% | 5,585,000 | 100% |
| | | 250 μl | 3,947,000 | 100% | 5,707,000 | 100% |
| | | 300 μl | 4,239,000 | 100% | 5,527,000 | 100% |
| | | 500 μl | 3,858,000 | 100% | 5,306,000 | 100% |
d. Detection limit: The kit positive control contains 250 fg N. gonorrhoeae rRNA. This control was diluted serially10-fold. Results are shown below. At a 100-fold dilution, all RLU values are in the low positive region.
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Serial dilutions of $51\mathrm{N}$ gonorrhoeae clinical isolates were prepared from McFarland preparations. Five dilutions were quantified by plate counts and microscopically with a hemocytometer. One hundred microliters $(100~\mu \mathrm{L})$ of the stock McFarland suspension was added to $3.9\mathrm{mL}$ of Swab Transport Media. After quantitation of the McFarland suspensions, the appropriate amounts of the Swab Transport Media stock that would result in 0.5, 5, and 50 cells per assay were added to KOVA-Trol/Urine Transport Media and Swab Transport Media. These dilutions were tested by APTIMA GC in triplicate. The source and characterization of these strains was not indicated. Most of the strains tested were detected with high RLU levels $(>2,000,000)$ at each of the three levels (50, 5, and 0.5 cells per assay). The labeling claims detection of 50 cells per assay (calculated to be equivalent to 362 CFU/swab or 250 CFU/mL urine). Based on these data, most strains would be detected at lower levels (5 or 0.5 cells/assay). Some strains (for example, #337) yield lower RLU values at all levels. Results for dilutions in swab transport media are shown below:
| Swab Transport Media | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Isolate # | GC Cells Per Assay | Replicate 1 | | Replicate 2 | | Replicate 3 | | Replicate 4 | |
| | | RLU | Result | RLU | Result | RLU | Result | RLU | Result |
| 337 | 50 | 393,000 | GC (+) | 497,000 | GC (+) | 440,000 | GC (+) | | |
| | 5 | 69,000 | GC (c) | 51,000 | GC (c) | 40,000 | GC (-) | | |
| | 0.5 | 16,000 | GC (-) | 10,000 | GC (-) | 15,000 | GC (-) | | |
| 343 | 50 | 687,000 | GC (+) | 930,000 | GC (+) | 1,084,000 | GC (+) | | |
| | 5 | 85,000 | GC (c) | 83,000 | GC (c) | 118,000 | GC (+) | | |
| | 0.5 | 9,000 | GC (-) | 7,000 | GC (-) | 19,000 | GC (-) | | |
| 322 | 50 | 5,907,000 | GC (+) | 6,124,000 | GC (+) | 6,075,000 | GC (+) | | |
| | 5 | 5,758,000 | GC (+) | 5,748,000 | GC (+) | 5,726,000 | GC (+) | | |
| | 0.5 | 3,898,000 | GC (+) | 3,726,000 | GC (+) | 3,591,000 | GC (+) | | |
| 323 | 50 | 3,720,000 | GC (+) | 3,459,000 | GC (+) | 4,287,000 | GC (+) | | |
| | 5 | 1,228,000 | GC (+) | 1,439,000 | GC (+) | 1,036,000 | GC (+) | | |
| | 0.5 | 116,000 | GC (+) | 103,000 | GC (+) | 106,000 | GC (+) | | |
| 324 | 50 | 1,060,000 | GC (+) | 339,000 | GC (+) | 1,108,000 | GC (+) | | |
| | 5 | 83,000 | GC (c) | 150,000 | GC (+) | 156,000 | GC (+) | | |
| | 0.5 | 21,000 | GC (-) | 14,000 | GC (-) | 4,000 | GC (-) | | |
| 329 | 50 | 5,277,000 | GC (+) | 5,304,000 | GC (+) | 5,538,000 | GC (+) | | |
| | 5 | 3,629,000 | GC (+) | 3,544,000 | GC (+) | 3,490,000 | GC (+) | | |
| | 0.5 | 423,000 | GC (+) | 481,000 | GC (+) | 775,000 | GC (+) | | |
| 332 | 50 | 5,355,000 | GC (+) | 5,274,000 | GC (+) | 5,335,000 | GC (+) | | |
| | 5 | 4,829,000 | GC (+) | 4,785,000 | GC (+) | 4,798,000 | GC (+) | | |
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| Swah Transport Media | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Isolate # | GC Cells Per Assay | Replicate 1 | | Replicate 2 | | Replicate 3 | |
| | | RLU | Result | RLU | Result | RLU | Result |
| 799 | 50 | 5,835,000 | GC (+) | 5,748,000 | GC (+) | 5,890,000 | GC (+) |
| | 5 | 5,919,000 | GC (+) | 6,118,000 | GC (+) | 5,808,000 | GC (+) |
| | 0.5 | 5,605,000 | GC (+) | 5,538,000 | GC (+) | 5,627,000 | GC (+) |
| 806 | 50 | 5,709,000 | GC (+) | 5,699,000 | GC (+) | 5,576,000 | GC (+) |
| | 5 | 5,934,000 | GC (+) | 5,821,000 | GC (+) | 5,989,000 | GC (+) |
| | 0.5 | 5,256,000 | GC (+) | 5,079,000 | GC (+) | 5,190,000 | GC (+) |
| 827 | 50 | 6,057,000 | GC (+) | 6,096,000 | GC (+) | 6,064,000 | GC (+) |
| | 5 | 5,863,000 | GC (+) | 5,930,000 | GC (+) | 5,825,000 | GC (+) |
| | 0.5 | 5,109,000 | GC(+) | 4,997,000 | GC (+) | 4,987,000 | GC (+) |
| 800 | 50 | 5,681,000 | GC (+) | 5,779,000 | GC (+) | 5,811,000 | GC (+) |
| | 5 | 5,845,000 | GC (+) | 5,918,000 | GC (+) | 5,943,000 | GC (+) |
| | 0.5 | 4,558,000 | GC (+) | 5,799,000 | GC (+) | 5,803,000 | GC (+) |
| 793 | 50 | 6,011,000 | GC (+) | 5,897,000 | GC (+) | 5,806,000 | GC (+) |
| | 5 | 5,331,000 | GC (+) | 5,579,000 | GC (+) | 5,757,000 | GC (+) |
| | 0.5 | 4,961,000 | GC (+) | 4,403,000 | GC (+) | 4,852,000 | GC (+) |
| 787 | 50 | 5,964,000 | GC (+) | 6,128,000 | GC (+) | 6,029,000 | GC (+) |
| | 5 | 5,804,000 | GC (+) | 5,720,000 | GC (+) | 5,730,000 | GC (+) |
| | 0.5 | 5,015,000 | GC (+) | 1,000 | GC (-) | 4,756,000 | GC (+) |
| 795 | 50 | 5,838,000 | GC (+) | 6,154,000 | GC (+) | 6,071,000 | GC (+) |
| | 5 | 5,641,000 | GC (+) | 5,722,000 | GC (+) | 5,886,000 | GC (+) |
| | 0.5 | 4,981,000 | GC (+) | 2,552,000 | GC (+) | 5,063,000 | GC (+) |
| 790 | 50 | 5,944,000 | GC (+) | 5,890,000 | GC (+) | 5,787,000 | GC (+) |
| | 5 | 3,857,000 | GC (+) | 5,795,000 | GC (+) | 5,657,000 | GC (+) |
| | 0.5 | 5,085,000 | GC (+) | 4,892,000 | GC (+) | 4,696,000 | GC (+) |
| 802 | 50 | 5,933,000 | GC (+) | 6,049,000 | GC (+) | 5,885,000 | GC (+) |
| | 5 | 5,361,000 | GC (+) | 5,408,000 | GC (+) | 5,488,000 | GC (+) |
| | 0.5 | 122,000 | GC (+) | 4,632,000 | GC (+) | 5,293,000 | GC (+) |
| 334 | 50 | 6,113,000 | GC (+) | 5,979,000 | GC (+) | 6,036,000 | GC (+) |
| | 5 | 5,375,000 | GC (+) | 5,252,000 | GC (+) | 5,294,000 | GC (+) |
| | 0.5 | 2,140,000 | GC (+) | 1,935,000 | GC (+) | 1,992,000 | GC (+) |
| 335 | 50 | 5,705,000 | GC (+) | 5,799,000 | GC (+) | 5,732,000 | GC (+) |
| | 5 | 3,986,000 | GC (+) | 3,781,000 | GC (+) | 3,344,000 | GC (+) |
| | 0.5 | 645,000 | GC (+) | 673,000 | GC (+) | 548,000 | GC (+) |
| 336 | 50 | 5,690,000 | GC (+) | 5,612,000 | GC (+) | 5,661,000 | GC (+) |
| | 5 | 3,327,000 | GC (+) | 3,074,000 | GC (+) | 3,900,000 | GC (+) |
| | 0.5 | 541,000 | GC (+) | 553,000 | GC (+) | 533,000 | GC (+) |
| 750 | 50 | 6,002,000 | GC (+) | 5,965,000 | GC (+) | 5,826,000 | GC (+) |
| | 5 | 4,995,000 | GC (+) | 4,859,000 | GC (+) | 4,639,000 | GC (+) |
| | 0.5 | 1,292,000 | GC (+) | 1,078,000 | GC (+) | 1,029,000 | GC (+) |
| 327 | 50 | 5,899,000 | GC (+) | 5,792,000 | GC (+) | 5,717,000 | GC (+) |
| | 5 | 5,993,000 | GC (+) | 5,934,000 | GC (+) | 5,808,000 | GC (+) |
| | 0.5 | 5,570,000 | GC (+) | 5,316,000 | GC (+) | 5,317,000 | GC (+) |
| 339 | 50 | 5,764,000 | GC (+) | 5,684,000 | GC (+) | 5,694,000 | GC (+) |
| | 5 | 5,573,000 | GC (+) | 4,556,000 | GC (+) | 5,517,000 | GC (+) |
| | 0.5 | 5,279,000 | GC (+) | 5,474,000 | GC (+) | 5,404,000 | GC (+) |
| 758 | 50 | 5,913,000 | GC (+) | 5,714,000 | GC (+) | 5,776,000 | GC (+) |
| | 5 | 5,727,000 | GC (+) | 5,856,000 | GC (+) | 5,802,000 | GC (+) |
| | 0.5 | 5,489,000 | GC (+) | 5,238,000 | GC (+) | 5,246,000 | GC (+) |
| 774 | 50 | 5,650,000 | GC (+) | 5,632,000 | GC (+) | 5,646,000 | GC (+) |
| | 5 | 5,689,000 | GC (+) | 5,575,000 | GC (+) | 5,609,000 | GC (+) |
{10}
| Swab Transport Media | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Isolate # | GC Cells Per Assay | Replicate 1 | | Replicate 2 | | Replicate 3 | |
| | | RLU | Result | RLU | Result | RLU | Result |
| | 0.5 | 3,158,000 | GC (+) | 3,023,000 | GC (+) | 2,981,000 | GC (+) |
| 344 | 50 | 4,874,000 | GC (+) | 4,947,000 | GC (+) | 4,958,000 | GC (+) |
| | 5 | 2,985,000 | GC (+) | 2,905,000 | GC (+) | 2,888,000 | GC (+) |
| | 0.5 | 568,000 | GC (+) | 566,000 | GC (+) | 504,000 | GC (+) |
| 345 | 50 | 1,689,000 | GC (+) | 1,778,000 | GC (+) | 1,769,000 | GC (+) |
| | 5 | 371,000 | GC (+) | 478,000 | GC (+) | 414,000 | GC (+) |
| | 0.5 | 23,000 | GC (-) | 15,000 | GC (-) | 34,000 | GC (-) |
| 347 | 50 | 4,810,000 | GC (+) | 4,871,000 | GC (+) | 4,820,000 | GC (+) |
| | 5 | 2,855,000 | GC (+) | 3,220,000 | GC (+) | 3,073,000 | GC (+) |
| | 0.5 | 542,000 | GC (+) | 615,000 | GC (+) | 583,000 | GC (+) |
| 3063 | 50 | 1,747,000 | GC (+) | 5,852,000 | GC (+) | 5,788,000 | GC (+) |
| | 5 | 4,747,000 | GC (+) | 4,984,000 | GC (+) | 4,916,000 | GC (+) |
| | 0.5 | 696,000 | GC (+) | 1,274,000 | GC (+) | 960,000 | GC (+) |
| 3064 | 50 | 5,831,000 | GC (+) | 5,809,000 | GC (+) | 5,671,000 | GC (+) |
| | 5 | 5,195,000 | GC (+) | 5,204,000 | GC (+) | 5,331,000 | GC (+) |
| | 0.5 | 1,960,000 | GC (+) | 2,020,000 | GC (+) | 2,024,000 | GC (+) |
| 3091 | 50 | 5,981,000 | GC (+) | 5,863,000 | GC (+) | 5,887,000 | GC (+) |
| | 5 | 5,438,000 | GC (+) | 5,356,000 | GC (+) | 5,380,000 | GC (+) |
| | 0.5 | 2,323,000 | GC (+) | 2,350,000 | GC (+) | 2,325,000 | GC (+) |
| 3092 | 50 | 5,654,000 | GC (+) | 5,433,000 | GC (+) | 5,679,000 | GC (+) |
| | 5 | 2,849,000 | GC (+) | 1,859,000 | GC (+) | 3,773,000 | GC (+) |
| | 0.5 | 648,000 | GC (+) | 609,000 | GC (+) | 1,000 | GC (-) |
| 3100 | 50 | 5,900,000 | GC (+) | 5,912,000 | GC (+) | 5,936,000 | GC (+) |
| | 5 | 4,845,000 | GC (+) | 5,168,000 | GC (+) | 4,790,000 | GC (+) |
| | 0.5 | 2,297,000 | GC (+) | 2,211,000 | GC (+) | 2,285,000 | GC (+) |
| 3101 | 50 | 5,271,000 | GC (+) | 5,303,000 | GC (+) | 5,436,000 | GC (+) |
| | 5 | 4,345,000 | GC (+) | 4,241,000 | GC (+) | 4,415,000 | GC (+) |
| | 0.5 | 1,532,000 | GC (+) | 1,576,000 | GC (+) | 1,491,000 | GC (+) |
| 3103 | 50 | 5,979,000 | GC (+) | 5,852,000 | GC (+) | 5,702,000 | GC (+) |
| | 5 | 5,224,000 | GC (+) | 4,926,000 | GC (+) | 5,169,000 | GC (+) |
| | 0.5 | 29,000 | GC (-) | 2,053,000 | GC (+) | 1,953,000 | GC (+) |
| 3047 | 50 | 6,020,000 | GC (+) | 6,171,000 | GC (+) | 6,009,000 | GC (+) |
| | 5 | 5,550,000 | GC (+) | 701,000 | GC (+) | 5,747,000 | GC (+) |
| | 0.5 | 5,078,000 | GC (+) | 5,662,000 | GC (+) | 5,352,000 | GC (+) |
| 3024 | 50 | 5,634,000 | GC (+) | 5,743,000 | GC (+) | 5,826,000 | GC (+) |
| | 5 | 5,442,000 | GC (+) | 5,520,000 | GC (+) | 5,581,000 | GC (+) |
| | 0.5 | 5,628,000 | GC (+) | 5,468,000 | GC (+) | 5,574,000 | GC (+) |
| 3045 | 50 | 635,000 | GC (+) | 5,899,000 | GC (+) | 6,001,000 | GC (+) |
| | 5 | 5,892,000 | GC (+) | 5,566,000 | GC (+) | 205,000 | GC (+) |
| | 0.5 | 5,510,000 | GC (+) | 5,693,000 | GC (+) | 5,601,000 | GC (+) |
| 3043 | 50 | 5,826,000 | GC (+) | 5,745,000 | GC (+) | 6,011,000 | GC (+) |
| | 5 | 6,031,000 | GC (+) | 4,175,000 | GC (+) | 5,868,000 | GC (+) |
| | 0.5 | 3,102,000 | GC (+) | 5,353,000 | GC (+) | 5,307,000 | GC (+) |
| 813 | 50 | 5,777,000 | GC (+) | 5,928,000 | GC (+) | 7,856,000 | GC (+) |
| | 5 | 5,812,000 | GC (+) | 6,031,000 | GC (+) | 5,839,000 | GC (+) |
| | 0.5 | 5,128,000 | GC (+) | 5,090,000 | GC (+) | 4,519,000 | GC (+) |
| 801 | 50 | 5,846,000 | GC (+) | 5,697,000 | GC (+) | 5,834,000 | GC (+) |
| | 5 | 5,609,000 | GC (+) | 5,741,000 | GC (+) | 5,751,000 | GC (+) |
| | 0.5 | 5,284,000 | GC (+) | 5,157,000 | GC (+) | 5,158,000 | GC (+) |
# 2. Comparison studies: NA
{11}
# 3. Clinical studies:
The data in support of this submission is from a prospective, single-arm, multi-center clinical study to determine the performance characteristics and precision of the Aptima GC (AGC) Assay for the detection of Neisseria gonorrhoeae GC in female endocervical swab, patient-collected vaginal swab (PVS), clinician-collected vaginal swab (CVS), and first catch urine (FCU) specimens and in male urethral swab and first catch urine specimens.
The first study enrolled 2,851 symptomatic and asymptomatic, male and female subjects from Ob-Gyn clinic settings and STD, teen and family planning clinics from eight geographically diverse, and high and low prevalence sites; a ninth site performed specimen testing using the BD Assay, and a tenth site, GenProbe, performed specimen testing using the AC2 Assay as well as the alternate TMA amplification assay for GC. Five specimens were collected from each female subject enrolled in the study: two endocervical swabs, one FCU specimen, one PVS, and one CVS. Three different specimens were collected from each male subject enrolled in the study: two urethral swabs and one patient-collected FCU specimen. The clinical study evaluated the performance characteristics of the AGC Assay in terms of sensitivity, specificity and predictive values. Four specimen results were used to determine each male or female subject's GC infected status. An "infected status +" is any one assay positive with a positive by a 2nd assay with a different target and a different format (regardless of specimen).
Summary of Performance of the Aptima GC Assay:
| Specimen type | Symptoms | N | Sensitivity (CI) | Specificity(CI) | Prevalence | PPV | NPV |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Male urethral swab | Symptomatic | 575 | 99.4 (96.8-100) | 97.5 (95.5-98.8) | 29.7% | 94% | 99.70% |
| | Asymptomatic | 742 | 100 (69.2-100) | 97.0 (95.5-98.1) | 1.30% | 31% | 100% |
| Male urine | Symptomatic | 576 | 99.4 (96.8-100) | 99.0 (97.5-99.7) | 29.70% | 97.70% | 99.70% |
| | Asymptomatic | 745 | 90.0 (55.5-99.7) | 99.3 (98.4-99.8) | 1.30% | 64% | 99.90% |
| Female endocervical swab | Symptomatic | 805 | 98.1 (89.9-100) | 98.9 (97.9-99.5) | 6.40% | 86.70% | 99.90% |
| | Asymptomatic | 635 | 95.2 (76.2-99.9) | 99.2 (98.1-99.7) | 3.10% | 80% | 99.80% |
| Female urine | Symptomatic | 810 | 90.6 (79.3-96.9) | 99.7 (99.0-100) | 5.90% | 96% | 96.80% |
| | Asymptomatic | 639 | 95.5 (77.2-99.9) | 99.8 (99.1-100) | 3.20% | 95% | 99.80% |
| Patient-collected Vag Swab | Asymptomatic | 629 | 100 (83.9-100) | 99.3 (98.3-99.8) | 3.30% | 84% | 100% |
| | All | 142 | 97.3 (90.6- | 99.2 (98.5- | 5.20% | 86.70% | 99.9% |
| | | | 99.8 (98.1-100) | 99.8 (99.1-100) | | | |
| | All | 143 | 97.3 (90.6- | 99.8 (99.1-100) | 3.30% | 84% | 100% |
{12}
The clinical evaluation with testing swabs from asymptomatic males raised concerns about false positivity. Out of 746 asymptomatic male patients who had urethral swab specimens tested by AGC, there were 10 infected individuals defined by the reference assays and an additional 22 patients that had positive AGC results; the consequent positive predictive value is $31\%$ for AGC testing of urethral swabs from asymptomatic males. The use of swab specimens for asymptomatic males was not indicated in the final labeling.
a. Clinical cut-off: During the clinical evaluation, a 100,000 RLU cutoff used to separate positive AGC results from equivocal results. The majority of infected patients in all groups had AGC RLU results $>2,000,000$ . Overall there was a preponderance of presumed false positives with RLU levels between 100,000 and 2,000,000 (See below). The labeling advises that AGC tests with RLU results in that range are more likely to be falsely positive. The numbers of presumed false positives in different measurement ranges was broken out as follows:
Breakout by specimen type - distribution of FP&TP across "positive" range
| neg=1220 (3FN) | 100k-1,000k | 1-2 M | 2-3 M | 3 -4 M | 4-5 M | 5-6 M | >6M |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Endocx swab | | | | | | | |
| Total n | 12 | 1 | 1 | 7 | 1 | 15 | 47 |
| # FP | 11 | 1 | 0 | 0 | 0 | 0 | 0 |
| #TP | 1 | 0 | 1 | 7 | 1 | 15 | 47 |
| Proportion TP | 8.3% | | | 100 | 100 | 100 | 100 |
| neg=1446 (2 FN) | 100k-1,000k | 1-2 M | 2-3 M | 3 -4 M | 4-5 M | 5-6 M | >6M |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Vag Swab(CC) | | | | | | | |
| Total n | 6 | 3 | 1 | 6 | 1 | 19 | 48 |
| # FP | 5 | 3 | 0 | 1 | 0 | 2 | 0 |
| #TP | 1 | 0 | 1 | 5 | 1 | 17 | 48 |
| Proportion TP | 16.7% | 0 | | 83.3% | | 89.5% | 100% |
| neg=1422 (3FN) | 100k-1,000k | 1-2 M | 2-3 M | 3 -4 M | 4-5 M | 5-6 M | >6M |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Vag | | | | | | | |
{13}
| Swab(PC) | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Total n | 9 | 0 | 2 | 9 | 1 | 20 | 42 |
| # FP | 7 | 0 | 1 | 2 | 0 | 1 | 1 |
| #TP | 2 | 0 | 1 | 7 | 1 | 19 | 41 |
| Proportion TP | 22.2% | | 50% | 77.8% | | 95% | 97.6% |
| neg=1057 (5FN) | 100k-1,000k | 1-2 M | 2-3 M | 3 -4 M | 4-5 M | 5-6 M | >6M |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Urethral swab | | | | | | | |
| Total n | 28 | 3 | 3 | 5 | 4 | 31 | 139 |
| # FP | 25 | 1 | 2 | 2 | 0 | 0 | 0 |
| #TP | 3 | 2 | 1 | 3 | 4 | 31 | 139 |
| Proportion TP | 10.7% | 66.7% | 33.3% | 60.0% | 100% | 100% | 100% |
| neg=1074 (9FN) | 100k-1,000k | 1-2 M | 2-3 M | 3 -4 M | 4-5 M | 5-6 M | >6M |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Male Urine | | | | | | | |
| Total n | 5 | 4 | 2 | 1 | 8 | 36 | 133 |
| # FP | 5 | 2 | 1 | 1 | 0 | 0 | 0 |
| #TP | 0 | 2 | 1 | 0 | 8 | 36 | 133 |
| Proportion TP | 0% | 50% | 50% | | 100% | 100% | 100% |
| neg=1257 (10FN) | 100k- 1,000k | 1-2 M | 2-3 M | 3 -4 M | 4-5 M | 5-6 M | >6M |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Female Urine | | | | | | | |
| Total n | 9 | 0 | 7 | 3 | 6 | 13 | 34 |
| # FP | 2 | 0 | 0 | 1 | 0 | 0 | 0 |
| #TP | 7 | 0 | 7 | 2 | 6 | 13 | 34 |
| Proportion TP | 77.8% | 0 | 100% | 66.7% | 100% | 100% | 100% |
Note: calculations not done when fewer than 2 results in any one region. Gray areas are where numbers although mostly small suggest an equivocal region.
b. Expected values/Reference range: As discussed above, an RLU region immediately above the designated equivocal region, was determined to be a low measurement region in which results were more likely falsely positive. The distribution of RLU responses from all specimen types tested in the clinical study are shown below:
{14}
Figure 2 Frequency of RLU Distribution for the APTIMA GC Assay
d. Instrument Name: Leader HC Luminometer and Target Capture System (specifications shown below)
{15}
Page 16 of 18
| Component | Specifications |
| --- | --- |
| Main Workstation | 5 in. high x 19 in. wide x 19 in. deep (approximately 35.5 cm high x 48.25 cm wide x 48.25 cm deep).
Requires approximately 12 in. (30 cm) of space above the unit to maneuver the Aspiration Manifold dispense handles. |
| Dispense Manifold and Station | 4 in. high x 9 in. wide x 10 in. deep (approximately 9 cm high x 22.75 cm wide x 25.5 cm deep). |
| Vacuum Trap | 18 in. high x 15 in. wide x 7 in. deep (approximately 45.75 cm high x 38 cm wide x 17.75 cm deep). |
| Vacuum Pump Requirement | Absolute vacuum and open-flow rate specifications are dependent upon altitude. Contact Technical Service for the appropriate specifications. |
| Weight | Workstation & Aspiration Manifold: 23.6 lbs. (10.7 kg)
Dispense Station & Manifold: 4.8 lbs. (2.2 kg)
Vacuum Trap: 16.4 lbs. (7.5 kg)
Vacuum Pump: 30 lbs. (13.6 kg)
Total weight: 74. 8 lbs. (34 kg) |
| Voltage | 115V 60 Hz |
| Injector Volumes | Provides delivery of 1.0 ml +/- 10% volume of fluid from the Wash Reagent Bottle via an operator-activated Dispense Manifold, without splash-back. |
| Operating Environment | Operates in a controlled environment of 15° C to 30° C and 20% to 90% relative humidity, non-condensing. |
{16}
Page 17 of 18
# 7.1 LEADER HC+ Luminometer Specifications
| Component | Specifications |
| --- | --- |
| Dimensions | 19.1 cm H x 45.7 cm W x 67.3 cm D
(7.5 in. H x 18.0 in. W x 26.5 in. D) |
| Weight | 23 kg (50 lb) |
| Power Requirements | 100-140VAC 50-60 Hz, OR 200-250VAC 50-60 Hz
Main supply fluctuation not to exceed ±10% of nominal voltage. Transient over-voltages according to installation Categories I, II, and III.
For main supply, the minimum and normal category is II. |
| Operating Environment | Indoor use; maximum relative humidity of 10 to 90%; temperature range 15°C to 30°C unless specified otherwise in assay package inserts; altitude up to 2000m |
| Injector Volumes | 200 μL, Accuracy ±10%, Coefficient of Variation ≤2% CV |
| Instrument Precision Capability | Photon (see glossary) counting < 2% CV at 1000 RLU or greater |
| Serial Output | RS-232, 9600 baud; 8 data bits; odd parity; 1 stop bit |
| Test Tubes | Due to the special requirements of luminescence measurements, not every type or brand of reaction tube can be used (see the assay package insert). Use individual polypropylene or polystyrene 12 x 75mm tubes for pump volume verification. |
| Cassettes | Processes up to 25 Cassettes per run, each capable of holding ten (10), 12 x 75 mm tubes, or one TTU. |
Note: Specifications are subject to change without notice.
# O. System Descriptions:
1. Modes of Operation:
The Aptima software is resident in an internal hard drive and performs an array of functions including: hardware control, measurement, patient sample identification, systems parameters, communication, self-diagnosis and maintenance.
2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ x ☐ or No ☐
3. Specimen Identification: no comments
4. Specimen Sampling and Handling: no comments
{17}
Page 18 of 18
5. Calibration: no comments
6. Quality Control: no comments
P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
NA
Q. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
R. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
