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510(k) Data Aggregation
(273 days)
OC-Light S FIT
OC-Light S FIT (Fecal Immunochemical Test, also known as iFOBT, immunochemical fecal occult blood test) is a qualitative test intended for the immunochemical detection of fecal occult blood (FOB) by professional laboratories and physician office laboratories. Measurement of FOB is useful as an aid to detect blood in stool when gastrointestinal (GI) bleeding may be suspected. OC-Light S FIT is recommended for use in routine physical examinations.
OC-Light S FIT is an in vitro diagnostic device, a qualitative test designed for the immunochemical detection of human hemoglobin (hHb) in stool specimens. OC-Light S FIT consists of a test strip, and a sampling bottle containing buffer solution. OC-Light S FIT test strip consists of a nitrocellulose membrane with immobilized mouse monoclonal antibodies specific to human hemoglobin at the test region and immobilized rabbit anti-mouse antibodies at the control region, a sample pad, a conjugate pad which contains human hemoglobin specific mouse monoclonal antibodies conjugated with colloidal gold, an absorption pad, and a plastic backing. OC-Light S FIT sampling bottle is a plastic bottle for collecting fecal sample containing 2.0 mL of extraction buffer. When the sample end of the test strip is dipped in the fecal extract, the liquid fecal extract wicks through a series of absorbent materials and contacts colloidal gold conjugated with monoclonal antibodies specific to hHb. If hHb is present in the sample, it reacts with the antibodies on the colloidal gold. When the gold conjugate with hHb reaches the test region of the membrane, it binds with the immobilized antibodies also specific to hHb to form a visible reddish/pink line. The procedural control region of the membrane contains immobilized anti-mouse antibodies that capture the conjugate independent of the presence of the hHb, thereby always producing a distinct reddish/pink line. The reddish/pink line in the procedural control region demonstrates the validity of the test, and assures the operator that the device is working properly.
Here's an analysis of the acceptance criteria and study details for the OC-Light S FIT device based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold but rather presents performance data and concludes substantial equivalence based on comparisons. For this table, I'll extract the key performance metrics and the overall conclusion of substantial equivalence to the predicate device.
| Performance Metric | Acceptance Criteria (Implied by Comparison) | Reported Device Performance (OC-Light S FIT) |
|---|---|---|
| Cut-off Value | No significant difference from predicate (10 µg Hb/g stool or 50 ng/mL buffer) | Established at 10 µg Hb/g stool (50 ng/mL buffer). 100.0% positive at this cut-off. Overall agreement with expected results: 99.3% (95% CI 96.2 ~ 100.0%). |
| Reaction Time | Timely and accurate detection (e.g., 50 ng/mL positive at 5 minutes) | 50 ng/mL was 100% positive at 5 minutes. |
| Repeatability | High agreement with expected results, no invalid/indeterminate results | Overall Agreement: 99.3% (96.2% - 100.0%), Positive Agreement: 100.0% (96.2% - 100.0%), Negative Agreement: 98.1% (89.5% - 100.0%) |
| Reproducibility (Lot-to-Lot) | High agreement with expected results | Overall Agreement: 98.6% (Positive: 100.0%, Negative: 96.2%) |
| Reproducibility (Between-run) | High agreement with expected results | Overall Agreement: 99.8% (Positive: 99.6%, Negative: 100.0%) |
| Reproducibility (Between Device) | High agreement with expected results | Overall Agreement: 98.6% (Positive: 100.0%, Negative: 96.2%) |
| Reproducibility (Between-site) | High agreement with expected results | Overall Agreement: 98.4% (Positive: 99.6%, Negative: 96.2%) |
| Reproducibility (Combined) | High agreement with expected results | Overall Agreement: 98.9% (Positive: 99.8%, Negative: 97.1%) |
| Test Kit Stability (Accelerated) | Overall agreement > 90% | All tests showed overall agreement > 90%. Estimated stability: 19 months at 30°C. Claimed: 18 months at 30°C. |
| Sample Stability | Overall agreement > 90% for various temperatures/durations | All tests showed overall agreement > 90%. Stable for 30 days at 2-8°C, and 15 days at room temperature. |
| Test Kit Shipping Stress Test | Overall agreement > 90% | All tests showed overall agreement > 90%. Stable for 3 days at 45°C, and 3 freeze/thaw cycles. |
| Sample Shipping Stress Test | Overall agreement > 90% | All tests showed overall agreement > 90%. Stable for 3 days at 45°C, and 3 freeze/thaw cycles. |
| Hemoglobin Variants Detection | Equivalent detection of HbA0, HbS, HbC | Equivalently detected HbA0, HbS, and HbC. |
| Cross-Reactivity (Non-human Hb/Meat) | No interference | Not interfered by bovine, equine, goat, porcine, sheep, turkey, fish, rabbit Hb, or various meat extracts. |
| Interference (Dietary Substances) | No interference | Not interfered by broccoli, cantaloupe, cauliflower, horseradish, parsnip, red radish, turnip extracts, ascorbic acid, or iron. |
| Interference (Toilet Cleaners) | No interference | Not interfered by various toilet cleaners. |
| Prozone Effect | No prozone effect at elevated Hb levels | No prozone effect observed up to 400 µg/g stool (2000 ng/mL buffer). |
| Method Comparison (vs. Predicate) | Substantially equivalent performance to Polymedco OC Light FOB Test | Overall Agreement: 99.9% (95% CI: 99.4 ~ 100.0%). Positive Agreement: 100.0% (95% CI: 97.0 ~ 100.0%). Negative Agreement: 99.9% (95% CI: 99.3 ~ 100.0%). |
2. Sample Size Used for the Test Set and Data Provenance
The document describes several "test sets" for different studies:
- Cut-off Study: 147 samples (7 Hb concentrations x 21 replicates). Data provenance: In-house, spiked Hb-free stool specimens.
- Reaction Time Study: 147 samples (7 Hb concentrations x 21 replicates). Data provenance: In-house, spiked Hb-free stool specimens.
- Precision/Reproducibility Study: 147 samples (7 Hb concentrations x 21 replicates) per site, across three POL sites. Total for combined reproducibility: 1764 samples. Data provenance: Spiked Hb-free stool specimens shipped to US clinical coordinator for distribution to POL sites.
- Test Kit Stability (Accelerated): 441 samples per condition (7 Hb concentrations x 21 replicates x 3 lots = 441). Data provenance: Spiked Hb-free stool specimens.
- Sample Stability: 441 samples per condition (7 Hb concentrations x 21 replicates x 3 lots = 441). Data provenance: Spiked Hb-free stool specimens.
- Test Kit Shipping Stress Test: 441 samples per condition (7 Hb concentrations x 21 replicates) for each day/temperature condition. Data provenance: Spiked Hb-free stool specimens.
- Sample Shipping Stress Test: 441 samples per condition (7 Hb concentrations x 21 replicates) for each day/temperature condition. Data provenance: Spiked Hb-free stool specimens.
- Method Comparison Study: 953 specimens. Data provenance: Presumably clinical samples collected from Physician Office Laboratory (POL) and Professional Medical Laboratory (PML) settings. The document specifies "three POL sites and three PML sites." This suggests the data is prospective, collected at these clinical sites in the US (implied by POL/PML settings).
- Prozone Effect, Hemoglobin Variants, Cross-Reactivity, Interference: Various spiked concentrations as described. These are laboratory-prepared samples rather than patient samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for most of the foundational studies (cut-off, reaction time, precision, stability, interference) was established using spiked Hb-free stool specimens with known concentrations of human hemoglobin (hHb). This means the "ground truth" was inherently known by the experimental design, not determined by experts.
For the Method Comparison Study, the ground truth for clinical samples was established by the predicate device, Polymedco OC Light FOB Test. Therefore, no independent experts were used to determine the true presence or absence of FOB for these samples; the predicate device results served as the reference.
The "Intensity Reading" study involved 5 readers at one physician office laboratory grading the intensity of the test line. Their qualifications are not specified beyond being "live participant readers at a FOL." This is a qualitative assessment of the test line based on visual interpretation, not a determination of ground truth for fecal occult blood.
4. Adjudication Method for the Test Set
Given that the ground truth for most studies was based on spiked samples with known concentrations, or the predicate device in the method comparison, there was no need for an "adjudication method" in the sense of reconciling disagreements between multiple expert readers. The results were compared directly against the known concentrations or the predicate device's output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted. The primary clinical study was a method comparison study between the new device and a predicate device. This study assessed the agreement between the two devices, not the improvement of human readers with or without AI assistance. The OC-Light S FIT is a qualitative test strip, not an AI-assisted diagnostic tool for interpretation by human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The OC-Light S FIT is described as an "in vitro diagnostic device, a qualitative test" and a "lateral flow chromatographic immunoassay." It produces a visible reddish/pink line for positive results. This is a standalone diagnostic device where the result (presence or absence of a line) is visually interpreted by a human, but the device itself does not involve an "algorithm" or "AI" in the modern sense. Its performance as an independent assay is what was evaluated through the various studies (cut-off, precision, stability, interference, method comparison).
7. The Type of Ground Truth Used
- For Cut-off, Reaction Time, Precision/Reproducibility, Test Kit Stability, Sample Stability, Shipping Stress Tests, Hemoglobin Variants, Cross-Reactivity, Interference, Prozone Effect: The ground truth was known concentrations of human hemoglobin (hHb) in spiked, Hb-free stool specimens. This is a laboratory-controlled, artificial ground truth.
- For the Method Comparison Study: The ground truth was established by the predicate device, Polymedco OC Light FOB Test.
8. The Sample Size for the Training Set
The document does not describe a "training set" as it would for a machine learning model. This device is a traditional immunoassay, not an AI/ML product. All described samples are for validation/testing of the device's performance characteristics.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, there is no "training set" or corresponding ground truth establishment process described for this type of device.
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