← Product Code [JJX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX) · K971014 # LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS (K971014) _Lifescan, Inc. · JJX · Apr 23, 1997 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K971014 ## Device Facts - **Applicant:** Lifescan, Inc. - **Product Code:** [JJX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX.md) - **Decision Date:** Apr 23, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1660 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for Use SureStep®Pro Glucose Control Solutions are for use with SureStep® Brand Blood Glucose Meters and SureStep®Pro Test Strips as a quality control material for verification of System performance. The SureStep®Pro Linearity Test Kit is for use with SureStep® Brand Glucose Meters and SureStep®Pro Test Strips for verification of System linearity. ## Device Story SureStep®Pro Glucose Control and Linearity Test Solutions; aqueous glucose-based solutions; used with SureStep® blood glucose meters and test strips. Control solutions verify system performance by comparing meter results against expected ranges printed on test strip bottles. Linearity test solutions verify system linearity across measurement range. Used in clinical or home settings by patients or healthcare providers. Output provides qualitative/quantitative verification of system accuracy; failure to fall within expected ranges indicates system malfunction. Benefits patient by ensuring reliable glucose monitoring results. ## Clinical Evidence Bench testing only. Performance verified by comparing meter results using control/linearity solutions against established expected ranges to confirm system accuracy and linearity. ## Technological Characteristics Aqueous glucose-based solutions; formulated to provide specific glucose concentrations for system verification. Compatible with SureStep® brand meters and test strips. No electronic components, software, or connectivity. ## Regulatory Identification A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls. ## Predicate Devices - LifeScan SureStep® Glucose (Normal) Control Solution - Streck Laboratories Sugar-Chex® Linearity kit ## 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} SureStep®Pro Glucose Control /Linearity Solutions 510(k) Notification K971014 APR 23 1997 # 510(k) Summary ## Summary of Safety and Effectiveness | Submitter | LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035 Judy Martin, RAC | | --- | --- | | Date | March 18, 1997 | | Proprietary Name | LifeScan SureStep®Pro Glucose Control Solutions (Low, Normal and High) | | | LifeScan SureStep®Pro Linearity Test Kit | | Common Name | Single (specified) Analyte Control (Assayed) | | Classification Name | 21 CFR 862.1660, Quality Control Material (assayed and unassayed) - (75JJX) | ## Device Description The SureStep®Pro Glucose Control and Linearity Test Solutions are designed for use with LifeScan SureStep® Brand Blood Glucose Meters and SureStep®Pro Brand Test Strips. SureStep®Pro Glucose Control Solutions contain a measured amount of glucose that reacts with the SureStep®Pro Test Strips. When using the same procedure as testing with whole blood, the control solution should provide results within the expected SureStep®Pro Glucose Control Solution range printed on the test strip bottle. Obtaining results outside the expected range indicates the System is not performing correctly. The SureStep®Pro Linearity Test Solutions contain a measured amount of glucose. When the linearity solution is applied to a SureStep®Pro Test Strip in the same manner as the glucose controls the results are used to verify System linearity. LifeScan, Inc. CONFIDENTIAL Page 15 015 {1} SureStep®Pro Glucose Control /Linearity Solutions 510(k) Notification # Intended Use The intended use of the LifeScan SureStep®Pro Glucose Control Solutions and the currently marketed SureStep® Glucose (Normal) Control Solution is identical. The intended use for the SureStep®Pro Glucose Control Solutions is as follows: SureStep®Pro Glucose Control Solutions are for use with SureStep® Brand Blood Glucose Meters and SureStep®Pro Test Strips as a quality control material for verification of System performance. The intended use of the LifeScan SureStep®Pro Linearity Test Kit is equivalent to the Streck Sugar-Chex® Linearity kit with the exception that the SureStep®Pro Linearity Test Kit is not intended for calibration assessment. The intended use for the SureStep®Pro Linearity Test Kit is as follows: The SureStep®Pro Linearity Test Kit is for use with SureStep® Brand Glucose Meters and SureStep®Pro Test Strips for verification of System linearity. # Substantial Equivalence The LifeScan SureStep®Pro Glucose Control Solutions (Low, Normal and High) and Linearity Test Kit are substantially equivalent to the currently marketed LifeScan SureStep® Glucose (Normal) Control Solution and Streck Laboratories Sugar-Chex® Linearity kit, respectively. LifeScan, Inc. CONFIDENTIAL Page 16 016 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K971014](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K971014) **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. 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