SPECTRA MRSA

K073027 · Thermo Fisher Scientific · JSO · Feb 28, 2008 · Microbiology

Device Facts

• Record ID: K073027
• Device Name: SPECTRA MRSA
• Applicant: Thermo Fisher Scientific
• Product Code: JSO · Microbiology
• Decision Date: Feb 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1700
• Device Class: Class 2

Intended Use

Remel Spectra™ MRSA is a selective and differential chromogenic medium recommended for use in the qualitative detection of nasal colonization of methicillin-resistant Staphylococcocus aureus (MRSA) to aid in the prevention and control of MRSA in healthcare settings. The test is performed with anterior nares swab specimens from patients and healthcare workers to screen for MRSA colonization. Spectra™ MRSA is not intended to diagnose MRSA infection or to quide or monitor treatment for infections.

Device Story

Spectra™ MRSA is a selective/differential chromogenic culture medium for screening nasal MRSA colonization. Input: anterior nares swab specimens. Principle: medium contains antibacterial compounds to inhibit competitor organisms and compounds to induce MRSA phosphatase activity; phosphatase reacts with a novel chromogen to produce denim-blue colonies. Used in healthcare settings by laboratory personnel. Output: visual identification of denim-blue colonies after 24-hour incubation. Healthcare providers use presence of blue colonies to identify MRSA-colonized individuals, facilitating infection control measures. Benefits: rapid screening (24 hours) to support MRSA prevention programs.

Clinical Evidence

Prospective clinical study of 767 anterior nare specimens across four U.S. regions. Spectra™ MRSA (24h incubation) compared to traditional culture (48h) and susceptibility testing. Sensitivity 95.4% (95% CI 89.6–98.5%), specificity 99.7% (95% CI 98.9–100%), overall agreement 99.1% (95% CI 98.1–99.6%). Positive predictive value 98.1%, negative predictive value 99.2%. Interfering substances (medicinal, transport media, blood, mucous) showed no interference. Reproducibility tested with 20 blinded S. aureus strains.

Technological Characteristics

Selective/differential chromogenic culture medium. Contains antibiotics/inhibitory agents for non-target organism suppression and chromogenic substrate for phosphatase detection. Form factor: prepared culture medium. Manual reading. No electronic components, software, or energy sources.

Indications for Use

Indicated for qualitative detection of nasal MRSA colonization in patients and healthcare workers via anterior nares swab specimens to aid in MRSA prevention and control. Not for diagnosing MRSA infection or guiding/monitoring treatment.

Regulatory Classification

Identification

A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.

Submission Summary (Full Text)

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K073027

# 510(k) CLINICAL TRIAL SUMMARY

# 11 28

Spectra™ MRSA Device Trade Name:

Remel Spectra™ MRSA is a selective and differential chromogenic Intended Use: medium recommended for use in the qualitative detection of nasal colonization of methicillin-resistant Staphylococcocus aureus (MRSA) to aid in the prevention and control of MRSA in healthcare settings. The test is performed with anterior nares swab specimens from patients and healthcare workers to screen for MRSA colonization. Spectra™ MRSA is not intended to diagnose MRSA infection or to quide or monitor treatment for infections.

- Remel Spectra™ MRSA is an opaque medium, which uses a novel Device Description: chromogen that yields a denim-blue color as a result of phosphatase activity. This enzyme is present in all MRSA. To allow the medium to differentiate MRSA accurately, it contains a combination of antibacterial compounds designed to inhibit the growth of a wide variety of competitor organisms. Also included are compounds that encourage the production of MRSA pathogenicity marker, ensuring expression of the phosphatase enzyme and so providing enhanced sensitivity and specificity.
#### Summary of Performance Data:

#### Clinical Accuracy:

The performance of Spectra™ MRSA was evaluated at four geographically diverse regions of the United States. A total of seven hundred sixty-seven (767) prospective anterior nare surveillance specimens were tested. Results from the Spectra™ MRSA at 24 hours incubation were compared to results obtained from traditional culture on Tryptic Sov Agar with 5% Sheep Blood Agar) after 48 hours incubation. During the course of this study, one swab was used to inoculate both plates, with the Blood Agar plate being inoculated first for all specimens. The overall recovery of MRSA on Spectra™ MRSA at 24 hours was 95.4% (104/109) compared to recovery of 96.3% (105/109) on Blood Agar at 48 hours.

Suspect isolates of S. aureus were identified using a latex agglutination test or a biochemical identification system. Susceptibility testing was performed using an antibiotic gradient method for oxacillin and the Oxoid PBP2' test for the detection of the penicillin-binding protein 2a. The overall agreement for detection of MRSA and non-MRSA by denim blue colonies isolated on Spectra™ MRSA at 24 hours compared to identification and susceptibility testing as described was 99.1% (760/767). The positive and negative predictive values for Spectra™ MRSA compared to the Oxoid PBP2' test were 98.1% and 99.2% respectively.

| | Traditional Culture | | |
|------------------|---------------------|-----|-----|
| | + | - | |
| Spectra™<br>MRSA | + | 100 | 6* |
| | - | 5 | 656 |
| TOTAL | | 105 | 662 |

% Agreement MRSA: 95.2% (95% CI = 89.2–98.4%) Non-MRSA: 99.1% (95% CI = 98.0-99.7%) Overall: 98.6% (95% Cl = 97.5-99.3%)

*Four MRSA positive specimens were negative by traditional culture at 48 hours. Note : CI = Confidence Interval

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| | | Oxacillin MIC | |
|------------------|---|---------------|-----|
| | | + | - |
| Spectra™<br>MRSA | + | 104 | 2 |
| | - | 5 | 656 |
| TOTAL | | 109 | 658 |

| | | PBP2' | |
|-----------|---|-------|-----|
| | | + | - |
| SpectraTM | + | 104 | 2 |
| MRSA | - | 5 | 656 |
| TOTAL | | 109 | 658 |

% Aareement MRSA: 95.4% (95% Cl = 89.6-98.5%) Non-MRSA: 99.7% (95% CI = 98.9-100%) Overall: 99.1% (95% CI = 98.1-99.6%)

Sensitivity: 95.4% (95% CI = 89.6-98.5%) Specificity: 99.7% (95% CI = 98.9-100%) Agreement: 99.1% (95% CI = 98.1-99.6%) Positive Predictive Value: 98.1% (95% Cl = 93.4-99.8%) Negative Predictive Value: 99.2% (95% Cl = 98.2–99.8%)

# Overall Agreement:

| | MRSA | Non-MRSA |
|---------------------------------------|---------------------------------------------|--------------------------------------------|
| Spectra™ MRSA vs. traditional culture | 95.2%<br>(100/105)<br>(95% CI = 89.6–98.5%) | 99.1%<br>(656/662)<br>(95% CI = 98.9–100%) |
| Spectra™ MRSA vs. PBP2' | 95.4%<br>(104/109)<br>(95% CI = 89.6-98.5%) | 99.7%<br>(656/658)<br>(95% CI = 98.9-100%) |
| Spectra™ MRSA vs. Oxacillin MIC | 95.4%<br>(104/109)<br>(95% CI = 89.6-98.5%) | 99.7%<br>(656/658)<br>(95% CI = 98.9-100%) |

*Four MRSA positive specimens were negative by traditional culture at 48 hours.

# Performance Compared to Commercially Available Devices:

Spectra™ MRSA was compared to traditional culture and susceptibility testing and the BD BBL™ CHROMagar™ MRSA with a total of 273 prospective nasal surveillance specimens. One swab was used to inoculate Blood Agar first and Spectra™ MRSA second. The second swab was used to inoculate the BD BBL™ CHROMagar™ MRSA. There was 98.9% agreement with traditional culture and susceptibility testing, and 97,1% agreement with the BD BBL™ CHROMagar™ MRSA. In this study, two nasal swabs were collected per patient.

#### Interfering Substances:

Commonly used medicinal substances and transport media, as well as human blood and mucous were evaluated for potential interference of the chromogenic reaction of Spectra™ MRSA. No interference was observed.

# Reproducibility:

Reproducibility testing was conducted at four sites on three separate days with twenty blinded strains of Staphylococcus aureus. The strains consisted of 12 MRSA, 1 BORSA. MRSA and MSSA strains produced the expected result with Spectra™ MRSA 100% of the time at 24 hours. BORSA demonstrated variable results.

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Public Health Service

FEB 28 2008

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mary Ann Silvius Director Clinical Marketing Remel Products Thermo Fisher Scientific 12076 Santa Fe Drive Lenexa, KS 66215

> k073027 Trade/Device Name: Remel Spectra™ MRSA Regulation Number: 21 CFR 866.1700 Regulation Name: Culture media, Antimicrobial susceptibility test, excluding Mueller Hinton Agar Regulatory Class: Class II Product Code: JSO Dated: January 28, 2008 Received: January 30, 2008

Dear Ms. Silvius:

Re:

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 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sally a. Hogg

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

#### 510(k) Number (if known): K073027

# Device Name: Spectra™ MRSA

Indications For Use: Remel Spectra™ MRSA is a selective and differential chromogenic medium recommended for use in the qualitative detection of nasal colonization of methicillin-resistant Staphylococcocus aureus (MRSA) to aid in the prevention and control of MRSA in healthcare settings. The test is performed with anterior nares swab specimens from patients and healthcare workers to screen for MRSA colonization. Spectra™ MRSA is not intended to diagnose MRSA infection or to guide or monitor treatment for infections.

Prescription Use_ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Freddie h. Poole
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K073027