← Product Code [GLK](/submissions/HE/subpart-i%E2%80%94hematology-reagents/GLK) · K961807 # CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 (K961807) _Ciba Corning Diagnostics Corp. · GLK · Jul 26, 1996 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-i%E2%80%94hematology-reagents/GLK/K961807 ## Device Facts - **Applicant:** Ciba Corning Diagnostics Corp. - **Product Code:** [GLK](/submissions/HE/subpart-i%E2%80%94hematology-reagents/GLK.md) - **Decision Date:** Jul 26, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.8625 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use The intended use Certain® Hct is as a bi-level quality control material and CVM™ is a calibration verification material both for use with hematocrit analyzers. ## Device Story Certain® Hct and CVM™ Hct function as quality control and calibration verification materials for hematocrit analyzers; bi-level formulation for quality control; four-level formulation for calibration verification; provided in 2.5 mL ampules; used by laboratory personnel to verify analyzer performance and ensure compliance with CLIA calibration verification requirements; aqueous-based solutions containing bicarbonate and salts; provides reference values for comparison against analyzer output; assists in maintaining diagnostic accuracy of hematocrit measurements. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics Assayed aqueous-based solution containing bicarbonate and other salts. Formulated as bi-level (Certain® Hct) and four-level (CVM™ Hct) materials. Supplied in 2.5 mL ampules. ## Regulatory Identification A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC). ## Special Controls *Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. ## Predicate Devices - GEM critCheck (Manufacturer: Mallinckrodt) ## 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} K961807 JUL 26 1996 # Summary of Safety and Effectiveness As required by 21 CFR 807.92, the following 510(k) Summary is provided: ## 1. Submitters Information Contact person: William J. Pignato Director of Regulatory Affairs Address: Chiron Diagnostics Corp. 63 North Street Medfield, MA 02052 Phone: 508 359-3825 Date Summary Prepared: April 25, 1996 ## 2. Device Information Proprietary Name: Certain® Hct and CVM™ Hct Common Name: Hematocrit quality control and calibration verification materials Classification Name: Quality Control Material (assayed & unassayed Calibration Verification Material Classification Number: 21 CFR 862.1660 ## 3. Predicate Device Information Name: GEM critCheck Manufacturer: Mallinckrodt 510(k) Number: ## 4. Device Description The Chiron Certain Hct is a bi-level quality control material uniquely formulated to provide quality control values for hematocrit analyzers. There are two levels of Certain Hct each provided in 2.5 mL ampules. The product allows verification of analyzer hematocrit performance within established ranges. Chiron Calibration Vefication Material (CVM™) is formulated to verify the calibration of hematocrit analyzers. The product contains four levels of 2.5 mL ampules and is intended to assist laboratories in compliance with the requirements of calibration verification under CLIA. Certain® HCT 510(k) Application {1} 5. Statement of Intended Use The intended use Certain® Hct is as a bi-level quality control material and CVM™ is a calibration verification material both for use with hematocrit analyzers. 6. Summary of Technological Characteristics Certain® Hct and CVM™ Hct are assayed aqueous based bicarbonate solution and other salts. Certain® HCT 510k) Application --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-i%E2%80%94hematology-reagents/GLK/K961807](https://fda.innolitics.com/submissions/CH/subpart-i%E2%80%94hematology-reagents/GLK/K961807) **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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