← Product Code [LRT](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/LRT) · K951113 # CROSS-CHECKS (K951113) _Steritec Products Mfg Co, Inc. · LRT · Aug 19, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/LRT/K951113 ## Device Facts - **Applicant:** Steritec Products Mfg Co, Inc. - **Product Code:** [LRT](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/LRT.md) - **Decision Date:** Aug 19, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.2800 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use SteriTec CROSS-CHECKS sterilization chemical monitoring strips are designed to be utilized in steam sterilizers operating at 132°C to 135°C (270°F to 276°F). When used as directed, the SteriTec Cross-Checks indicator strips give visible indication that sterilizing conditions were met. During steam sterilization, the check mark at the end of the strip changes from white to black, becoming as dark or darker in intensity than the black reference arrow printed on the strip. ## Device Story Chemical indicator strip for steam sterilization monitoring; placed in steam sterilizer with load. Input: steam sterilization conditions (temperature/time). Transformation: chemical reaction causing color change from white to black. Output: visual color change compared to reference arrow. Used in clinical/hospital steam sterilizers; operated by healthcare staff (nurses/technicians). Provides immediate visual feedback on sterilization cycle success; aids in quality assurance of sterilized instruments; benefits patient by confirming sterilization parameters met. ## Clinical Evidence Bench testing only. Performance verified via independent laboratory testing comparing indicator strips to biological spore strips across various temperatures (124°C–134°C) and times (1–3.5 minutes). Results demonstrated color change to black only after biological spore strips showed no survivors. Storage stability tested under extreme temperature (57°C) and humidity (75%) conditions; strips maintained performance functionality. ## Technological Characteristics Chemical indicator strip; color-changing chemistry (white to black). Dimensions/form factor: strip. Connectivity: none. Sterilization method: N/A (device is an indicator). Software: none. ## 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 - ATI Division of PyMah Corporation Sterilometer Steam 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} FROM : SteriTec Prod. PHONE NO. : 303 660 4213 K951113 P12 p140 SteriTec Products Mfg. Co., Inc. CROSS-CHECKS Steam Sterilization Indicator Strip FDA 510(k) Application 510(k) SUMMARY # 510(k) PREMARKET NOTIFICATION SUMMARY ## SUBMITTER: - STERITEC PRODUCTS MFG. CO., INC. 680 Atchison Way - Suite 600 Castle Rock, CO 80104 (303) 660-4201 - Establishment Registration Number: 2028456 - Date: AUGUST 12, 1996 - **TOM ROLL** Printed name of person required to submit 510(k) [Handwritten signature] Signature of person required to submit 510(k) - **PRESIDENT** Title of person submitting 510(k) Proprietary Name: CROSS-CHECKS Steam Sterilization Indicator Strip Common/Usual Name: Steam Sterilization Indicator Classification Name: Physical/Chemical Sterilization Indicator Classification: Class II {1} FROM : SteriTec Prod. PHONE NO. : 303 660 4213 K95/113 P03 p.2q/10 SteriTec Products Mfg. Co., Inc. CROSS-CHECKS Chemical Sterilization Indicator FDA 510(k) Application Revised August 12, 1996 as requested by Reviewer PAGE - 2 510(k) SUMMARY Identification of Predicate devices: The SteriTec product is similar in design, composition and function to the: - ATI Division of PyMah Corporation Sterilometer Steam Strip® chemical indicator strip for steam The predicate product was marketed prior to May 28, 1976 Description of 510(k) submission device. Intended use: SteriTec CROSS-CHECKS sterilization chemical monitoring strips are designed to be utilized in steam sterilizers operating at 132°C to 135°C (270°F to 276°F). When used as directed, the SteriTec Cross-Checks indicator strips give visible indication that sterilizing conditions were met. During steam sterilization, the check mark at the end of the strip changes from white to black, becoming as dark or darker in intensity than the black reference arrow printed on the strip. Comparison to Predicate device: The basic formula and concept of black to white chemical steam sterilization indicators has not changed dramatically since they were invented in 1932. Laboratory testing Laboratory tests were performed to substantiate and verify that the performance of the submitted SteriTec product performed as described. These tests were performed by an independent testing laboratory. The following tests were performed. Test 1 - Completed Sterilization Cycle 3 Minutes @ 132°C (270°F) ATI and SteriTec sterilization indicator strips were placed in the center of a steam bier vessel along with a spore strip and sterilized at 132°C (270°F) for three minutes. Results: All indicator strips changed color to black, indicating proper functioning of the strips. The test spore strips from each run and the control spore strip were tested. All of the test spore strips showed a {2} FROM : SteriTec Prod. PHONE NO. : 303 660 4213 P04 K951113 p.3410 SteriTec Products Mfg. Co., Inc. CROSS-CHECKS Chemical Sterilization Indicator FDA 510(k) Application Revised August 12, 1996 as requested by Reviewer PAGE - 3 510(k) SUMMARY complete kill while the control strip showed all survivors. All indicator strips passed this test. Test 2 - Incomplete Sterilization Cycle 20 Seconds @ 132°C (270°F) ATI and SteriTec sterilization indicator strips were placed in the center of a steam bier vessel along with a spore strip and sterilized at 132°C (270°F) for only 20 seconds, to simulate improper sterilization conditions. Results: All indicator strips showed incomplete color change (none turned to black), indicating improper sterilization conditions and proper functioning of the strips. The test spore strips for each run and the control spore strip were tested. All of the test spore strips and the control strip showed all survivors. All indicator strips passed this test. Test 3 - Performance Data for Storage of Cross-Check Strips A. Cross-Checks Strips stored under normal conditions SteriTec CROSS-CHECKS sterilization indicator strips were stored for three (3) years and five (5) months at normal room temperatures 10°-38°C (50-100°F) and humidity Results: The strips were examined for correct indicator color (white). All strips appeared unchanged by the storage process. B. Cross-Checks Strips stored under normal conditions then sterilized. SteriTec CROSS-CHECKS sterilization indicator strips were stored for three (3) years and five (5) months at normal room temperatures 10°-38°C (50-100°F) and humidity. The indicator strips were placed in the center of a gravity steam sterilizer and sterilized at 121°C (250°F) for fifteen minutes. Results: All indicator strips changed color to black, indicating proper functioning of the strips and no change in their performance caused by normal storage. C. Cross-Checks Strips subjected to extreme temperature. SteriTec CROSS-CHECKS sterilization indicator strips were stored in a constant temperature chamber at 57°C (134°F) for eight (8) days. The temperature of 57°C (134°F) was selected since it would represent a higher temperature than any storage area in institutions where the strips would be stored. Results: Following storage the strips were removed and examined. The color of the strip had NOT changed from its original normal white color. {3} FROM : SteriTec Prod. PHONE NO. : 303 660 4213 P05 K95113 p.4 of 10 SteriTec Products Mfg. Co., Inc. CROSS-CHECKS Chemical Sterilization Indicator FDA 510(k) Application Revised August 12, 1996 as requested by Reviewer PAGE - 4 510(k) SUMMARY D. Cross-Checks Strips subjected to extreme temperature then sterilized. Cross-Check strips were stored in a constant temperature chamber at 57° C. (134° F.) for eight (8) days. Strips were placed in the center of a gravity steam sterilizer and sterilized at 121°C (250°F) for fifteen minutes. Results: Following the fifteen minute sterilization cycle, all test strips were removed and evaluated. All indicator strips changed color to black, indicating proper functioning of the strips and no change in their performance caused by storage in extreme heat conditions. E. Cross-Checks Strips subjected to extreme humidity. SteriTec CROSS-CHECKS sterilization indicator strips were stored in a vacuum desiccator (bell jar) along a saturated sodium chloride solution with the humidity controlled at 75%. The bell jar was then stored in a constant temperature chamber at normal room temperature of 20° C. (68° F.) for seven (7) days. Results: Following storage the strips were removed and examined. The color of the strip had NOT changed from its original normal white color. F. Cross-Checks Strips subjected to extreme humidity then sterilized. SteriTec CROSS-CHECKS sterilization indicator strips were stored in a vacuum desiccator (bell jar) along a saturated sodium chloride solution with the humidity controlled at 75%. The bell jar was then stored in a constant temperature chamber at normal room temperature of 20° C. (68° F.) for seven (7) days. The indicator strips were placed in the center of a gravity steam sterilizer and sterilized at 121°C (250°F) for fifteen minutes. Results: Following the fifteen minute sterilization cycle, all test strips were removed and evaluated. All indicator strips changed color to black, indicating proper functioning of the strips and no change in their performance caused by storage in extreme humidity conditions. G. Cross-Checks Strips subjected to extreme temperature and humidity. SteriTec Cross-Check sterilization indicator strips were stored in a vacuum desiccator (bell jar) along a saturated sodium chloride solution with the humidity controlled at 75%. The bell jar was then placed in a constant temperature chamber at 57° C. (134° F.) for eight (8) days. The temperature of 57° C. (134° F.) was selected since it would represent a higher temperature than any storage area in institutions where the strips would be stored. Results: Following storage the strips were removed and examined. The {4} FROM : SteriTec Prod. PHONE NO. 303 660 4213 P06 K95/113 p.5q18 SteriTec Products Mfg. Co., Inc. CROSS-CHECKS Chemical Sterilization Indicator FDA 510(k) Application Revised August 12, 1996 as requested by Reviewer PAGE - 5 510(k) SUMMARY color of the strip had changed from its original white color to a light tan. H. Cross-Checks Strips subjected to extreme temperature and humidity then sterilized. SteriTec Cross-Check sterilization indicator strips were stored in a vacuum desiccator (bell jar) along a saturated sodium chloride solution with the humidity controlled at 75%. The bell jar was then placed in a constant temperature chamber at 57° C. (134° F.) for eight (8) days. Results: Following the fifteen minute sterilization cycle, the test strips were removed and evaluated. All indicator strips changed color to black, indicating proper functioning of the strips and no change in their performance caused by storage in extreme heat and humidity conditions. Test 4 - Performance Data for Cross-Checks Strips sterilized at various sterilization temperatures and sterilization times. (1) SteriTec Cross-Checks sterilization indicator strips catalog numbers CI 102 and CI 111 were subjected to a steam sterilization cycles for 3 minutes at the following sterilization temperatures: 124°C 128°C 130°C 132°C 134°C Approximately 300 strips along with 12 biological spore strips were run at each temperature range. (2) SteriTec sterilization indicator strips catalog numbers CI 102 and CI 111 were subjected to a steam sterilization cycles at 132°C for the following times: 1 min 2 min 2½ min 3 min 3½ min Approximately 300 strips along with 12 biological spore strips were run at each temperature range. ## Interpretation of Results: To make the interpretation as objective as possible a panel of three people selected by the independent laboratory were used to make the PASS/FAIL determinations. These results are shown in Tables 1 and 2. Since a few of the results from the first set of interpreters were considered outside the product specifications another set of three interpreters were hired by Steritec to again make the interpretations of the same indicators described in (1) and (2) above. These interpreters were all nurses who generally have more experience in chemical indicator interpretations. These results are shown in Tables 3 and 4. ## Conclusion: Results of performance testing of the SteriTec Cross-Checks Indicator Strips indicate that the submitted product, SteriTec Cross-Checks, performed as {5} FROM : SteriTec Prod. PHONE N1. : 303 660 4213 K951113 P02 P4810 SteriTec Products Mfg. Co., Inc. CROSS-CHECKS Chemical Sterilization Indicator FDA 510(k) Application Revised August 12, 1996 as requested by Reviewer PAGE - 6 510(k) SUMMARY specified and in all cases completed a color change only after the biological spore strips tested at the same time under the same conditions, had expired. The interpretations of the second set of interpreters (Nurses) were more uniform in their determinations of whether or not the indicators passed or failed. {6} K95113 0.7d10 SteriTec Products Mfg. Co., Inc. CROSS-CHECKS Chemical Sterilization Indicator FDA 510(k) Application Revised August 12, 1996 as requested by Reviewer PAGE - 7 510(k) SUMMARY TABLE 1 | Additional Performance Testing-Cross-Checks CI 102 | | | | | | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 3 Minutes Sterilization Time at: | | | | | | | | | | | | | | | | 124°C | | | 128°C | | | 130°C | | | 132°C | | | 134°C | | | | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | | 0 | 275 | 12/12 | 0 | 300 | 1/12 | 108 | 183 | 0/12 | 342 | 92 | 0/12 | 292 | 0 | 0/12 | | | | | | | | | | | | | | | | | | 132°C for: | | | | | | | | | | | | | | | | 1 minute | | | 2 minutes | | | 2½ minutes | | | 3 minutes | | | 3½ minutes | | | | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | | 0 | 292 | 9/12 | 17 | 275 | 0/12 | 142 | 150 | 0/12 | 342 | 92 | 0/12 | 292 | 0 | 0/12 | TABLE 1 Notes: Pos=Positive result (PASS) Neg=Negative result (FAIL) Bio=Biological spore strips. + = Survivors - = No Survivors {7} SterTec Products Mfg. Co., Inc. CROSS-CHECKS Chemical Sterilization Indicator FDA 510(k) Application Revised August 12, 1996 as requested by Reviewer PAGE - 8 510(k) SUMMARY TABLE 2 | Additional Performance Testing - Cross-Checks C1 111 | | | | | | | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 3 Minutes Sterilization Time at: | | | | | | | | | | | | | | | | | 124°C | | | 128°C | | | 130°C | | | 132°C | | | 134°C | | | | | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | | | 0 | 300 | 12/12 | 0 | 292 | 1/12 | 75 | 225 | 0/12 | 233 | 217 | 0/12 | 292 | 0 | 0/12 | | | | | | | | | | | | | | | | | | | | 132°C for: | | | | | | | | | | | | | | | | | 1 minute | | | 2 minutes | | | 2½ minutes | | | 3 minutes | | | 3½ minutes | | | | | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | | | 0 | 300 | 9/12 | 0 | 283 | 0/12 | 108 | 192 | 0/12 | 233 | 217 | 0/12 | 300 | 0 | 0/12 | | TABLE 2 Notes: Pos=Positive result (PASS) Neg=Negative result (FAIL) Bio=Biological spore strips. + = Survivors - = No Survivors {8} SteriTec Products Mfg. Co., Inc. CROSS-CHECKS Chemical Sterilization Indicator FDA 510(k) Application Revised August 12, 1996 as requested by Reviewer PAGE - 9 510(k) SUMMARY TABLE 3 | Additional PerformanceTesting - Cross-Checks CI 102(Nurse Interpreters) | | | | | | | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 3 Minutes Sterilization Time at: | | | | | | | | | | | | | | | | | 124°C | | | 128°C | | | 130°C | | | 132°C | | | 134°C | | | | | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | | | 0 | 275 | 12/12 | 0 | 300 | 1/12 | 92 | 200 | 0/12 | 400 | 50 | 0/12 | 300 | 0 | 0/12 | | | | | | | | | | | | | | | | | | | | 132°C for: | | | | | | | | | | | | | | | | | 1 minute | | | 2 minutes | | | 2½ minutes | | | 3 minutes | | | 3½ minutes | | | | | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | | | 0 | 300 | 9/12 | 0 | 300 | 0/12 | 133 | 167 | 0/12 | 400 | 50 | 0/12 | 300 | 0 | 0/12 | | TABLE 3 Notes: Pos=Positive result (PASS) Neg=Negative result (FAIL) Bio=Biological spore strips. + = Survivors - = No Survivors {9} K951113 p. 10 of 10 SteriTec Products Mfg. Co., Inc. CROSS-CHECKS Chemical Sterilization Indicator FDA 510(k) Application Revised August 12, 1996 as requested by Reviewer PAGE 10 510(k) SUMMARY TABLE 4 | Additional PerformanceTesting -Cross-Checks CI 111(Nurse Interpreters) | | | | | | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 3 Minutes Sterilization Time at: | | | | | | | | | | | | | | | | 124°C | | | 128°C | | | 130°C | | | 132°C | | | 134°C | | | | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | | 0 | 275 | 12/12 | 0 | 292 | 1/12 | 50 | 250 | 0/12 | 458 | 8 | 0/12 | 300 | 0 | 0/12 | | | | | | | | | | | | | | | | | | 132°C for: | | | | | | | | | | | | | | | | 1 minute | | | 2 minutes | | | 2½ minutes | | | 3 minutes | | | 3½ minutes | | | | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | Pos | Neg | Bio +/- | | 0 | 275 | 9/12 | 0 | 283 | 0/12 | 142 | 150 | 0/12 | 458 | 8 | 0/12 | 292 | 0 | 0/12 | TABLE 4 Notes: Pos=Positive result (PASS) Neg=Negative result (FAIL) Bio=Biological spore strips. + = Survivors - = No Survivors --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/LRT/K951113](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/LRT/K951113) **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