← Product Code [FRC](/productcode/FRC) · K024079 # ALIBI BIOLOGICAL INDICATOR, MODEL WS (K024079) _Arden Laboratories, Incorporated · FRC · Feb 27, 2003 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K024079 ## Device Facts - **Applicant:** Arden Laboratories, Incorporated - **Product Code:** [FRC](/productcode/FRC.md) - **Decision Date:** Feb 27, 2003 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 880.2800 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use The ALIBI biological indicator is used to monitor the efficacy of ethylene oxide sterilization cycles. ## Device Story ALIBI Biological Indicator monitors ethylene oxide (EO) sterilization efficacy. Device consists of paper carrier inoculated with Bacillus subtilis var. niger ATCC 9372 endospores, enclosed in glassine primary packaging. Following EO cycle exposure, indicator is incubated in soybean casein digest broth at 30-35°C for 7 days. Growth, indicated by turbidity in medium, signifies sterilization failure; clear medium indicates successful spore kill. Used by healthcare personnel to verify sterilization process performance. ## Clinical Evidence Bench testing only. Stability studies evaluated population, purity, D-value, survival time, and kill time per USP XXV methods. Real-time data through 12 months confirms performance within USP XXV acceptance criteria. ## Technological Characteristics Biological indicator consisting of paper carrier inoculated with Bacillus subtilis var. niger ATCC 9372 endospores; primary packaging is glassine. Complies with USP XXV:2002 monograph for Biological Indicator for Ethylene Oxide Sterilization. ## Regulatory Identification Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device. ## Predicate Devices - Raven Bacterial Spore Strip ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Arden Laboratories Incorporated. The text is in a bold, sans-serif font. The words "Arden Laboratories" are stacked on top of each other, and the word "Incorporated" is centered below them. The logo is black and white. FEB 2 7 2003 SUSAN L. JOHNSON Chief Executive Officer susan@ardenlabs.com K024079 ANGELA STRANTZ, Ph.D. Chief Technical Officer angela@ardenlabs.com ## 510(k) Summary | Submitted by: | Arden Laboratories, Inc.
468B Stillwater Road
P.O. Box 486
Willernie, Minnesota 55090-0468 | | |-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------| | | Telephone
Fax
E-mail | 651-762-9224
651-762-9226
angela@ardenlabs.com | | Contact: | Angela Strantz, PhD
Chief Technical Officer | | | Prepared on: | December 6, 2002 | | | Trade Name: | ALIBI Biological Indicator | | | Common Name: | Biological Indicator for Ethylene Oxide, Paper
Carrier | | | Classification: | II | | | Predicate Device: | Raven Bacterial Spore Strip
Pre-amendment device | | | Description: | ALIBI is a biological indicator that complies with the
USP XXV:2002 monograph Biological Indicator for
Ethylene Oxide Sterilization, Paper Carrier. The
ALIBI biological indicator consists of a paper carrier
inoculated with of Bacillus subtilis var. niger ATCC
9372 bacterial endospores, and a primary package
made of glassine. | | | | After exposure to an ethylene oxide sterilization
cycle, the biological indicator is incubated in | | soybean casein digest broth at 30-35°C for 7 days. {1}------------------------------------------------ | Description (continues): | Growth of biological indicator spores is evidenced
by the presence of turbidity in the growth medium.
If the sterilization cycle killed all of the biological
indicator spores, the growth medium remains clear. | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use: | The ALIBI biological indicator is used to monitor the
efficacy of ethylene oxide sterilization cycles. | | Statement of Similarity: | Equivalence of the ALIBI biological indicator is
demonstrated through compliance to the
recognized standard, USP XXV:2002 monograph
Biological Indicator for Ethylene Oxide Sterilization ,
Paper Carrier. | | Description of Testing | Stability studies on three lots manufactured from
three different spore crops are in progress. Each lot
is evaluated for population, purity, DEO-value,
survival time and kill time. The methods described
in USP XXV were used, except for the population
test. Here a validated, alternative method is used. | | | Real time data through the 12 months test interval
shows that population, purity, and resistance
values remain within the acceptance criteria in USP
XXV. | | Conclusion: | The ALIBI biological indicator is appropriate for
monitoring the efficacy of ethylene oxide
sterilization cycles. | : . {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## FEB 2 7 2003 Dr. Angela Strantz Chief Technical Officer Arden Laboratories, Incorporated 468B Stillwater Road Willernie, Minnesota 55090 Re: K024079 Trade/Device Name: The ALIBI Biological Indicator Regulation Number: 880.2800 (a) Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: December 6, 2002 Received: December 10, 2002 Dear Dr. Strantz: 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ Page 2 - Dr. Strantz 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 Compliance at (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Susan Runirer Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use Statement Page 1 510(k) Number (if known): Device Name: ALIBI Biological Indicator Indications for Use: The ALIBI biological indicator is used to monitor the efficacy of ethylene oxide sterilization cycles. (PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Olin S. Lin (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices r 024079 510(k) Number.***_***_ --- **Source:** [https://fda-staging.innolitics.com/device/K024079](https://fda-staging.innolitics.com/device/K024079) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com