BD GENEOHM STAPHSR ASSAY
Device Facts
| Record ID | K071026 |
|---|---|
| Device Name | BD GENEOHM STAPHSR ASSAY |
| Applicant | Bd Diagnostics (Geneohm Sciences Canada, Inc) |
| Product Code | NQX · Microbiology |
| Decision Date | Dec 20, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.1640 |
| Device Class | Class 2 |
Intended Use
The BD GeneOhm™ StaphSR Assay is a qualitative in vitro diagnostic test for the rapid detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) directly from positive blood culture. The assay utilizes polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the real-time detection of the amplified DNA. The assay is performed on Gram positive cocci, identified by Gram stain, from positive blood cultures. The BD GeneOhm™ StaphSR Assay is not intended to monitor treatment for MRSA/SA infections. Subculturing of positive blood cultures is necessary for further susceptibility testing.
Device Story
Device performs qualitative detection of SA and MRSA from positive blood culture bottles. Input: 2µL of positive blood culture. Process: chemical/physical lysis (beads/heat); PCR amplification of SA-specific target, MRSA-specific SCCmec junction, and internal control; real-time detection via fluorogenic molecular beacon probes (FAM for MRSA, TexasRed for SA, TET for IC). Output: fluorescence data interpreted by SmartCycler® software to provide qualitative result. Used in clinical laboratories; operated by trained personnel. Results assist clinicians in rapid identification of SA/MRSA, potentially accelerating appropriate antimicrobial therapy.
Clinical Evidence
Clinical trials at five sites compared BD GeneOhm™ StaphSR to reference culture/ID-AST methods. Total sample size 1,186. Results showed high agreement: MRSA positive agreement 100% (95% CI 15.8-100%), negative agreement 98.2-100%. S. aureus positive agreement 98.8-100%, negative agreement 96.5-100%. Unresolved/invalid rates were low.
Technological Characteristics
Molecular diagnostic assay using PCR and fluorogenic molecular beacon probes. Targets: SA-specific sequence, SCCmec junction, and internal control. Instrumentation: SmartCycler® system. Lysis: chemical/physical (beads/heat). Detection: real-time fluorescence (FAM, TexasRed, TET). Shelf life: 12 months for lysis kit at 25°C/5°C; 12 weeks for sealed pouches at 35°C/45°C.
Indications for Use
Indicated for use on Gram positive cocci, identified by Gram stain, from positive blood cultures. Not intended to monitor treatment for MRSA/SA infections. Subculturing of positive blood cultures is necessary for further susceptibility testing.
Regulatory Classification
Identification
An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.
Predicate Devices
- Remel Staphaurex Latex Agglutination Test (K851949)
- BBL (BD) Oxacillin Screen Agar (K863821)
- BD Phoenix Automated ID/AST System (K020322, K023301)
- BD GeneOhm™ MRSA Assay (K042357)
Related Devices
- K101879 — XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10 · Cepheid · Jul 28, 2010
- K132468 — MRSA/SA ELITE MGB, ELITE MGB SOFTWARE · Elitechgroup Epoch Biosciences · Oct 17, 2013
- K130894 — XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE · Cepheid · Jun 20, 2013
- K093346 — BD GENEOHM MRSA ACP ASSAY · Bd Diagnostics (Geneohm Sciences, Inc.) · Dec 15, 2009
Submission Summary (Full Text)
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## 510(k) Summary: K071026
December 18, 2007
# BD Diagnostics, BD GeneOhm™ StaphSR Assay Positive Blood Culture Indication
| Submitted by: | BD Diagnostics (GeneOhm Sciences Canada Inc.)<br>2050, boul. René-Lévesque O, 4e étage<br>Sainte-Foy, Québec G1V 2K8 CANADA |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact (US Agent): | Raymond Boulé<br>Sr. Director, RA/QM/RC<br>BD Diagnostics - GeneOhm<br>6146 Nancy Ridge Drive<br>San Diego, CA 92121 USA |
| | DEC 2 0 2007 |
| Name of Device: | |
| Trade Name: | BD GeneOhm™ StaphSR Assay |
| Common Name: | <i>Staphylococcus aureus</i> and Methicillin-resistant<br><i>Staphylococcus aureus</i> detection assay |
| Classification Name: | System, Test, Genotypic Detection, resistant and non-<br>resistant markers, <i>Staphylococcus</i> colonies |
| Predicate Device: | Performance:<br>Remel Staphaurex Latex Agglutination Test (K851949)<br>BBL (BD) Oxacillin Screen Agar (K863821)<br>BD Phoenix Automated ID/AST System (K020322,<br>K023301) |
| | Technology:<br>GeneOhm Sciences Canada BD GeneOhm™ MRSA Assa<br>(K042357) |
Device Description:
### Intended Use:
The BD GeneOhm™ StaphSR Assay is a qualitative in vitro diagnostic test for the rapid detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) directly from positive blood culture. The assay utilizes polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the real-time detection of the amplified DNA. The assay is performed on Gram positive cocci, identified by Gram stain, from positive blood cultures. The BD GeneOhm™ StaphSR Assay is not intended to monitor treatment for MRSA/SA infections. Subculturing of positive blood cultures is necessary for further susceptibility testing.
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### Test Description:
To test a positive blood culture, an aliquot of the culture media is transferred into a sample buffer tube and lysed. Following specimen lysis, amplification of the targets (MRSA: a S. aureus specific target and a sequence near the insertion site of the Staphylococcal Cassette Chromosome mec (SCCmec); SA: another S. aureus specific sequence] occurs in the presence of either or both targets. Amplification of the IC, a DNA fragment of 335-bp including a 277-bp sequence not found in S. aureus or MRSA, also takes place unless PCR inhibitory substances are present.
The amplified DNA targets are detected with molecular beacon probes, hairpin-forming singlestranded oligonucleotides labelled at one end with a quencher and at the other end with a fluorescent reporter dye (fluorophore). In the absence of target, the fluorescence is quenched. In the presence of target, the hairpin structure opens upon beacon/target hybridization, resulting in emission of fluorescence. For the detection of MRSA amplicon, the molecular beacon probe contains the fluorophore FAM at the 5' end and the non-fluorescent quencher moiety DABCYL at the opposite end of the oligonucleotide. For the detection of S. aureus amplicon, the molecular beacon probe is labelled with the fluorophore TexasRed at the 5' end and the quencher DABCYL at the 3' end. For the detection of the IC amplicon, the molecular beacon probe contains the fluorophore TET at the 5' end and the quencher DABCYL at the 3' end, Each beacon-target hybrid fluoresces at a wavelength characteristic of the fluorophore used in the particular molecular beacon probe. The amount of fluorescence at any given cycle, or following cycling, depends on the amount of specific amplicon present at that time. The SmartCycler software simultaneously monitors the fluorescence emitted by each beacon probe, interprets all data, and provides a final result at the end of the cycling program.
### Substantial Equivalence:
The BD Diagnostics BD GeneOhm™ StaphSR Assay is substantially equivalent in technology to the currently marketed GeneOhm Sciences Canada BD GeneOhm™ MRSA Assay (K042357). The BD GeneOhm™ StaphSR Assay contains additional primers and molecular beacon probes to detect Staphylococcus aureus.
The GeneOhm BD GeneOhm™ StaphSR Assay is substantially equivalent in performance to the Remel Staphaurex Latex Agglutination Test (K851949) for detection of Staphylococcus aureus; the culture medium BBL (BD) Oxacillin Screen Agar (K863821) for detection of methicillin-resistant Staphylococcus aureus; and the BD Phoenix Automated ID/AST System (K020322, K023301) for detection of both Staphylococcus aureus and methicillin-resistant Staphylococcus aureus. These methods were used as the reference methods in the clinical trials.
Clinical trials were performed at five sites to evaluate the performance of the BD GeneOhm™ StaphSR Assay. The results are summarized in Tables 1-5:
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Table 1. Results obtained with BD GeneOhm™ StaphSR for MRSA and S. aureus in comparison to the reference methods
S. aureus
| Site 1 | | | | | | | | | |
|---------------------------|---|-------------------------------|-----|-----|---------------------------|---|-------------------------------|-----|-----|
| | | Culture/ID-AST System 1 | | | | | Culture/ID-AST System 1 | | |
| BD<br>GeneOhm™<br>StaphSR | + | + | - | | BD<br>GeneOhm™<br>StaphSR | + | + | - | |
| | | 61 | 5 | 66 | | | 99 | 0 | 99 |
| | | 0 | 380 | 380 | | | 0 | 347 | 347 |
| | | 61 | 385 | 446 | | | 99 | 347 | 446 |
| Site 2 | | | | | | | | | |
| | | Culture/ID-AST System 2 | | | | | Culture/ID-AST System 2 | | |
| BD<br>GeneOhm™<br>StaphSR | + | + | - | | BD<br>GeneOhm™<br>StaphSR | + | + | - | |
| | | 24 | 2 | 26 | | | 40 | 1 | 41 |
| | | 0 | 107 | 107 | | | 0 | 92 | 92 |
| | | 24 | 109 | 133 | | | 40 | 93 | 133 |
| Site 3 | | | | | | | | | |
| | | Culture/Oxacillin Screen Agar | | | | | Culture/Oxacillin Screen Agar | | |
| BD<br>GeneOhm™<br>StaphSR | + | + | - | | BD<br>GeneOhm™<br>StaphSR | + | + | - | |
| | | 21 | 0 | 21 | | | 83 | 0 | 83 |
| | | 0 | 211 | 211 | | | 0 | 149 | 149 |
| | | 21 | 211 | 232 | | | 83 | 149 | 232 |
| Site 4 | | | | | | | | | |
| | | Culture/ID-AST System 3 | | | | | Culture/ID-AST System 3 | | |
| BD<br>GeneOhm™<br>StaphSR | + | + | - | | BD<br>GeneOhm™<br>StaphSR | + | + | - | |
| | | 48 | 4 | 52 | | | 84 | 7 | 91 |
| | | 0 | 234 | 234 | | - | 1 | 194 | 195 |
| | | 48 | 238 | 286 | | | 85 | 201 | 286 |
| Site 5 | | | | | | | | | |
| | | Culture/PBP2' Latex | | | | | Culture/PBP2' Latex | | |
| BD<br>GeneOhm™<br>StaphSR | + | + | - | | BD<br>GeneOhm™<br>StaphSR | + | + | - | |
| | | 2 | 0 | 2 | | | 8 | 0 | 8 |
| | | 0 | 84 | 84 | | - | 0 | 78 | 78 |
| | | 2 | 84 | 86 | | | 8 | 78 | 86 |
MRSA
#### Performance obtained with BD GeneOhm™ StaphSR for MRSA (by investigational site) in comparison to the Table 2. reference method.
| Site | MRSA<br>prevalence | MRSA Positive<br>% Agreement<br>(95% Cl) 1 | MRSA Negative<br>% Agreement<br>(95% CI) 1 | Overall<br>% Agreement |
|--------|--------------------|--------------------------------------------|--------------------------------------------|------------------------|
| Site 1 | 13.7% (61/446) | 100%(61/61) (94.1%-100%) | 98.7% (380/385) (97.0% - 99.6%) | 98.9% |
| Site 2 | 18.0% (24/133) | 100%(24/24) (85.8%-100%) | 98.2% (107/109) (93.5% - 99.8%) | 98.5% |
| Site 3 | 9.1% (21/232) | 100%(21/21) (83.9%-100%) | 100.0% (211/211) (98.3% - 100.0%) | 100% |
| Site 4 | 16.8% (48/286) | 100% (48/48)(92.6%-100%) | 98.3% (234/238) (95.8% - 99.5%) | 98.6% |
| Site 5 | 2.3% (2/86) | 100%(2/2) (15.8%-100%) | 100.0% (84/84) (95.7% - 100.0%) | 100% |
1 Binomial 95% exact confidence intervals.
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Table 3. Performance obtained with BD GeneOhm™ StaphSR for S. aureus (by investigational site) in comparison to the reference method.
| Investiga<br>tional<br>site | S. aureus<br>prevalence | S. aureus Positive<br>% Agreement<br>(95% CI) , | S. aureus Negative<br>% Agreement<br>(95% CI) 1 | Overall<br>% Agreement |
|-----------------------------|-------------------------|-------------------------------------------------|-------------------------------------------------|------------------------|
| Site 1 | 22.2% (99/446) | 100.0% (99/99) (96.3%-100%) | 100% (347/347)(98.9%-100%) | 100% |
| Site 2 | 30.1% (40/133) | 100% (40/40)(91.2%-100%) | 98.9% (92/93) (94.2%-100%) | 99.2% |
| Site 3 | 35.8% (83/232) | 100% (83/83)( 95.7%-100%) | 100% (149/149) (97.6%-100%) | 100% |
| Site 4 | 29.7% (85/286) | 98.8% (84/85) (93.6% - 100.0%) | 96.5% (194/201) (93.0% - 98.6%) | 97.2% |
| Site 5 | 9.3% (8/86) | 100% (8/8) (63.1% - 100.0%) | 100% (78/78) (95.4%-100%) | 100% |
1 Binomial 95% exact confidence intervals.
### Table 4. Unresolved results
| Investigational<br>site | % Initial Unresolved with 95%<br>exact confidence intervals | % Repeat Unresolved with 95%<br>exact confidence intervals |
|-------------------------|-------------------------------------------------------------|------------------------------------------------------------|
| Site 1 | 0.0% (0/446)<br>(0.0% - 0.8%) | 0.0% (0/446)<br>(0.0% - 0.8%) |
| Site 2 | 0.0% (0/133)<br>(0.0% - 2.7%) | 0.0% (0/133)<br>(0.0% - 2.7%) |
| Site 3 | 0.0% (0/232)<br>(0.0% - 1.6%) | 0.0% (0/232)<br>(0.0% - 1.6%) |
| Site 4 | 0.3% (1/286)<br>(0.0% - 1.9%) | 0.0% (1/286)<br>(0.0% - 1.3%) |
| Site 5 | 0.0% (0/86)<br>(0.0% - 4.2%) | 0.0% (0/86)<br>(0.0% - 4.2%) |
### Table 5. Invalid assays
| Investigational<br>site | % Initial invalid runs with 95%<br>exact confidence intervals | % Invalid repeat runs with 95%<br>exact confidence intervals |
|-------------------------|---------------------------------------------------------------|--------------------------------------------------------------|
| Site 1 | 1.8% (2/113) (0.2% - 6.2%) | 0.0% (0/113) (0.0% - 3.2%) |
| Site 2 | 8.9% (5/56) (3.0% - 19.6%) | 0.0% (0/56) (0.0% - 6.4%) |
| Site 3 | 2.9% (2/69) (0.4% - 10.1%) | 0.0% (0/69) (0.0% - 5.2%) |
| Site 4 | 2.4% (2/84) (0.3% - 8.3%) | 0.0% (0/84) (0.0% - 4.3%) |
| Site 5 | 7.7% (5/65) (2.5% - 17.0%) | 0.0% (0/65) (0.0% - 5.5%) |
·
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its wings or feathers. The symbol is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
DEC 2 0 2007
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Raymond Boulé Senior Director, Regulatory Affairs BD Diagnostics (GeneOhm Sciences Canada, Inc.) 6146 Nancy Ridge Drive San Diego, CA 92121
K071026 Re: Trade/Device Name: BD GeneOhm™ StaphSR Assay Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: NQX Dated: November 23, 2007 Received: November 26, 2007
Dear Mr. Boulé:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, 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 subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (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 Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ' (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attaym
Sally A. Hojvat, M.Sc., Ph.D. 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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# Indications for Use Statement
K071026 510(k) Number (if known):
BD GeneOhm™ StaphSR Assay Device Name:
Indications For Use:
The BD GeneOhm™ StaphSR Assay is a qualitative in vitro diagnostic test for the rapid detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) directly from positive blood culture. The assay utilizes polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the real-time detection of the amplified DNA. The assay is performed on Gram positive cocci, identified by Gram stain, from positive blood cultures. The BD GeneOhm™ StaphSR Assay is not intended to monitor treatment for MRSA/SA infections. Subculturing of positive blood cultures is necessary for further susceptibility testing.
OR Prescription Use XXX
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices Evaluation and Safety (OIVD)
Freddie Poole
Division Sign-Off
vision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K071026
