(155 days)
No
The description details a standard nucleic acid amplification test (NAAT) using Strand Displacement Amplification (SDA) technology and fluorescence detection. The results are determined by comparing fluorescence measurements to a predetermined threshold value and applying an "automated algorithm" for reporting. While this involves automation and an algorithm, there is no indication of learning, training data, or adaptive capabilities characteristic of AI/ML. The "automated algorithm" appears to be a rule-based system for interpreting the fluorescence signals against a fixed threshold.
No
This device is for diagnostic purposes, aiding in the detection of Neisseria gonorrhoeae DNA to diagnose gonococcal urogenital disease, not for treating or preventing it.
Yes
This device is clearly identified as a diagnostic device in its "Intended Use / Indications for Use" section, stating it is "intended for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease."
No
The device is a diagnostic assay that utilizes reagents and a specific hardware system (BD Viper System) for amplification and detection of DNA. While it involves data analysis (calculating peak fluorescence and applying an algorithm), it is fundamentally a hardware-dependent in vitro diagnostic device, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is for the "direct, qualitative detection of Neisseria gonorrhoeae DNA" in various human specimens (swabs and urine). This is a classic definition of an in vitro diagnostic test, as it is performed on samples taken from the human body to provide information about a person's health status.
- Device Description: The description details the reagents and process used to analyze the specimens outside of the body (in vitro). It describes the use of microwells, enzymes, and a fluorescent reader to detect the target DNA.
- Clinical Performance Studies: The document includes details about clinical performance studies conducted on human specimens to evaluate the assay's sensitivity and specificity in diagnosing gonococcal urogenital disease. This is a requirement for IVD devices to demonstrate their clinical utility.
- Aid in Diagnosis: The intended use states that the assay is intended "to aid in the diagnosis of gonococcal urogenital disease." This further confirms its role as a diagnostic tool.
Therefore, based on the provided information, the BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay, when tested with the BD Viper™ System in Extracted Mode, uses Strand Displacement Amplification technology for the direct, qualitative detection of Neisseria gonorrhoeae DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens (both UPT and Neat). The assay is also intended for use with gynecological specimens collected in BD SurePath™ Preservative Fluid using an aliquot that is removed prior to processing for the BD SurePath™ Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.
Product codes
LSL
Device Description
The BD ProbeTec GC Q* Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently-labeled detector probe. The reagents for SDA are dried in two separate disposable microwells: the Priming Microwell contains the amplification primers, fluorescently-labeled detector probe, nucleotides and other reagents necessary for amplification, while the Amplification Microwell contains the two enzymes (a DNA polymerase and a restriction endonuclease) that are required for SDA. The BD Viper 10 System pipettes a portion of the purified DNA solution from each Extraction Tube into a Priming Microwell to rehydrate the contents. After a brief incubation, the reaction mixture is transferred to a corresponding, pre-warmed Amplification Microwell which is sealed to prevent contamination and then incubated in one of the two thermally-controlled fluorescent readers. The presence or absence of N. gonorrhoeae DNA is determined by calculating the peak fluorescence (Maximum Relative Fluorescent Units (MaxRFU)) over the course of the amplification process and by comparing this measurement to a predetermined threshold value.
In addition to the fluorescent probe used to detect amplified N. gonorrhoeae target DNA, a second labeled oligonucleotide is incorporated in each reaction. The Extraction Control (EC) oligonucleotide is labeled with a different dye than that used for detection of the N. gonorrhoeae -specific target and is used to confirm the validity of the extraction process. The EC is dried in the Extraction Tubes and is rehydrated upon addition of the specimen and extraction reagents. At the end of the extraction process, the EC fluorescence is monitored by the BD Viper System and an automated algorithm is applied to both the EC and N. gonorrhoede -specific signals to report results as positive, negative, or EC failure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Female endocervical, male urethral, vaginal, urogenital
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician, clinical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Endocervical swab specimens and BD SurePath specimens were collected from 1728 compliant female subjects attending family planning, OB/GYN, and sexually transmitted disease clinics at eleven geographically diverse clinical sites in North America. Subjects were classified as symptomatic if they reported symptoms such as dysuria, coital pain/difficulty/bleeding, abnormal vaginal discharge, or pelvic/uterine/adnexal pain. Subjects were classified as asymptomatic if they did not report symptoms.
Three randomized endocervical swab specimens and a BD SurePath specimen were collected from each female subject. The three reference endocervical swabs were tested with the BD ProbeTec ET CT/GC/AC assay, the BD ProbeTec GC Q* assay, and another commercially available NAAT (Nucleic Acid Amplification Test). Sensitivity and specificity for BD SurePath specimens were calculated by comparing results to a patient infected status (PIS) algorithm. The designation of positive or negative PIS was based on the endocervical swab specimen results from the three reference methods. At least two positive reference results were required to establish a subject as PIS-positive. At least two negative reference results were required to establish a subject as PIS-negative.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance Characteristics:
Endocervical swab specimens and BD SurePath specimens were collected from 1728 compliant female subjects attending family planning, OB/GYN, and sexually transmitted disease clinics at eleven geographically diverse clinical sites in North America.
Summary of GC Q* Assay Performance for BD SurePath Specimens Compared to Patient Infected Status (By Symptomatic Status):
- Asymptomatic: N=1157, Sensitivity 100.0% (32/32), Specificity 99.8% (1123/1125), PPV 93.5%, NPV 100.0%.
- Symptomatic: N=558, Sensitivity 100.0% (19/19), Specificity 100.0% (539/539), PPV 100.0%, NPV 100.0%.
- Total: N=1715, Sensitivity 100.0% (51/51), Specificity 99.9% (1662/1664), PPV 96.9%, NPV 100.0%.
Reproducibility Study:
A reproducibility study of the BD Viper System using the BD ProbeTec GC Q* Assay was evaluated for Liquid Based Cytology (LBC) specimens at three clinical sites. A panel of simulated specimens comprising CT and GC organisms seeded into LBC Specimen Dilution Tubes and uninoculated LBC Specimen Dilution Tubes were used. Nine replicates of each panel member were tested every day for five days on each BD Viper System.
Summary of Reproducibility Data for LBC Specimens on the BD Viper System for the GC Q* Assay:
- GC Cells/mL = 0: 100.0% Correct (135/135)
- GC Cells/mL = 100: 100.0% Correct (135/135)
- GC Cells/mL = 250: 100.0% Correct (135/135)
Characterization of System Reproducibility at Target Levels below the Analytical Limit of Detection for the GC Q* Assay for LBC Specimens:
- Dilution of Analytical LOD 1:10: 74.1% Positive (100/135), 25.9% Negative (35/135)
- Dilution of Analytical LOD 1:100: 8.9% Positive (12/135), 91.1% Negative (123/135)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity, Specificity, PPV, NPV, % Correct, % Positive, % Negative
Predicate Device(s)
BD ProbeTec TM Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay (K081825), Gen-Probe APTIMA Assay for Neisseria gonorrhoeae (AGC) (K062440)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3390
Neisseria spp. direct serological test reagents.(a)
Identification. Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identifyNeisseria spp. from cultured isolates. Additionally, some of these reagents consist ofNeisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence ofNeisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, 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.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the BD logo. The logo consists of a stylized sun and human figure on the left, followed by the letters "BD" in bold, sans-serif font. Below the letters, there is a tagline that reads "Helping all people live healthy lives" in a smaller font.
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
510(k) Summary
| Applicant | BD Diagnostic Systems
7 Loveton Circle
Sparks, MD 21152 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NOV 13 2009 |
| Establishment Registration No. 1119779 | |
| Contact Person | Saba Modjarrad
tel. 410-316-4685
fax. 410-316-4499
saba_modjarrad@bd.com |
| Summary Date | June 10, 2009 |
| Proprietary Name | BD ProbeTec TM Neisseria gonorrhoeae (GC) Q* Amplified
DNA Assay |
| Generic Name | DNA Reagents, Neisseria |
| Classification | Class II |
| Classification Name | Neisseria spp. direct serological test reagents |
| Regulation Number | 866.3390 |
| Product Code | LSL |
| Predicate Devices | BD ProbeTec TM Neisseria gonorrhoeae (GC) Q* Amplified
DNA Assay (K081825),
Gen-Probe APTIMA Assay for Neisseria gonorrhoeae (AGC)
(K062440) |
Device Description
The BD ProbeTec GC Q* Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently-labeled detector probe. The reagents for SDA are dried in two separate disposable microwells: the Priming Microwell contains the amplification primers, fluorescently-labeled detector probe, nucleotides and other reagents necessary for amplification, while the Amplification Microwell contains the two enzymes (a DNA polymerase and a restriction endonuclease) that are required for SDA. The BD Viper 10 System pipettes a portion of the purified DNA solution from each Extraction Tube into a Priming Microwell to rehydrate the contents. After a brief incubation, the reaction mixture is transferred to a corresponding, pre-warmed Amplification Microwell which is sealed to prevent contamination and then incubated in one of the two thermally-controlled fluorescent readers. The presence or absence of N. gonorrhoeae DNA is determined by calculating the peak
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BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
fluorescence (Maximum Relative Fluorescent Units (MaxRFU)) over the course of the amplification process and by comparing this measurement to a predetermined threshold value.
In addition to the fluorescent probe used to detect amplified N. gonorrhoeae target DNA, a second labeled oligonucleotide is incorporated in each reaction. The Extraction Control (EC) oligonucleotide is labeled with a different dye than that used for detection of the N. gonorrhoeae -specific target and is used to confirm the validity of the extraction process. The EC is dried in the Extraction Tubes and is rehydrated upon addition of the specimen and extraction reagents. At the end of the extraction process, the EC fluorescence is monitored by the BD Viper System and an automated algorithm is applied to both the EC and N. gonorrhoede -specific signals to report results as positive, negative, or EC failure.
Intended Use
The BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay, when tested with the BD Viper™ System in Extracted Mode, uses Strand Displacement Amplification technology for the direct, qualitative detection of Neisseria gonorrhoeae DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens (both UPT and Neat). The assay is also intended for use with gynecological specimens collected in BD SurePath™ Preservative Fluid using an aliquot that is removed prior to processing for the BD SurePath™ Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.
Summarv and Principles of Operation
When used with the BD Viper System, the BD ProbeTec GC Q* Amplified DNA Assay involves automated extraction of DNA from clinical specimens through the chemical lysis of cells, followed by binding of DNA to para-magnetic particles, washing of the bound nucleic acid and elution in an amplification-compatible buffer. When present, N. gonorrhoeae DNA is then detected by Strand Displacement Amplification (SDA) of a specific target sequence in the presence of a fluorescently labeled detector probe.
Analytical Performance Characteristics
Limit of Detection (Analytical Sensitivity)
The Limits of Detection (LODs) for the GC O* Assay with Neisseria gonorrhoeae strain ATCC 19424 in BD SurePath specimens when extracted on the BD Viper System were determined to be ≤ 100 GC cells per mL. The GC Q* Assay on the BD Viper System in extracted mode was able to detect 17 GC strains with > 95% proportion positive at a concentration of 50 cells per mL in clean diluted BD SurePath Preservative Fluid.
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Image /page/2/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of a stylized sun-like symbol with a human figure at the bottom left, followed by the letters "BD" in bold font. Below the letters, there is a tagline that reads "Helping all people live healthy lives".
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
Interfering Substances
Potential interfering substances which may be encountered in BD SurePath specimens were extracted from diluted BD SurePath matrix in the absence and presence of GC target (300 GC cells/mL) and tested with the BD ProbeTec GC Q* Amplified DNA Assay on the BD Viper System. Results are summarized in Table 2.
Table 2 Interfering Substances
| Interpretation | BD SurePath |
|---|---|
| No Interference Observed | Blood (≤ 1%) |
| Seminal Fluid | |
| Mucus | |
| Over The Counter vaginal products and contraceptives | |
| Hemorrhoidal cream | |
| Prescription vaginal treatments | |
| Leukocytes (1x106 cells/mL) | |
| 1x106 EB/mL Chlamydia trachomatis |
Clinical Performance Characteristics
Endocervical swab specimens and BD SurePath specimens were collected from 1728 compliant female subjects attending family planning, OB/GYN, and sexually transmitted disease clinics at eleven geographically diverse clinical sites in North America. Subjects were classified as symptomatic if they reported symptoms such as dysuria, coital pain/difficulty/bleeding, abnormal vaginal discharge, or pelvic/uterine/adnexal pain. Subjects were classified as asymptomatic if they did not report symptoms.
Three randomized endocervical swab specimens and a BD SurePath specimen were collected from each female subject. The three reference endocervical swabs were tested with the BD ProbeTec ET CT/GC/AC assay, the BD ProbeTec GC Q* assay, and another commercially available NAAT (Nucleic Acid Amplification Test). Sensitivity and specificity for BD SurePath specimens were calculated by comparing results to a patient infected status (PIS) algorithm. The designation of positive or negative PIS was based on the endocervical swab specimen results from the three reference methods. At least two positive reference results were required to establish a subject as PIS-positive. At least two negative reference results were required to establish a subject as PIS-negative. Sensitivity and specificity by symptomatic status are presented in Table 4.
The distribution of cervical sampling devices used in the clinical study according to clinical collection site is summarized in Table 3.
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BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
Summary of Cervical Sampling Devices Used in the BD SurePath Specimen Table 3 Clinical Study
| Clinical Collection Site Number | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cervical Sampling | ||||||||||||
| Device Used | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | Total |
| Broom-Type | ||||||||||||
| Device | 54 | 50 | 511 | 18 | 374 | 0 | 127 | 0 | 0 | 71 | 0 | 1205 |
| Spatula/Cytobrush | 0 | 25 | 0 | 0 | 182 | 112 | 32 | 24 | 103 | 8 | 37 | 523 |
Table 4 GC Q* Assay Performance for BD SurePath Specimens Compared to Patient Infected Status (By Symptomatic Status)
| | | Performance Compared to Patient Infected
Status | | | | | | |
|-----------------------|-------|----------------------------------------------------|---------------------|----------------------|---------------------|--------|--------|------------------------|
| Symptomatic
Status | N | Sensitivity | 95% C.I. | Specificity | 95%
C.I. | PPV | NPV | Error
Initial/Final |
| A | 1157 | 100.0%
(32/32) | (89.1% -
100.0%) | 99.8%
(1123/1125) | (99.4% -
100.0%) | 93.5% | 100.0% | 2/0 |
| S | 558 | 100.0%
(19/19) | (82.4% -
100.0%) | 100.0%
(539/539) | (99.3% -
100.0%) | 100.0% | 100.0% | 0/0 |
| Total | 1715' | 100.0%
(51/51) | (93.0% -
100.0%) | 99.9%
(1662/1664) | (99.6% -
100.0%) | 96.9% | 100.0% | 2/0 |
1 Of the 1728 compliant female subjects did not have a GC Q assay result for the BD SurePath specimen, therefore the final data analysis included 1715 compliant female subjects.
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BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
A total of 1715 GC Q* Assay results from BD SurePath specimens was evaluated from eleven geographically diverse clinical sites. A frequency distribution of the initial MaxRFU values for the GC Q+ assay is shown in Figure A. .
Frequency Distribution of MaxRFU for the GC Q* Assay (BD SurePath Figure A Specimens)
Image /page/4/Figure/5 description: The image is a bar graph showing frequency on the y-axis and MaxRFU on the x-axis. The first bar, representing 0-49 MaxRFU, has a frequency of 1659. The other bars have much lower frequencies, with 50-99 at 2, 100-124 at 1, and >=800 at 53, while the rest are at 0.
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Image /page/5/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of two parts: a graphic symbol on the left and the letters "BD" on the right. Below the letters, there is a tagline that reads "Helping all people live healthy lives." The graphic symbol appears to be a stylized representation of a person with arms outstretched under a sun-like shape.
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
Reproducibility
A reproducibility study of the BD Viper System using the BD ProbeTec GC Q* Assay was also evaluated for Liquid Based Cytology (LBC) specimens at three clinical sites on one BD Viper System per site. A panel of simulated specimens comprising CT and GC organisms seeded into LBC Specimen Dilution Tubes containing LBC medium was tested with the BD ProbeTec GC O Assay. Uninoculated LBC Specimen Dilution Tubes containing LBC medium were used for the GC negative samples. Nine replicates of each panel member were tested every day for five days on each BD Viper System. The data are summarized in Table 5.
Two additional levels were included in the panels to characterize the reproducibility of test results (i.e., proportion positive or negative) at target levels below the analytical Limit of Detection (LOD) of the BD ProbeTec GC Q* Assay. These additional specimens comprised CT and GC organisms seeded into LBC Specimen Dilution Tubes containing LBC medium at dilutions of 1:10 and 1:100 of the respective analytical LODs of each analyte. These levels were selected to fall within the dynamic range of the analytical LOD curves for the BD ProbeTec CT Of and GC Q* assays. Nine replicates of each panel member were tested every day for five days across the three BD Viper Systems. The data are summarized in Table 6.
| | | | | | Within Run | | Between
Runs
Within Site | | Between
Site | |
|---------------|----------------|---------------------|---------------------|----------------|------------|--------|--------------------------------|------|-----------------|-------|
| CT
EB's/mL | GC
Cells/mL | % Correct | 95% CI | Mean
MaxRFU | SD | %CV | SD | %CV | SD | %CV |
| 0 | 0 | 100.0%
(135/135) | (97.3% -
100.0%) | 1.21 | 4.00 | 330.38 | 0.00 | 0.00 | 0.00 | 0.00 |
| 30 | 0 | 100.0%
(135/135) | (97.3% -
100.0%) | 0.98 | 7.47 | 761.30 | 0.00 | 0.00 | 0.17 | 17.04 |
| 0 | 100 | 100.0%
(135/135) | (97.3% -
100.0%) | 1982.77 | 83.92 | 4.23 | 0.00 | 0.00 | 0.00 | 0.00 |
| 30 | 250 | 100.0%
(135/135) | (97.3% -
100.0%) | 1983.66 | 87.76 | 4.42 | 0.00 | 0.00 | 24.80 | 1.25 |
| 75 | 100 | 100.0%
(135/135) | (97.3% -
100.0%) | 1920.14 | 81.94 | 4.27 | 59.45 | 3.10 | 0.00 | 0.00 |
Summary of Reproducibility Data for LBC Specimens on the BD Viper Table 5 System for the GC O* Assay
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Image /page/6/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of two parts: a graphic symbol on the left and the letters "BD" on the right. The graphic symbol appears to be a stylized representation of a person with arms raised under a sun-like burst. Below the letters "BD" is the tagline "Helping all people live healthy lives" in a smaller font.
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
Characterization of System Reproducibility at Target Levels below the Table 6 Analytical Limit of Detection for the GC Q* Assay for LBC Specimens
| Dilution
of
Analytical
LOD | % Positive | 95% CI
(Positive) | MaxRFU
Mean
(Positive) | % Negative | 95% CI
(Negative) | MaxRFU
Mean
(Negative) |
|-------------------------------------|----------------|----------------------|------------------------------|----------------|----------------------|------------------------------|
| 1:10 | 74.1 (100/135) | (65.8 - 81.2) | 1159.2 | 25.9 (35/135) | (18.8 - 34.2) | 21.2 |
| 1:100 | 8.9 (12/135) | (4.7 - 15.0) | 1136.5 | 91.1 (123/135) | (85.0 - 95.3) | 6.6 |
Conclusions
The analytical and clinical study results for the BD ProbeTec Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay with BD SurePath specimens support the determination of substantial equivalence in accordance with the intended use as stated in the product labeling.
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
NOV 1 3 2009
Ms. Saba Modjarrad Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
K091730 Re: K091750
Trade/Device Name: BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay Regulation Number: 21 CFR 866.3390 Regulation Name: Neisseria spp. direct serological test reagents Regulatory Class: Class II Product Code: LSL Dated: November 5, 2009 Received: November 6, 2009
Dear Ms. Saba Modjarrad:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we mare revelour your boomer on (e) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, enerolded to the Medical Device Amendments, or to devices that have been reclassified in the chance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require accordalice with the provisions of the reason (PMA). You may, therefore, market the device, subject to approval or a promations of the Act. The general controls provisions of the Act include the general ochiles pro revistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be IT your device is classinod (300 able to) into emajor regulations affecting your device can be found in Title Subject to such architems (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the 1 carar states and regarding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 Act 3 requirements, moraans, on manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
8
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jallåtyne
Hoivat, M. Sc., Ph.D.
Sally A. Hojvat, M. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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