K190223 · Microbiologics, Inc. · PMN · May 8, 2019 · Microbiology
Device Facts
Record ID
K190223
Device Name
Cepheid Xpert CT/NG Control Panel
Applicant
Microbiologics, Inc.
Product Code
PMN · Microbiology
Decision Date
May 8, 2019
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 866.3920
Device Class
Class 2
Indications for Use
The Cepheid Xpert® CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert® CT/NG assay on the GeneXpert® Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert® CT/NG Control Panel is not intended to replace manufacturer controls provided with the device.
Device Story
External quality control material; consists of six individually packaged swabs (positive and negative). Positive swabs contain cultured, inactivated Chlamydia trachomatis and Neisseria gonorrhoeae; negative swabs contain human epithelial cells. Used in clinical laboratories to monitor performance of Cepheid Xpert CT/NG assay on GeneXpert Instrument System. Controls processed like patient samples; monitor extraction, amplification, and detection steps. Healthcare providers use results to verify assay performance and ensure validity of patient test results. Benefits include improved confidence in diagnostic accuracy for CT/NG testing.
Clinical Evidence
No clinical data. Bench testing only. Reproducibility study conducted across three sites with six operators over five days using three lots of control material. Results showed 100% agreement with expected qualitative results for all targets (CT, NG2, NG4, SPC, SAC). Stability studies (accelerated and real-time) and in-use stability (up to 6 hours) confirmed product integrity and performance consistency.
Technological Characteristics
Lyophilized swab format; contains inactivated microorganisms (C. trachomatis, N. gonorrhoeae) and human epithelial cells. Stabilized with preservatives. Designed for use with Cepheid GeneXpert System. No electronic components; non-sterile.
Indications for Use
Indicated for use as an external quality control material for laboratory personnel performing qualitative nucleic acid testing for Chlamydia trachomatis and Neisseria gonorrhoeae using the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. For in vitro diagnostic and prescription use only.
Regulatory Classification
Identification
An assayed quality control material for clinical microbiology assays is a device indicated for use in a test system to estimate test precision or to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device consists of single or multiple microbiological analytes intended for use with either qualitative or quantitative assays.
Special Controls
An assayed quality control material for clinical microbiology assays must comply with the following special controls: (1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate: (i) Analyte concentration; Expected values: (ii) Analyte source: (iii) (iv) Base matrix; (v) Added components; (vi) Safety and handling information; and, (vii) Detailed instructions for use. (2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including: (i) Description of the process for value assignment and validation. (ii) Description of the protocol(s) used to establish stability. (iii) Line data establishing precision/reproducibility. (iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance. (v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method. (vi) Where applicable, detailed documentation related to studies for surrogate controls. (3) Premarket notification submissions must include an adequate mitigation (e.g., realtime stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling. (4) Your 21 CFR 809.10 compliant labeling must include the following: (i) The intended use in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(b)(2) compliant labeling must include the following: (A) Assayed control material analyte(s); (B) Whether the material is intended for quantitative or qualitative assays: (C) Stating if the material is a surrogate control; (D)The system(s), instrument(s), or test(s) for which the quality control material is intended. (ii) The intended use in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(b)(2) compliant labeling must include the following statement: "This product is not intended to replace manufacturer controls provided with the device." (iii)A limiting statement that reads "Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements."
*Classification.* Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate:
(i) Analyte concentration;
(ii) Expected values;
(iii) Analyte source;
(iv) Base matrix;
(v) Added components;
(vi) Safety and handling information; and
(vii) Detailed instructions for use.
(2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including:
(i) Description of the process for value assignment and validation.
(ii) Description of the protocol(s) used to establish stability.
(iii) Line data establishing precision/reproducibility.
(iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance.
(v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method.
(vi) Where applicable, detailed documentation related to studies for surrogate controls.
(3) Premarket notification submissions must include an adequate mitigation (e.g., real-time stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling.
(4) Your 21 CFR 809.10 compliant labeling must include the following:
(i) The intended use of your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following:
(A) Assayed control material analyte(s);
(B) Whether the material is intended for quantitative or qualitative assays;
(C) Stating if the material is a surrogate control; and
(D) The system(s), instrument(s), or test(s) for which the quality control material is intended.
(ii) The intended use in your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following statement: “This product is not intended to replace manufacturer controls provided with the device.”
(iii) A limiting statement that reads “Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.”
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1
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
A. 510(k) Number:
K190223
B. Purpose for Submission:
To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System.
C. Measurand:
Nucleic acids from inactivated Chlamydia trachomatis and Neisseria gonorrhoeae (positive control) and from human epithelial cells (negative control).
D. Type of Test:
The Cepheid Xpert CT/NG Control Panel is an external assayed quality control material (positive and negative) designed to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae in genitourinary specimens when used with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument System.
E. Applicant:
Microbiologics, Inc.
F. Proprietary and Established Names:
Trade Name: Cepheid Xpert CT/NG Control Panel
G. Regulatory Information:
1. Regulation section:
21 CFR 866.3920, Assayed quality control material for clinical microbiology assays
2. Classification:
Class II (Special Controls)
3. Product code:
{1}
PMN Assayed external control material for microbiology nucleic acid amplification assays
4. Panel:
(83) Microbiology
H. Intended Use:
1. Intended use:
The Cepheid Xpert CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control.
The Cepheid Xpert CT/NG Control Panel is not intended to replace manufacturer controls provided with the device.
2. Indication(s) for use:
Same as Intended Use.
3. Special conditions for use statement(s):
For in vitro diagnostic use only.
For prescription use only.
3. Special instrument requirements:
Cepheid Xpert Instrument System
I. Device Description:
The Cepheid Xpert CT/NG Control Panel is a quality control material provided to the customer as six individually packaged positive and negative swabs. Each positive swab consists of inactivated Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) microorganisms. Each negative swab consists of human epithelial cells. The positive swabs were prepared with cultured, inactivated and quantified stocks of CT and NG. The negative swabs were prepared from human cells derived from a cultured cell line, certified for sterility, and quantified in cells/mL.
2
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J. Substantial Equivalence Information:
1. Predicate device name(s):
Cepheid Xpert GBS LB Control Panel
2. Predicate 510(k) number(s):
K182472
3. Comparison with predicate:
| | K190223 | K182472 (Predicate) |
| --- | --- | --- |
| Device Trade Name | Cepheid Xpert CT/NG Control Panel | Cepheid Xpert GBS LB Control Panel |
| Similarities | | |
| Intended Use | The Cepheid Xpert CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert CT/NG Control Panel is not intended to replace manufacturer controls provided with the device. | External assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. |
| Physical Format | Swabs | Swabs |
| Composition | Inactivated microorganisms | Inactivated microorganisms |
| Test System | Cepheid GeneXpert System | Cepheid GeneXpert System |
| Directions for Use | Process like patient sample | Process like patient sample |
| Assay Steps Monitored | Extraction, amplification, and detection | Extraction, amplification, and detection |
| Number of Targets Monitored in One Assay | Multiple | Multiple |
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| Differences | | |
| --- | --- | --- |
| Assay Compatibility | Cepheid Xpert CT/NG Assay | Cepheid Xpert GBS LB Assay |
| Positive Control | Chlamydia trachomatis
Neisseria gonorrhoeae | Streptococcus agalactiae |
| Negative Control | Human epithelial cells | Lactobacillus acidophilus |
## K. Standard/Guidance Document Referenced (if applicable):
Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009. Evaluation of Precision of Quantitative Measurement Methods: Approved Guideline. CLSI Document EP05-A3, 2014.
## L. Test Principle:
Not applicable; this is control material to monitor performance of an in vitro diagnostic test. The test principle defaults to the Cepheid Xpert CT/NG assay, K121710.
## M. Performance Characteristics:
1. Analytical performance:
a. Reproducibility:
The Cepheid Xpert CT/NG Control Panel was evaluated at three testing sites with two operators at each site (total of six operators). Three lots of the control material were tested with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument, over five days. Each positive and negative control was tested in three replicates on each day. There were seven ERROR results (assay aborted due to instrument or reagent problem) and one INVALID result (failure of the internal control/s). Those samples were retested using a new control swab according to the Instructions for Use. All testing utilized the Xpert Vaginal/Endocervical Swab Specimen Collection kit. The Cepheid Xpert CT/NG Assay detects one target for CT) and two different targets for NG (NG2 and NG4). Both NG targets need to be positive for the Xpert CT/NG Assay to return a positive NG result.
The qualitative results from the reproducibility study are summarized below.
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Positive Control
| Target | % Agreement with Expected Results, by Test Site | | | |
| --- | --- | --- | --- | --- |
| | Site 1^{1,3} | Site 2^{2,3} | Site 3 | Overall |
| C. trachomatis | 31/31
(100%) | 31/31
(100%) | 30/30
(100%) | 92/92
(100%) |
| N. gonorrhoeae
(NG2) | 31/31
(100%) | 31/31
(100%) | 30/30
(100%) | 92/92
(100%) |
| N. gonorrhoeae
(NG4) | 31/31
(100%) | 31/31
(100%) | 30/30
(100%) | 92/92
(100%) |
| SPC | 31/31
(100%) | 31/31
(100%) | 30/30
(100%) | 92/92
(100%) |
SPC: Sample Processing Control
1. Three ERROR results were observed; in all cases a new control was retested and the expected results were obtained.
2. Two ERROR results and one INVALID result were obtained; in all cases a new control was retested and the expected results were obtained.
3. More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls.
Negative Control
| Target | % Agreement with Expected Results, by Test Site | | | |
| --- | --- | --- | --- | --- |
| | Site 1^{1,2,3*} | Site 2^{1,2,3} | Site 3 | Overall |
| SAC | 33/33
(100%) | 34/34
(100%) | 30/30
(100%) | 97/97
(100%) |
| SPC | 33/33
(100%) | 34/34
(100%) | 30/30
(100%) | 97/97
(100%) |
SAC: Sample Adequacy Control;
SPC: Sample Processing Control
1. Two ERROR results were observed; in all cases a new control was retested and the expected results were obtained.
2. One Negative Control at site 1 and two Negative Control at Site 2 generated a positive result for NG2 target, however, the qualitative results were negative in each case because the Xpert CT/NG Assay requires both NG2 and NG4 targets to be positive in order to return a positive result for NG. In accordance with the assay protocol, the work area was cleaned and the controls were retested.
3. More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls.
The calculated average Ct score values and the associated standard deviation (SD) and percent coefficient of variation (% CV) across the three testing sites obtained in the reproducibility study are shown below.
Positive Control
| Target | N | Mean (Ct) | SD | %CV |
| --- | --- | --- | --- | --- |
| C. trachomatis | 92 | 31.8 | 1.204 | 3.78 |
| N. gonorrhoeae NG2 | 92 | 32.1 | 1.290 | 4.02 |
| N. gonorrhoeae NG4 | 92 | 31.4 | 1.223 | 3.89 |
| SPC | 92 | 31.5 | 0.219 | 0.70 |
SPC: Sample Processing Control
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Negative Control
| Target | N | Mean (Ct) | SD | %CV |
| --- | --- | --- | --- | --- |
| Human Epithelial Cells (SAC) | 97 | 27.9 | 0.988 | 3.54 |
| SPC | 97 | 31.5 | 0.233 | 0.74 |
SAC: Sample Adequacy Control
SPC: Sample Processing Control
b. Linearity/assay reportable range:
Not applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability:
Not applicable
Stability:
1. Shelf life stability of the Cepheid Xpert CT/NG Control Panel was initially evaluated through an accelerated study with three lots of the controls. The product was placed into chambers at elevated temperatures: 43°C, 53°C and 63°C. Each lot was tested in 4 replicates at each of the following time points: Day 0, Day 14, Day 28, and Day 42. The stability of the product was evaluated by calculating the change (delta) in mean Ct value at each time point for the three microbial targets (CT, NG2 and NG4) from the mean Ct value obtained at Day 0. Both Positive and Negative Controls were tested.
For Positive Control, the change in Ct score for all targets, across the three lots, ranged from 2.2% to 9.3% when stored at 43°C, from 1.6% to 9.7% when stored at 53°C, and from 2.9% to 14.4% when stored at 63°C. All valid tests generated expected (positive) results for all analytes.
For Negative Control, the change in Ct score for the human epithelial cells target, across the three lots, ranged from 2.2% to 6.0% when stored at 43°C, from 3.7% to 6.8% when stored at 53°C, and from 3.3% to 12.8% when stored at 63°C. All valid tests generated expected (negative) results.
The data from the accelerated stability study with three lots of the product is summarized below.
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Positive Control
| | | 43°C | | | 53°C | | | 63°C | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Day | Mean (Ct) | Delta (Ct) | % Change | Mean (Ct) | Delta (Ct) | % Change | Mean (Ct) | Delta (Ct) | % Change |
| Lot 1 | | | | | | | | | | |
| CT | 0 | 30.6 | | | 30.6 | | | 30.6 | | |
| | 14 | 31.6 | 1.1 | 3.4 | 31.6 | 1.1 | 3.4 | 32.0 | 1.4 | 4.5 |
| | 28 | 31.8 | 1.2 | 4.0 | 31.1 | 0.5 | 1.6 | 32.2 | 1.6 | 5.3 |
| | 42 | 31.5 | 0.9 | 3.1 | 32.8 | 2.2 | 7.1 | 32.1 | 1.6 | 5.1 |
| NG2 | 0 | 30.4 | | | 30.4 | | | 30.4 | | |
| | 14 | 31.3 | 0.9 | 3.0 | 31.7 | 1.3 | 4.1 | 31.9 | 1.5 | 5.0 |
| | 28 | 31.8 | 1.4 | 4.4 | 31.3 | 0.9 | 2.9 | 31.8 | 1.4 | 4.7 |
| | 42 | 31.4 | 1.0 | 3.2 | 32.4 | 2.0 | 6.5 | 31.7 | 1.3 | 4.2 |
| NG4 | 0 | 30.0 | | | 30.0 | | | 30.0 | | |
| | 14 | 30.9 | 0.9 | 2.9 | 31.2 | 1.2 | 4.0 | 31.7 | 1.7 | 5.6 |
| | 28 | 31.4 | 1.4 | 4.7 | 30.9 | 0.9 | 2.9 | 31.2 | 1.3 | 4.2 |
| | 42 | 30.8 | 0.8 | 2.8 | 31.8 | 1.8 | 5.9 | 31.5 | 1.5 | 5.0 |
| Lot 2 | | | | | | | | | | |
| CT | 0 | 31.2 | | | 31.2 | | | 31.2 | | |
| | 14 | 32.1 | 0.9 | 3.0 | 33.5 | 2.4 | 7.5 | 33.3 | 2.1 | 6.7 |
| | 28 | 33.5 | 2.4 | 7.5 | 32.2 | 1.0 | 3.2 | 33.5 | 2.3 | 7.5 |
| | 42 | 33.1 | 1.9 | 6.0 | 33.3 | 2.1 | 6.8 | 34.5 | 3.3 | 10.7 |
| NG2 | 0 | 31.1 | | | 31.1 | | | 31.08 | | |
| | 14 | 32.4 | 1.3 | 4.3 | 33.7 | 2.6 | 8.3 | 33.05 | 2.0 | 6.4 |
| | 28 | 34.0 | 2.9 | 9.3 | 32.8 | 1.7 | 5.4 | 34.08 | 3.0 | 9.7 |
| | 42 | 33.1 | 2.0 | 6.5 | 34.1 | 3.0 | 9.7 | 35.23 | 4.2 | 13.4 |
| NG4 | 0 | 30.8 | | | 30.8 | | | 30.8 | | |
| | 14 | 31.9 | 1.1 | 3.6 | 33.3 | 2.5 | 8.0 | 32.5 | 1.7 | 5.5 |
| | 28 | 33.1 | 2.3 | 7.5 | 32.8 | 2.0 | 6.3 | 33.4 | 2.6 | 8.3 |
| | 42 | 32.3 | 1.5 | 4.8 | 33.4 | 2.6 | 8.4 | 35.2 | 4.4 | 14.4 |
| Lot 3 | | | | | | | | | | |
| CT | 0 | 31.1 | | | 31.1 | | | 31.1 | | |
| | 14 | 31.9 | 0.8 | 2.7 | 32.3 | 1.2 | 3.9 | 32.0 | 0.9 | 3.0 |
| | 28 | 32.0 | 0.9 | 3.0 | 32.5 | 1.4 | 4.4 | 32.7 | 1.7 | 5.3 |
| | 42 | 32.5 | 1.4 | 4.5 | 32.1 | 1.0 | 3.2 | 33.3 | 2.2 | 7.0 |
| NG2 | 0 | 31.2 | | | 31.2 | | | 31.2 | | |
| | 14 | 31.9 | 0.7 | 2.2 | 32.4 | 1.2 | 3.9 | 32.3 | 1.1 | 3.5 |
| | 28 | 32.5 | 1.3 | 4.2 | 32.7 | 1.5 | 4.6 | 32.8 | 1.6 | 5.0 |
| | 42 | 32.3 | 1.1 | 3.5 | 32.5 | 1.3 | 4.0 | 33.4 | 2.2 | 7.1 |
| NG4 | 0 | 30.7 | | | 30.7 | | | 30.7 | | |
| | 14 | 31.7 | 1.0 | 3.3 | 32.0 | 1.3 | 4.2 | 31.6 | 0.9 | 2.9 |
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8
| | 28 | 31.8 | 1.2 | 3.7 | 32.5 | 1.9 | 6.0 | 32.5 | 1.9 | 6.0 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 42 | 31.9 | 1.2 | 4.0 | 31.8 | 1.1 | 3.7 | 32.5 | 1.8 | 5.8 |
## Negative Control (SAC)
| | | 43°C | | | 53°C | | | 63°C | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Day | Mean (Ct) | Delta (Ct) | % Change | Mean (Ct) | Delta (Ct) | % Change | Mean (Ct) | Delta (Ct) | % Change |
| Lot 1 | 0 | 27.2 | | | 27.2 | | | 27.2 | | |
| | 14 | 28.4 | 1.2 | 4.5 | 28.2 | 1.0 | 3.7 | 29.1 | 1.9 | 6.9 |
| | 28 | 28.7 | 1.6 | 5.7 | 28.5 | 1.3 | 4.7 | 29.6 | 2.4 | 8.9 |
| | 42 | 28.8 | 1.6 | 6.0 | 28.2 | 1.1 | 3.9 | 30.1 | 2.9 | 10.8 |
| Lot 2 | 0 | 26.6 | | | 26.6 | | | 26.6 | | |
| | 14 | 27.2 | 0.6 | 2.2 | 27.9 | 1.3 | 4.9 | 28.4 | 1.8 | 6.8 |
| | 28 | 27.5 | 0.9 | 3.2 | 28.2 | 1.6 | 5.8 | 28.9 | 2.2 | 8.4 |
| | 42 | 27.5 | 0.9 | 3.2 | 28.4 | 1.8 | 6.8 | 30.0 | 3.4 | 12.8 |
| Lot 3 | 0 | 26.6 | | | 26.6 | | | 26.6 | | |
| | 14 | 27.5 | 0.9 | 3.3 | 28.2 | 1.6 | 5.8 | 27.5 | 0.9 | 3.3 |
| | 28 | 27.2 | 0.6 | 2.2 | 28.1 | 1.5 | 5.5 | 28.8 | 2.2 | 8.1 |
| | 42 | 27.5 | 0.9 | 3.4 | 27.9 | 1.3 | 4.8 | 28.7 | 2.0 | 7.6 |
2. Real time shelf stability data was submitted for 5 months of storage at 2-8°C and at 25°C. One lot of the product was tested in 4 replicates prior to placing the product in the controlled temperature chambers (T=0). After 5 months (T=1), Positive and Negative Controls were tested with the Cepheid Xpert CT/NG Assay. The stability was assessed by calculating the mean Ct of the 4 replicates at each time point. The difference (Δ) of the average Ct means between the two time points, across all the measured targets (i.e., CT, NG2, NG4 and SAC), ranged from 0 to 0.7, indicating no loss of DNA after 5 months of storage at 2-8°C and at 25°C. The summary of the data collected after 5 months of storage is shown below.
### Real Time Stability after 5 months of Storage
| | | 2-8°C | | 25°C | |
| --- | --- | --- | --- | --- | --- |
| Target | Mean T=0 | Mean T=1 | Δ Ct | Mean T-1 | Δ Ct |
| CT | 30.6 | 30.8 | 0.2 | 30.7 | 0.1 |
| NG2 | 30.4 | 34.4 | 0.0 | 30.5 | 0.1 |
| NG4 | 30.0 | 30.4 | 0.4 | 30.7 | 0.7 |
| SAC (Negative Control) | 27.2 | 27.5 | 0.3 | 27.6 | 0.4 |
3. An in-use stability of the hydrated Control swabs (i.e., placed in the Transport Reagent Tube from the Xpert Vaginal/Endocervical Specimen Collection kit) was evaluated at room temperature (21°C) over the period of 6 hours. The controls
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were tested in three replicates immediately after hydration $(t = 0)$ , and then again at 4 hours, and at 6 hours. All samples produced expected results after 4 and 6 hours, with minimal variation. The summary of the data collected over 6 hours is shown below.
In-Use Stability Study Using Swab Specimen Collection Kit
| | Target | N | Mean (Ct) | SD | %CV |
| --- | --- | --- | --- | --- | --- |
| Positive Control | C. trachomatis | 9 | 30.9 | 0.357 | 1.16 |
| | N. gonorrhoeae NG2 | 9 | 30.4 | 0.186 | 0.61 |
| | N. gonorrhoeae NG4 | 9 | 30.1 | 0.331 | 1.10 |
| Negative Control | Human Epithelial Cells | 9 | 27.2 | 0.194 | 0.72 |
4. A similar study was performed with control swabs hydrated in the Transport Reagent Tube from the Xpert Urine Specimen Collection Kit. Due to the low fluid volume in the Transport Reagent Tube from the Xpert Urine Specimen Collection Kit, it is necessary for the user to add $1.5\mathrm{mL}$ of nuclease-free water to properly hydrate the swab. This is part of the Cepheid Xpert CT/NG Control Panel instructions for use.
In-Use Stability Study Using Urine Specimen Collection Kit
| | Target | N | Mean (Ct) | SD | %CV |
| --- | --- | --- | --- | --- | --- |
| Positive Control | C. trachomatis | 9 | 32.9 | 0.537 | 1.63 |
| | N. gonorrhoeae NG2 | 9 | 32.3 | 0.464 | 1.44 |
| | N. gonorrhoeae NG4 | 9 | 32.1 | 0.675 | 2.10 |
| Negative Control | Human Epithelial Cells | 9 | 28.3 | 0.450 | 1.59 |
# 5. Shipping Stability
The Cepheid CT/NG Controls are packaged in sealed foil pouches with desiccants to prevent effects of high humidity. However, the product may be exposed and affected by high temperatures. The product is shipped by FedEx for delivery in two days, however, delays may be encountered. The effect of exposure to high temperatures was evaluated at $43^{\circ}\mathrm{C}$ after 14 days (the worst-case delay scenario) in the accelerated stability study described above. The observed change in Ct values (a measure of product deterioration) was less than $5\%$ , ranging from $2.2\%$ to $4.3\%$ for the positive control (for all the microbial targets), and from $2.2\%$ to $4.5\%$ for the negative control (human cells target), across three lots of the product.
# Expected Values:
The Cepheid CT/NG Control Panel consists of qualitative positive and negative controls. The following are the expected assay results.
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| Control | Expected Assay Result | Interpretation |
| --- | --- | --- |
| Positive Control | CT Detected
NG Detected | CT target and NG target DNA sequences are detected. |
| Negative Control | CT Not Detected
NG Not Detected | Neither CT nor NG target DNA sequences are detected. |
d. Detection limit:
Not applicable.
e. Analytical Specificity:
Not applicable.
f. Assay cut-off:
Not applicable.
2. Comparison studies:
a. Method comparison with predicate device:
Not applicable.
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.
{10}
4. Clinical cut-off:
Not applicable.
N. Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision
11
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
